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. 2022 Feb 7;17(2):e0262858. doi: 10.1371/journal.pone.0262858

Impacts of multisectoral cash plus programs after four years in an urban informal settlement: Adolescent Girls Initiative-Kenya (AGI-K) randomized trial

Beth Kangwana 1,*, Karen Austrian 1, Erica Soler-Hampejsek 2, Nicole Maddox 3, Rachel J Sapire 4, Yohannes Dibaba Wado 5, Benta Abuya 5, Eva Muluve 1, Faith Mbushi 1, Joy Koech 6, John A Maluccio 7
Editor: Catherine E Oldenburg8
PMCID: PMC8820646  PMID: 35130299

Abstract

Background

The vast majority of adolescent births occur in low- and middle-income countries and are associated with negative outcomes for both the mother and her child. A multitude of risk factors may explain why few programs have been successful in delaying childbearing and suggest that multisectoral interventions may be necessary. This study examines the longer-term impact of a two-year (2015–17) multisectoral program on early sexual debut and fertility in an urban informal settlement in Kenya.

Methods

The study used a randomized trial design, longitudinally following 2,075 girls 11–14 years old in 2015 until 2019. The interventions included community dialogues on unequal gender norms and their consequences (violence prevention), a conditional cash transfer (education), health and life skills training (health), and financial literacy training and savings activities (wealth). Girls were randomized to one of four study arms: 1) violence prevention only (V-only); 2) V-only and education (VE); 3) VE and health (VEH); or 4) all four interventions (VEHW). We used ANCOVA to estimate intent-to-treat (ITT) impacts of each study arm and of pooled study arms VE, VEH, and VEHW relative to the V-only arm, on primary outcomes of fertility and herpes simplex virus-2 (HSV-2) infection, and secondary outcomes of education, health knowledge, and wealth creation. Post-hoc analysis was carried out on older girls who were 13–14-years-old at baseline. In 2018, in the VEHW arm, in-depth qualitative evaluation were carried out with adolescent girls, their parents, school staff, mentors, community conversation facilitators, and community gatekeepers. The trial is registered at ISRCTN: ISRCTN77455458.

Results

At endline in the V-only study arm, 21.0 percent of girls reported having had sex, 7.7 percent having ever been pregnant and 6.6 percent having ever given birth, with higher rates for the older subsample at 32.5 percent, 11.8 percent, and 10.1 percent, respectively. In the full sample, ever having given birth was reduced by 2.3 percentage points (pp) in the VE and VEHW study arms, significant at 10 percent. For the older subsample there were larger and significant reductions in the percent ever having had sex (8.2 pp), HSV-2 prevalence (7.5 pp) and HSV-2 incidence (5.6 pp) in the VE arm. Two years after the end of the interventions, girls continued to have increased schooling, sexual and reproductive health knowledge, and improved financial savings behaviors. Qualitatively, respondents reported that girls were likely to have sex as a result of child sexual exploitation, peer pressure or influence from the media, as well as for sexual adventure and as a mark of maturity.

Conclusion

This study demonstrates that multisectoral cash plus interventions targeting the community and household level, combined with interventions in the education, health, and wealth-creation sectors that directly target individual girls in early adolescence, generate protective factors against early pregnancy during adolescence. Such interventions, therefore, potentially have beneficial impacts on the longer-term health and economic outcomes of girls residing in impoverished settings.

Clinical trial registration

ISRCTN registry: ISRCTN77455458; https://doi.org/10.1186/ISRCTN77455458.

Background

Adolescence is a period of rapid physical, cognitive, social, emotional and sexual development. These developmental changes, in association with negative external factors including lack of economic security, unequal gender norms, pressure from peers to engage in sexual activity, pressure from families to achieve economic security through early marriage, and not living with one’s parents are likely to increase the risk of early pregnancy [15]. Girls residing in impoverished settings have greater exposure to these negative external factors and are therefore significantly more likely to engage in unprotected sex at early ages and become pregnant [6]. Globally, 11 percent of all births are to adolescent girls 15–19 years old, with the vast majority (95 percent) of the births occurring in low- and middle-income countries [7].

In Kenya, one in every five girls between 15–19 years is either pregnant or already has a child [8]. Socioeconomically, adolescent childbearing is likely to result in reduced schooling and human capital investment which in turn is likely to lead to reduced job tenure, earnings, and economic empowerment [9]. From a health perspective, complications during pregnancy and childbirth are leading causes of death for females ages 15–24 years [7].

Early sexual initiation is also a known risk factor for herpes simplex virus type 2 (HSV-2) infection in females which has been shown to increase susceptibility to HIV infection two- to threefold and transmission of HIV infection up to fivefold [1013]. Other risk factors for HSV-2 infection include having multiple sexual partners or a history of other sexually transmitted infections (STIs) [12, 13]. Globally, HSV-2 prevalence in 15–19-year-old adolescents is estimated at 7 percent but is as high as 27 percent in rural regions of Western Kenya [14, 15]. Although in rare instances it can be transmitted to neonates during delivery (typically resulting in severe disability or neonatal death) [16, 17]), HSV-2 is almost exclusively sexually transmitted. Because infection leads to the lifelong production of HSV-2 antibodies, their presence is used as a biological marker of prior sexual behavior [18].

Education has been shown to be a critical protective factor in delaying adolescent sexual debut and preventing unintended pregnancy. In Kenya, for example, completing secondary education or higher was found to have reduced the odds of adolescent pregnancy by 67 percent [19]. Studies consistently link education to improved reproductive health outcomes including delayed age at first birth, and demonstrate that school enrollment may be more effective in reducing adolescent childbearing than other reproductive health education interventions [20]. Dropping out of school, however, can be both a result and a cause of early pregnancy, making the pathways through which education and adolescent pregnancy are linked complex. As in many contexts, in Nairobi’s informal settlements there is evidence of a bidirectional association between education and pregnancy, with both higher rates of school dropout among pregnant adolescents, as well as lower likelihood that those enrolled in school will get pregnant [21, 22].

Low socioeconomic status is a risk factor for early pregnancy because adolescents with limited access to economic resources are less able to afford basic care and family planning and are more vulnerable to experiencing child sexual exploitation [5, 23, 24], including having sex in exchange for money or gifts. Cash transfers are a method of promoting economic empowerment and have been shown to increase women’s decision-making power and choices regarding marriage, fertility, and engaging in risky sexual activity [25, 26]. Cash transfers have also been demonstrated to improve school enrollment among adolescent girls which, as described above, has shown to be a protective factor against early pregnancy [25, 26]. There is limited and more mixed evidence, however, on the effectiveness of cash transfers alone versus “cash plus” approaches that combine transfers with additional supportive programming, with some studies indicating that cash transfers alone are insufficient to reduce adolescent pregnancy [26, 27]. Both conditional and unconditional cash transfers have been implemented in a wide array of health interventions with the addition of conditionality not always resulting in better outcomes [22, 25].

Some multisectoral interventions that address multiple areas, such as socioeconomic status, education, and health, and that are therefore able to target overlapping vulnerabilities have been shown to be effective in reducing early pregnancy [28]. Relatedly, in South Africa, combining a monthly grant with other structural and behavioral interventions targeting the caregiver and adolescent led to reductions in HIV incidence [29]. In Tanzania, an intervention consisting of cash plus behavioral intervention addressing gender-equitable attitudes improved attitudes among male participants [30]. In addition, there is evidence that early adolescence is a critical window during which to intervene and prevent the potential negative consequences of pregnancies before they occur. Intervening during this critical period, before negative outcomes crystallize, can improve the well-being of the target population as well as of their offspring, interrupting the transmission of poverty [3133].

The Adolescent Girls Initiative-Kenya (AGI-K) was a randomized trial designed to test the short-term (after two years) and longer-term (after four years) effects of two-year, multisectoral and multilevel “cash plus” programs for young adolescent girls 11–14 years old in two different marginalized areas of Kenya where they face many of the above challenges: 1) Kibera, an urban informal settlement in Nairobi and 2) rural Wajir County on the northeastern border with Somalia. In this study we examine the effects of AGI-K in Kibera after four years (i.e., two years after the end of the program when the girls were 15–18 years old), on the primary outcome of delayed childbearing, as well as a range of secondary outcomes. Short-term results and results after four years for Wajir are reported elsewhere [34, 35].

Methods

Intervention context

Kibera is the largest urban informal settlement in Kenya and is characterized by high population density (more than 20,000 people per square kilometer) alongside substantial residential mobility, and has low-quality housing, high crime rates, minimal government services, and multiple religious and ethnic groups, though large pluralities identify as Luhya (38 percent) and Luo (28 percent) [36]. The characteristics and deprivations of Kibera are similar to other urban settings in Kenya [37] as well as to other urban areas in Africa where more than 50 million people live [38]. Forty-three percent of girls 15–19 years old living in urban informal settlements are not in school, mainly because of their inability to pay school fees. In 2006, 60 percent of adolescent girls 10–19 years old in Kibera felt there was a lot of crime in their neighborhood and feared they would be sexually assaulted [39]. Although the median age of first marriage in Nairobi informal settlements is 22 for 25–39 year-olds, one-quarter of 20–24 year-olds initiated sexual activity by the time they were 16 years old [8, 39]. Childbearing among 15–17-year-olds in informal settlements is much higher than in the rest of Nairobi, as is the portion reporting that their pregnancy was unintended, which was approximately one-half in informal settlements compared to just over one-third in the rest of Nairobi [36]. Fig 1 presents the enrollment of girls into the study, described in more detail below.

Fig 1. Individual sample flow including reasons for loss to follow-up.

Fig 1

1If the first random selected girl was later determined ineligible or was unavailable, an eligible sister was substituted in her place in the baseline survey. 2The baseline completed sample was the target sample at endline.

Theory of change

Fig 2 presents the theory of change underpinning the multisectoral, multilevel cash plus AGI-K programs [40]. This theory was originally based on a combination of an asset-building theory of change—that posits that girls need a combination of education, social, health, and economic assets to make a safe, healthy, and productive transition from childhood into young adulthood [41, 42]—as well as an ecological framework for adolescent health that takes into account the various levels in society that shape those outcomes [43]. The figure outlines how interventions in the violence prevention and education sectors targeting the community and the household are combined with interventions in the education, health, and wealth-creation sectors targeting the individual girl. The interventions are designed to work in concert to empower the girls, improving their “ability to formulate strategic choices, and to control resources and decisions that affect important life outcomes” [44]. We hypothesized that the interventions would affect household norms and economic assets, and adolescent female educational, health, social, and economic assets. The theory of change highlights how these potential short-term benefits, important in their own right, are also mediating factors for the longer-term primary objective of AGI-K: delayed childbearing. Because premarital sex is common in this population (S1 Table), we hypothesized that delayed childbearing would result from delayed sexual debut and/or increased family planning and contraceptive use rather than, for example, delayed marriage.

Fig 2. AGI-K theory of change.

Fig 2

Source: Adapted from Fig 1 open access in Austrian et al. (2016) [40].

Interventions

The AGI-K program packages included nested combinations of four single sector-specific interventions. The four sector-specific interventions are described in Fig 3 and included violence prevention through community conversations (CC) [45] to address sexual and physical violence and the devaluation of girls and women; an education intervention comprised of cash and in-kind transfers conditioned on school enrollment and attendance; health and life skills (HLS) education provided through mentor-led group meetings; and wealth creation including financial education (FE) and savings activities. The theory of change posits complementarities between the different sectors and a common underlying enabling environment in the community. Therefore, rather than examine each single-sector intervention in isolation the study examined the effectiveness of different multisectoral packages of interventions compared with a base intervention addressing violence, implemented throughout the study area so that there was no pure control group in the randomized design (Fig 4). (We return to the implications of this aspect of the study design below in Statistical Methods.) Each intervention component was implemented for two years, from August 2015 through July 2017.

Fig 3. AGI-K Kibera intervention design and take-up.

Fig 3

Note: 1Detailed curricula for HLS and the FE content available at: https://www.popcouncil.org/research/adolescent-girls-initiative-action-research-program.

Fig 4. Intervention packages/study arms.

Fig 4

The Population Council-Kenya oversaw the program which was implemented and comprehensively monitored by the nongovernmental organization (NGO) Plan International. We used administrative data collected by the NGO during program monitoring to summarize key indicators of implementation and take-up for each intervention, and to demonstrate that program fidelity and participation in the interventions were high. All beneficiary girls were registered in an electronic database managed by the Population Council to which the NGO submitted updates via a mobile phone application. The database included enrollment and attendance information maintained to verify compliance with conditions prior to making cash or in-kind transfers, all of which were also included in the database. A standard operating procedures manual was developed including protocols for various potential situations, for example to resolve problems with cash transfer delivery. In addition, each girls group meeting (including date and time, location, identity of mentor, topics covered, and a list of girls in attendance) was captured in the database. The Population Council and the NGO held a two-week training session for mentors at the start of the program and a one-week refresher session at the midpoint. In addition, periodic observation visits for each mentor and her groups were conducted and a checklist used to verify key indicators of implementation quality. Lastly, monthly review meetings were held with all mentors to identify and address challenges and undertake additional training as needed.

Randomization and data collection

By design, all community members living in the study area were exposed to the violence prevention intervention since it operated at the community level throughout the study area. For the other interventions (education, health, and wealth creation), the primary targeted beneficiaries were resident girls 11–14 years old at the start of the program. High population density and widespread availability of schools in Kibera [46] made it possible to reach a large number of girls there with different intervention packages. For example, it was feasible to offer VE to some girls in the study area and VEH to others, inviting the latter to participate in the health intervention girls meetings while the former were excluded from that intervention component. Therefore, we implemented an individual-level randomized design in which the unit of randomization was the girl (and her household).

From November 2014 to January 2015 a complete household census of the study area was done to identify all potentially eligible girls. Girls were eligible for the program if they were 1) 11–14 years old; 2) usually residing in the study area; and 3) not currently enrolled in boarding school, since participation in the locally-based girls meetings would be infeasible for those studying away. Some households had more than one potentially eligible girl. A list with one girl from each household (randomly selecting one girl from households with more than one) was prepared and girls (and their households) on the list were assigned to study arms during a public meeting attended by local leaders and other stakeholders. Random assignment to study arm was done publicly to ensure transparency and strengthen program acceptance in the community. A spreadsheet was projected onto a screen with a line for each girl (identified on the spreadsheet only by an anonymous identification number) and a random number was generated for each girl. The list was put in ascending order based on the generated random number and then divided into four equally sized groups. Each group was assigned to a study arm when four community representatives in turn blindly drew a card from a set of four cards, each indicating one of the study arms.

Subsequently a quantitative baseline survey was administered, prior to unblinding of study arm assignment to girls (and their households) and to the start of the program. Baseline enumerators were similarly blinded to the girl’s study arm assignment. The baseline survey targeted all girls on the list randomized to study arms, but reconfirmed eligibility prior to carrying out an interview. At a later date, study arm assignment was revealed to the interviewed girl and all other eligible girls in her household, if any, were invited to participate in the program in the same study arm. The baseline survey was conducted February–April 2015. All girls interviewed at baseline were targeted for longitudinal follow-up two years later at the end of the program (May–July 2017) and then four years later at endline (April–July 2019) (Fig 1).

To complement the quantitative surveys, we also carried out a qualitative evaluation of the program in April 2018, about nine months after the program had ended. The purpose of the interviews was to assess the enduring perceptions of the strengths and weaknesses of the interventions and the experience and effects of the interventions on participants, as well as to understand knowledge, attitudes, and practices in the communities. In-depth individual semi-structured interviews were carried out with 28 adolescent girls, eight parents and teachers, four mentors, four CC facilitators, and six community gatekeepers. To facilitate efficient investigation of all four interventions the sample of girls was drawn from beneficiaries in the VEHW study arm and was stratified by number of girls group meetings attended (above and below the median) and whether the girl had opened a bank account. Parents were selected from households with a girl included in the qualitative sample. With the assistance of the NGO, the other adult participants in the qualitative interviews were selected based on their knowledge of and experience with the program.

Quantitative methodology

Outcomes

The primary outcomes include binary 0/1 variables measured at endline and equal to one if the girl had ever: 1) had sex; 2) been pregnant; or 3) given birth.

We also directly examined HSV-2, an important health outcome in its own right and also useful as an objectively measured outcome that can be used to corroborate self-reported sexual activity. Trained HIV services counselors collected biological blood specimens via a finger prick for girls 15 years old and older in 2017 and again at endline in 2019 to test for HSV-2 (S2 Text). For the subgroup of girls with HSV-2 measurements, we examined binary 0/1 variables equal to one if the girl: 1) tested positive for HSV-2 at endline (i.e., prevalence in 2019); and 2) tested positive for HSV-2 at endline having tested negative in 2017 at the two-year follow-up, identifying girls who seroconverted from negative to positive between 2017 and 2019 (i.e., incidence between 2017 and 2019). Use of contraceptive methods was logically asked only of girls who reported ever having been sexually active (N = 367), therefore statistical analysis of this indicator was not done for the small, highly selective subsample.

We also pre-specified secondary outcomes within each of the four domains reflecting the underlying mechanisms in the theory of change: violence prevention, education, health (particularly sexual and reproductive health [SRH] knowledge), and wealth creation. We present summary measures for the secondary outcome domains at endline, providing results for their component parts in S6 Table; impacts on the secondary outcomes in 2017 at the end of the two-year intervention are reported elsewhere [35]. Variable definitions are provided in S7 Table.

Sample size and power analysis calculations

A minimum detectable effect (MDE) approach was used to conduct a power analysis based on the number of potential beneficiaries who could be covered by the program budget and included in the survey, approximately 3,000 across the four study arms. MDEs comparing each of the VE, VEH, or VEHW study arms to the V-only study arm were estimated for prevalence of first birth at endline [40]. Setting the power at 80 percent and the significance level at 5 percent, power analysis was conducted for two-sample proportions tests in the statistical analytical software STATA because each comparison involved two groups, one study arm with a package of interventions (e.g., VE) compared to the V-only study arm. Based on the 2012 Nairobi Cross-Sectional Slum Survey (NCSSS) [36], we assumed that 15.4 percent of girls in the V-only study arm would have given birth by endline when girls in the sample were 15–18 years old. Using individual randomization and an estimated final sample size of 600 girls per arm (3,000/4 = 750 girls per study arm at baseline, assuming a loss to follow-up of 20 percent over the four years) allowed an MDE difference of 5.4 percentage points between the V-only and each of the other study arms. Because of a higher-than-expected proportion of ineligible girls after complete enumeration of the study area, however, the attained baseline sample included approximately 600 girls per arm, which after an assumed rate of 20 percent attrition allowed for an MDE of 6.3 percentage points.

Statistical methods

We assessed balance on baseline characteristics across the randomized study arms for the sample reinterviewed at endline to explore potential bias from nonrandom attrition. We also assessed attrition using ordinary least squares to estimate the probability of reinterview at endline and examined whether correlates of attrition differed by study arm.

We then estimated the intent-to-treat (ITT) effect of each package of interventions relative to the V-only arm at endline. Because the violence prevention intervention was included in all study arms, the research was not designed to estimate the impact of that intervention alone. ITT was defined as a girl (and her household) assigned at baseline to a specific study arm, irrespective of her actual participation in the AGI-K programs. Analysis of covariance (ANCOVA) models were used in which the baseline value for the outcome variable, when available, was included as a control.

Because three interrelated primary-outcomes indicators were evaluated, we also combined them into a single summary measure to account for concerns related to multiple hypothesis testing. For each individual primary outcome we calculated a z-score based on the mean and standard deviation (SD) of the V-only study arm at endline. Using those, we constructed an inverse covariance weighted index, restandardizing to be mean 0 and SD 1 [47]. We then estimated the same ITT model on this summary z-score in which coefficient estimates reflect changes measured in standard deviations. The same methodology was applied to construct summary measures for the secondary outcomes.

All regressions included controls for age and, when available, the baseline value of the outcome measure for the ANCOVA. In addition, per the study protocol [40] we report regressions with additional controls for baseline schooling, cognitive skills, parental characteristics and household wealth to improve precision and account for any initial imbalance [40]. We also examined results combining all three study arms with the education conditional cash transfer (VE, VEH and VEHW) into a single indicator and estimated the average overall effect of those three pooled study arms compared to V-only. We conducted subgroup analysis on girls 13 years old and older at baseline, the subgroup for whom HSV-2 testing was done both at the two-year follow-up in 2017 and again at endline in 2019. Because of their older ages, this subgroup was more likely to have begun having sex, become pregnant or given birth at endline. We consider this analysis post-hoc because it was not outlined in the original study protocol [40]. Finally, as an additional sensitivity analysis, we constructed inverse probability weights (IPW) based on a comprehensive model of attrition, reporting weighted results in the supplementary appendix.

All regressions were estimated with robust standard errors and we set statistical significance at 5 percent. Statistical analysis was conducted using STATA 15.1.

Qualitative methodology

In order to conduct the qualitative evaluation of the trial, the interviewers and focus group moderators followed semi-structured interview guides which had questions and probes on topics related to AGI-K including individual attitudes on and experiences with the various intervention components; community impressions of and involvement in the program; and community attitudes and norms related to gender, gender-based violence, romantic/sexual relationships, and family planning among adolescent girls. Interview guides were available in English and Swahili, the national languages of Kenya, and the interviews were conducted in the respondent’s language of choice. The interviews were conducted by trained interviewers and moderators, and interviewers and respondents were matched by gender.

All interviews were recorded with participant permission and transcribed directly into English. Following transcription, all transcripts were validated and reviewed for quality assurance by a second validator prior to being coded. No personal identifying information, other than the assigned participant identification were included in the transcriptions. An initial starting list of codes was developed and included in a code-book based on the program’s theory of change and interview guides, and then additional codes were added as new themes emerged from the data [48]. All transcripts were double-coded by two qualified analysts using ATLAS.ti. To test for intercoder agreement across the double-coded transcripts, a Krippendorff’s [49] c-α-binary coefficient was obtained for all key codes. For cases where the coefficient was less than 0.70, side-by-side comparison, clarification, and reconciliation were carried out on the specific coded transcripts.

Ethical approval

The Population Council Institutional Review Board (IRB) (protocol (p) 661) and the AMREF Ethics and Scientific Review Committee (p143-2014) approved the study in 2014 prior to any contact with participants or enrollment. In addition, all necessary research permits were obtained from the Kenyan National Council for Science, Technology and Innovation (P/18/6952/25330). Written informed consent was obtained from all girls 18 or older; written parental or guardian consent was obtained for girls under 18 years old, with those girls providing oral assent. Upon completion of a draft study protocol paper in 2015 [40], the unchanged trial was also retrospectively registered in the ISCRTN registry (ISRCTN77455458) as was required for journal submission; the authors confirm that all ongoing and related trials for this intervention are registered.

Results

Intervention take-up—Quantitative and qualitative findings

For the targeted adolescent girls, take-up of the educational components of the intervention was high; 90 percent or more of girls randomized to a study arm including the education intervention received at least one household cash transfer, and out of a possible 12 transfers on average girls received 9.5 (SD 3.7) transfers, with median of 11 transfers (Table 1). Transfers of school fee payments and receipt of in-kind supply kits were similarly high relative to the potential maximum. There were no transfers made to girls in the V-only arm. Attendance at the health and life skills sessions was also high. Over 90 percent of girls in the VEH and VEHW study arms attended at least one of the health and life skills sessions. Overall attendance at group meetings was higher among girls in the VEHW arm than in the VEH arm; however because of the design with the same overall number of group meetings, on average girls in the VEH arm had higher exposure to the health and life skills curriculum than girls in the VEHW arm. By design, girls in VE were not included in the group meetings though administrative data indicate that a negligible fraction attended. Of the girls in the VEHW study arm, 92 percent attended at least one FE session and over the course of the intervention, attended on average 10.5 (SD 7.0) group meetings covering FE. More than 75 percent of girls attended at least four FE sessions. By design, group sessions for girls in the VEH arm did not include the FE curriculum, although administrative data indicate that a few FE sessions were offered to a small number of groups in the wrong study arm with approximately 3 percent of girls in VEH apparently exposed to a FE session outside their study arm. All indicators of take-up for girls in the endline analytical sample examined in the paper were similar or slightly higher.

Table 1. AGI-K Kibera intervention take-up, by study arm.

V-only VE VEH VEHW Overall1
Education intervention
Received at least one cash transfer, % 0.0 92.7 90.1 94.6 92.5
Cash transfers received (out of 12), mean 0.0 9.4 9.2 9.9 9.5
School fee payments received (out of 6), mean 0.0 4.9 4.9 5.0 5.0
School kits received (out of 6), mean 0.0 4.1 4.1 4.4 4.2
Health intervention
Total group meetings attended,2 mean 0.0 0.0 34.5 37.6 36.0
Attended at least 12 group meetings, % 0.0 0.2 77.5 82.8 80.1
Health and life skills sessions attended, mean 0.0 0.0 34.3 27.0 30.7
Wealth-creation intervention
Financial education sessions attended, mean 0.0 0.0 0.1 10.5 10.5
Attended at least 4 financial education sessions, % 0.0 0.0 2.1 80.7 80.7
Received both annual savings incentives, % 0.0 0.0 0.0 78.7 78.7
Opened savings account, % 0.0 0.5 0.3 81.9 81.9
N 597 592 609 592 2,390

Source: Program administrative data collected during program monitoring by the implementing NGO.

1 Overall average across applicable study arms (VEH and VEHW for health intervention and VEHW for wealth-creation intervention).

2 Groups met weekly over two years for a maximum of ~100 meetings.

Community conversation experiences

Respondents noted that initially there was good attendance at the CC meetings however, this decreased over time partly due to a lack of commitment by some participants in the absence of individual monetary incentives. In addition, other responsibilities made it difficult to always attend the meetings. Some respondents indicated that participants were predominantly female.

‘Soin future if you need to meet the parents, you should send a text message via phone. For example, if you need us on Saturday, send us the message by Friday or Thursday so I can plan my work and make time for PLAN [CC meetings organized by Plan International].’

Father (unknown age).

In the qualitative interviews, respondents who participated in the CC violence prevention meetings indicated the meetings covered a range of topics including parenting, challenges facing adolescents, violence resolution, and education. (The qualitative sample is described further below). Participants reported matters of concern to the communities were discussed openly and that they learned useful parenting lessons.

Before then, when violence was meted against a girl, the parents did not know how to pursue the cases and they used to be paid something small by the perpetrators and they kept silence. At least right now people are informed that they know what to do to fight people who violate girls, that voice can be heard in the community.’

CC facilitator, male (unknown age).

Intervention effects—Quantitative and qualitative findings

Fig 1 presents the detailed sample flow by study arm. After complete enumeration of the study areas, there were fewer eligible girls than the 3,000 anticipated in the design. At baseline assessment for eligibility, the target baseline sample for interview was 2,548 girls, of whom 2,390 were interviewed, with similar rates of nonresponse (5.7–6.5 percent) across study arms (prior to informing individuals of treatment status). Because there was substantial residential mobility for girls, to keep attrition to a minimum we implemented brief periodic tracking surveys, updating location and contact information between comprehensive survey rounds. In April–July 2019, 2,075 (86.8 percent) baseline girls were reinterviewed with rates differing across study arms (80.7–89.9 percent). Despite tracking girls to 31 of 47 counties throughout Kenya, one common reason for loss to follow-up was not being able to locate girls who had moved; a second common reason, particularly in the V-only study arm, was refusal.

Table 2 presents means at the start of the program for the sample of girls reinterviewed at endline. At baseline, the girls averaged 12.6 years old and about half lived with their parents. Two-thirds of mothers and three-quarters of fathers had themselves completed primary school. Almost one-third of girls had experienced violence by a male in the past year. Virtually all were enrolled in school, over 90 percent were literate, and average grade attainment was 5.7 years. SRH knowledge at baseline was low and less than 2 percent of girls reported having had sex, been pregnant, or given birth (S2 Table). The endline samples were balanced on a range of baseline characteristics across study arms, with no large or statistically significant differences. S2 Table reports means by study arm for the full baseline sample, and shows similar patterns [50].

Table 2. Baseline means for endline analytical sample, by study arm.

(1) (2) (3) (4) (5)
V-only VE VEH VEHW p-value
Background
Age in years, mean (SD) 12.6 (1.2) 12.5 (1.3) 12.6 (1.3) 12.5 (1.2) 0.573
Cognitive score (0–16), mean (SD) [n = 2,059] 8.2 (3.1) 8.4 (3.0) 8.4 (3.2) 8.3 (3.1) 0.614
Lives with both parents (= 1), % [n = 2,058] 51.7 57.0 51.1 53.9 0.219
Mother completed primary school (= 1), % [n = 1,934] 63.6 64.0 62.8 64.4 0.962
Father completed primary school (= 1), % [n = 1,714] 76.2 79.6 74.9 79.1 0.274
Violence prevention
Experienced violence by a male in the past year (= 1), % 29.5 29.5 30.2 32.0 0.807
Positive gender attitudes score (0–4), mean (SD) 3.6 (0.7) 3.6 (0.7) 3.6 (0.7) 3.6 (0.7) 0.820
Education
Grade attainment, mean (SD) 5.7 (1.4) 5.7 (1.3) 5.7 (1.3) 5.6 (1.4) 0.659
Primary school complete (= 1), % 7.9 5.9 6.9 6.0 0.570
Enrolled in school (= 1), % 99.2 99.1 98.3 99.2 0.550
Literate in Swahili and English (= 1), % [n = 2,059] 91.9 94.1 94.1 94.1 0.448
Health
Knows most fertile period during menstrual cycle (= 1), % 8.3 7.6 7.1 5.8 0.450
General self-efficacy score (0–6), mean (SD) 3.9 (1.7) 4.0 (1.6) 4.0 (1.6) 3.9 (1.6) 0.735
Wealth creation
Financial literacy score (0–10), mean (SD) [n = 2,014] 5.7 (1.9) 5.7 (1.9) 5.7 (1.9) 5.7 (1.8) 0.946
Saved money in the past six months (= 1), % [n = 2,014] 27.6 25.2 25.9 29.1 0.475
Worked for income in the last year (= 1), % 10.6 12.3 10.9 10.3 0.756
Household-level
Household expects girl to complete secondary (= 1), % [n = 2,117] 99.8 99.6 99.8 100.0 0.261
Household wealth quintile (1–5), mean (SD) [n = 2,132] 3.1 (1.4) 3.1 (1.4) 3.0 (1.4) 3.0 (1.4) 0.395
Sample by arm when n = 2,075 482 528 533 532

Notes: P-values in column 5 are from an F-test for joint differences across study arms for sample of nonattritors at endline. N = 2,075 unless otherwise noted. Sample sizes are larger for household-level variables because for some observations the household but not the individual survey was completed. All statistical tests were carried out using robust standard errors.

*** p<0.001,

** p<0.01,

* p<0.05,

p<0.1.

Linear probability models predicting reinterview at endline are presented in S3 Table. The probability of reinterview was lower for the V-only study arm and higher for the youngest girls, those with higher completed grades, and those who resided with both parents. Expanding the model to include interactions of the controls with an indicator for each study arm, there were no significant differences in the relationships between the covariates and attrition in each study arm. This pattern, alongside the evidence of balance across study arms after attrition (Table 2), suggests that although there was measurable attrition, large systematic biases threatening internal validity are unlikely.

Table 3 presents results from the ITT analyses on the primary outcomes for the full sample in the top panel and for subgroup analysis of girls 13 years old and older at baseline in the bottom panel. At endline in the V-only study arm for the full sample, 21.0 percent of girls reported ever having had sex, 7.7 percent had ever been pregnant, and 6.6 percent had ever given birth. The majority of the estimated ITT effects (compared to V-only) on the primary outcomes and summary measure in columns 2–4 are negative. However, only the effects for ever having given birth in the VE and VEHW study arms are significant at 10 percent. Magnitudes of the estimated ITT effects with extended controls are similar. There was a nearly 0.1 SD reduction in the fertility outcomes summary measure for the VEHW study arm, also significant only at 10 percent. Estimates accounting for further potential attrition bias by reweighting with IPW (S1 Text) indicated similar reductions for the summary fertility indicator in both the VE and VEHW study arms (S4 Table), consistent with the evidence on balance across study arms after attrition.

Table 3. Estimated intent-to-treat effects on primary outcomes at endline, by study arm.

(1) (2) (3) (4) (5) (6) (7) (8) (9)
V-only endline mean VE estimate VEH estimate VEHW estimate VE-VEH-VEHW pooled estimate VE estimate: extended controls VEH estimate: extended controls VEHW estimate: extended controls VE-VEH-VEHW Pooled estimate: extended controls
Full sample
Ever had sex (= 1) 0.210 -0.033 -0.037 -0.032 -0.034 -0.031 -0.042 -0.031 -0.034
 95% CI [-0.08, 0.01] [-0.08, 0.01] [-0.08, 0.01] [-0.07, 0.00] [-0.08, 0.01] [-0.09, 0.00] [-0.08, 0.01] [-0.07, 0.00]
Ever pregnant (= 1) 0.077 -0.014 0.006 -0.018 -0.009 -0.014 0.002 -0.019 -0.010
 95% CI [-0.04, 0.02] [-0.03, 0.04] [-0.05, 0.01] [-0.03, 0.02] [-0.04, 0.02] [-0.03, 0.03] [-0.05, 0.01] [-0.04, 0.02]
Ever given birth (= 1) 0.066 -0.023 0.007 -0.023 -0.013 -0.023 0.002 -0.024 -0.015
 95% CI [-0.05, 0.00] [-0.02, 0.04] [-0.05, 0.00] [-0.04, 0.01] [-0.05, 0.00] [-0.03, 0.03] [-0.05, 0.00] [-0.04, 0.01]
Fertility outcomes summary index z-score 0.000 -0.090 -0.035 -0.092 -0.072 -0.086 -0.048 -0.090 -0.075
 95% CI [-0.20, 0.02] [-0.15, 0.08] [-0.20, 0.01] [-0.16, 0.02] [-0.19, 0.02] [-0.16, 0.07] [-0.19, 0.01] [-0.17, 0.02]
Baseline 13–14-year-olds [n = 1,007]
Ever had sex (= 1) 0.325 -0.082* -0.062 -0.063 -0.069* -0.085* -0.071 -0.061 -0.072*
 95% CI [-0.16, -0.01] [-0.14, 0.01] [-0.14, 0.01] [-0.13, 0.00] [-0.16, -0.01] [-0.15, 0.00] [-0.14, 0.01] [-0.14, -0.01]
Ever pregnant (= 1) 0.118 -0.023 0.016 -0.018 -0.008 -0.022 0.013 -0.015 -0.008
 95% CI [-0.08, 0.03] [-0.04, 0.07] [-0.07, 0.04] [-0.05, 0.04] [-0.07, 0.03] [-0.04, 0.07] [-0.07, 0.04] [-0.05, 0.04]
Ever given birth (= 1) 0.101 -0.026 0.013 -0.024 -0.012 -0.026 0.008 -0.023 -0.014
 95% CI [-0.07, 0.02] [-0.04, 0.07] [-0.07, 0.02] [-0.05, 0.03] [-0.07, 0.02] [-0.04, 0.06] [-0.07, 0.02] [-0.05, 0.03]
Fertility outcomes summary index z-score 0.000 -0.136 -0.047 -0.111 -0.098 -0.139 -0.064 -0.106 -0.103
 95% CI [-0.29, 0.02] [-0.22, 0.12] [-0.27, 0.05] [-0.23, 0.04] [-0.30, 0.02] [-0.23, 0.10] [-0.26, 0.05] [-0.23, 0.03]
HSV-2 positive1 (= 1) [n = 938] 0.204 -0.075* 0.029 -0.043 -0.029 -0.072* 0.033 -0.041 -0.026
 95% CI [-0.14, -0.01] [-0.05, 0.10] [-0.11, 0.03] [-0.09, 0.03] [-0.14, 0.00] [-0.04, 0.11] [-0.11, 0.03] [-0.09, 0.03]
HSV-2 incidence 2017-192 (= 1) [n = 740] 0.091 -0.056* -0.007 -0.023 -0.029 -0.055* -0.005 -0.022 -0.028
 95% CI [-0.11, 0.00] [-0.07, 0.05] [-0.08, 0.03] [-0.08, 0.02] [-0.11, 0.00] [-0.07, 0.05] [-0.08, 0.04] [-0.08, 0.02]

Notes: Sample is N = 2,075 unless otherwise indicated. Endline means for the V-only study arm are reported in column 1 and the estimated ITT effect for each study arm relative to V-only in columns 2–4. Column 5 pools all three intervention arms with education into a single treatment indicator. Columns 6–9 report estimated ITT effects with extended controls. Numbers in square brackets indicate 95% confidence intervals. Regressions were estimated with robust standard errors and included controls for age and the outcome measured at baseline. The extended control regressions additionally control for baseline measures of: grade attainment, cognitive score, mother or father completing primary school, coresidence with both parents, household wealth quintile, and whether any missing baseline covariates were imputed using area median. 1 No baseline control for outcome variable available. 2 Among respondents who tested HSV-2 negative in 2017.

*** p<0.001,

** p<0.01,

* p<0.05,

p<0.1.

For the subgroup of girls 13 years and older at baseline who were measured at endline in the V-only arm, 32.5 percent reported having ever had sex, 11.8 percent had been pregnant, and 10.1 percent had given birth. Prevalence of HSV-2 among these girls was 20.4 percent, with 9.1 percent of the girls who tested negative in 2017 seroconverting and testing positive by 2019. Estimated effects on ever having had sex and prevalence and incidence of HSV-2 were negative and statistically significant in the VE study arm.

Turning to the secondary outcomes (Table 4), as expected given the experimental design (in which all study arms received the violence prevention intervention), compared to V-only there were no significant effects on the violence prevention summary measures. There were increases in education of 0.1 SD or more, largest for the VE study arm but smaller and significant only at the 10 percent level for the other, more complex study arms in which girls had more program responsibilities. Study arms with the health intervention all increased the health outcome summary score and VEHW had a large effect on wealth creation. Pooling the three study arms with the education component into a single indicator yields clear evidence of positive impacts on the education, health, and wealth summary outcomes of between 0.1 and 0.2 SD. The effects on secondary outcomes were similar or stronger than the effects estimated at the two-year follow-up. For the sample of girls 13 years old and older at baseline, effects were similar for all but the health outcomes summary where effects were more muted, possibly because SRH had increased across arms for all the girls over time. Results for secondary outcomes were robust to weighting for attrition, with point estimates and significance levels changing only slightly (S5 Table). S6 Table presents results for each individual component of the secondary summary measure outcomes. Notably, knowledge of at least one form of modern contraception increased 5 percentage points or more in VE, VEH, and VEHW, and condom self-efficacy increased by 0.13 SD in VEH.

Table 4. Estimated intent-to-treat effects on secondary outcomes summary measures at endline, by study arm.

(1) (2) (3) (4) (5) (6) (7) (8)
VE estimate VEH estimate VEHW estimate VE-VEH-VEHW pooled estimate VE estimate: extended controls VEH estimate: extended controls VEHW estimate: extended controls VE-VEH-VEHW pooled estimate: extended controls
Full sample
Violence prevention outcomes summary index z-score 0.008 0.015 0.003 0.009 -0.013 0.004 0.002 -0.002
 95% CI [-0.12, 0.13] [-0.11, 0.14] [-0.12, 0.13] [-0.09, 0.11] [-0.13, 0.11] [-0.12, 0.12] [-0.12, 0.13] [-0.10, 0.10]
Education outcomes summary index z-score 0.175** 0.096 0.108 0.126** 0.146** 0.090 0.100 0.112*
 95% CI [0.07, 0.28] [-0.02, 0.21] [0.00, 0.22] [0.03, 0.22] [0.04, 0.25] [-0.02, 0.20] [-0.01, 0.21] [0.02, 0.20]
Health outcomes summary index z-score 0.095 0.187** 0.126* 0.136** 0.069 0.167** 0.119 0.119*
 95% CI [-0.03, 0.22] [0.07, 0.31] [0.00, 0.25] [0.04, 0.24] [-0.05, 0.19] [0.05, 0.28] [0.00, 0.24] [0.02, 0.22]
Wealth creation outcomes summary index z-score 0.158* 0.108 0.407*** 0.225*** 0.128* 0.093 0.407*** 0.210***
 95% CI [0.04, 0.28] [-0.02, 0.23] [0.29, 0.53] [0.12, 0.33] [0.01, 0.25] [-0.03, 0.21] [0.29, 0.52] [0.11, 0.31]
Baseline 13–14-year-olds [n = 1,007]
Violence prevention outcomes summary index z-score 0.002 -0.041 0.012 -0.009 -0.032 -0.071 -0.002 -0.036
 95% CI [-0.17, 0.17] [-0.21, 0.13] [-0.17, 0.19] [-0.15, 0.13] [-0.20, 0.13] [-0.24, 0.10] [-0.18, 0.17] [-0.17, 0.10]
Education outcomes summary index z-score 0.243** 0.116 0.159* 0.172* 0.220** 0.105 0.139 0.154*
 95% CI [0.09, 0.40] [-0.05, 0.28] [0.00, 0.32] [0.04, 0.31] [0.07, 0.37] [-0.06, 0.27] [-0.01, 0.29] [0.02, 0.28]
Health outcomes summary index z-score 0.040 0.183* 0.161 0.128 -0.012 0.141 0.117 0.082
 95% CI [-0.13, 0.21] [0.01, 0.36] [-0.03, 0.35] [-0.02, 0.27] [-0.18, 0.16] [-0.03, 0.31] [-0.07, 0.30] [-0.06, 0.22]
Wealth creation outcomes summary index z-score 0.198* 0.114 0.367*** 0.225** 0.157 0.079 0.343*** 0.193**
 95% CI [0.02, 0.37] [-0.06, 0.29] [0.20, 0.54] [0.08, 0.37] [-0.02, 0.33] [-0.10, 0.25] [0.18, 0.51] [0.05, 0.33]

Notes: Sample is N = 2,075 unless otherwise indicated. The table reports the estimated ITT effect for each study arm relative to the V-only study arm measured in z-scores in columns 1–3. Column 4 pools all three intervention arms with education into a single treatment indicator. Columns 5–8 report estimated ITT effects with extended controls. Numbers in square brackets indicate 95% confidence intervals. Regressions were estimated with robust standard errors and included controls for age and the outcome measured at baseline. The extended controls regressions additionally control for baseline measures of: grade attainment, cognitive score, mother or father completing primary school, coresidence with both parents, household wealth quintile, and whether any missing baseline covariates were imputed (using area median). Z-scores are calculated separately for the full and baseline 13–14 year-old samples.

*** p<0.001,

** p<0.01,

* p<0.05,

p<0.1.

The sample of participants interviewed in the qualitative evaluation (discussed above) is shown in Table 5. All adolescent girls interviewed were under 18 years old, 68 percent (n = 19) were in secondary school, none had been married, and around 80 percent (n = 22) were Protestant. Girls were selected to represent different levels of group session participation and access to a personal bank account. Of the parents who were interviewed, 36 percent (n = 3) were mothers. Gatekeepers included religious leaders and chiefs within the community. Below we explore the qualitative findings from the subthemes that were identified from the core themes of education, schooling, sexual behavior, and marriage.

Table 5. Socio-demographic characteristics of participants in the qualitative interviews.

Variables Adolescents (n(%)) (N = 28) Parents (n(%)) (N = 8) Mentors (n(%)) (N = 4) Teachers (n(%)) (N = 8) CC facilitators (n(%)) (N = 4) Gatekeepers (n(%)) (N = 6) Totals (n(%)) (N = 58)
Sex
 Male 0 (0) 5 (62.5) 0 (0) 4 (50) 4 (100) 4 (66.7) 17 (29.3)
 Female 28 (100) 3 (37.5) 4 (100) 4 (50) 0 (0) 2 (33.3) 41 (70.7)
Age
 Below 18 28 (100) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 28 (48.3)
 18-–29 0 (0) 0 (0) 4 (100) 1 (12.5) 1 (25) 0 (0) 6 (10.3)
 30–39 0 (0) 2 (25) 0 (0) 4 (50) 3 (75) 1 (16.7) 10 (17.2)
 40–49 0 (0) 5 (62.5) 0 (0) 2 (25) 0 (0) 2 (33.3) 9 (15.5)
 50+ 0 (0) 1 (12.5) 0 (0) 1 (12.5) 0 (0) 3 (50) 5 (8.6)
Education
 Primary 9 (32.1) 4 (50) 0 (0) 0 (0) 0 (0) 0 (0) 13 (22.4)
 Secondary 19 (67.9) 4 (50) 3 (75) 0 (0) 0 (0) 4 (66.7) 30 (51.7)
 University/college 0 (0) 0 (0) 1 (25) 8 (100) 4 (100) 2 (33.3) 15 (25.9)
Marital status
 Never married 28 (100) 0 (0) 1 (25) 0 (0) 0 (0) 0 (0) 29 (50)
 Married 0 (0) 6 (75) 2 (50) 8 (100) 4 (100) 6 (100) 26 (44.8)
 Separated 0 (0) 2 (25) 1 (25) 0 (0) 0 (0) 0 (0) 03 (5.2)
Religion
 Catholic 3 (10.7) 0 (0) 2 (50) 5 (62.5) 1 (25) 2 (33.3) 13 (22.4)
 Protestant 22 (78.6) 7 (87.5) 2 (50) 3 (27.5) 3 (75) 4 (66.7) 41 (70.7)
 Muslim 3 (10.7) 1 (12.5) 0 (0) 0 (0) 0 (0) 0 (0) 4 (6.9)
 Other 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Occupation
 Student 28 (100) 0 (0) 1 (25) 0 (0) 0 (0) 0 (0) 29 (50)
 Teacher 0 (0) 0 (0) 0 (0) 8 (100) 3 (75) 0 (0) 11 (19)
 Business 0 (0) 2 (25) 1 (25) 0 (0) 0 (0) 3 (50) 06 (10.3)
 Other 0 (0) 6 (75) 2 (50) 0 (0) 1 (25) 3 (50) 12 (20.7)

Barriers to education

The reported barriers to education included lack of school fees, pregnancy, peer pressure, child sexual exploitation, and drug abuse. Respondents suggested several potential ways to overcome these barriers and improve learning outcomes which included paying school fees on time, providing materials such as books, hiring more teachers, and empowering girls.

First, its the issue of school fees. It should get the student in school the right time. Then, also, you know for some girls, if you havent understood something, you fear asking. You fear the teacher. So, they should speak.”

Adolescent, female (unknown age).

‘The problems that they face at home are like rape, child labor, peer pressure from their fellow age mates, and mostly the biggest problem is the poverty thing. The poverty streamline is on a very high standard and you find that these children undergo a lot, and by doing that it might hinder them from going to school.’

Teacher, male, 39.

Educational support experiences

Respondents reported that the effects of the education conditional cash transfer included increased attendance at school and fewer girls being sent home for not having paid school fees. Families benefited from the household transfer and were able to buy food and clothes for the entire family. The program increased the girls’ own educational goals as well as their parents’ goals for them. Many girls indicated they were more motivated to study and that their goal of attending university had strengthened. Furthermore, respondents indicated that school performance improved as a result of the program.

‘The part where they used to pay feesyoud learn knowing your fees had been paid for by AGI-K at least and mum could add the other. So, your work was just learning and putting in the effort. That is something that it has helped me with.’

Adolescent, female (unknown age).

Girls group meeting experiences

Many girls reported learning important lessons during the girls group meetings, for example on how to maintain hygiene and cleanliness, eat a balanced diet, recognize and protect themselves from sexual and gender-based violence, and delay having sex. Parents and teachers noticed that girls were more open toward them and had greater confidence. Girls also reported enjoying learning how to save money and correspondingly parents observed their increased money management skills and ability to save.

‘What I have seen is good, lets say like now we are depositing for her money, and she is now in form 3. When she reaches form 4, we will continue depositing. So, we are praying to God, that when she completes form fourwe will look for a college for her to enroll or if its a university that she will go to we will contribute with that amount so she can enroll with it.’

Mother (unknown age).

Many respondents commented on the various barriers they faced in attending group meetings regularly, including weekend school sessions; travel to their ancestral villages to visit extended family; and lack of parental understanding, support, or encouragement.

‘When [girls name] got to class 8, she could not attend the meetings because she would go to school even on Sundays. I explained to her that [girls name] would not be coming for the meetings because she had to go for tuition, and they would be beaten up if they didnt go.’

Mother (unknown age).

Sexual motivation and pregnancy prevention

Discussion of sexual behavior in the qualitative interviews elaborated on what motivates girls to engage in sexual relationships and on the circumstances of sex, as well as on pregnancy prevention including common reasons for not using contraception. Respondents reported that girls were likely to engage in exploitative sex for the actual or expected gain of money and gifts and because of peer pressure or influence from the media, but also as a mark of maturity and for sexual adventure.

I think that at times its the anxiety and the need to discover themselves; they want identity, through peer pressure, and the economic challenges that the girls face. For the older men they could be using money and gifts to lure the girls into that kind of relationship. And again, the parents could not be seeing it as a sin because they see that my daughter is bringing sugar, so its confusion and it is a chain of things.”

Community gatekeeper, male, 46.

Respondents reported that most girls were aware of family planning methods such as male condoms, pills, and implants as well as where to obtain contraceptives. Some of the reasons cited for not using contraceptives during sex included an inability to negotiate male condom use, having unplanned sex, wanting to avoid experiencing side effects of certain family planning methods, and being the victim of sexual violence. Other reasons included a partner promising to marry them if they became pregnant or wanting to have a child.

You know maybe a boy may have lied that he will marry you, and then when he gets you pregnant, he runs away or maybe he rejects that the pregnancy is not his.”

Adolescent, female, 14.

Those pills have their side effects especially the many pills that have been introduced into the market; they have many side effects.”

Adolescent, female, 16.

Discussion

In this paper, we report on the effects, of the AGI-K interventions in Kibera targeting young adolescent girls in 2019, two years after the program ended. Although significant at only 10 percent, the percent of girls who had ever given birth was one-third lower among those exposed to the education intervention (VE) or to the full range of intervention components (VEHW), compared to the V-only study arm. The girls were still relatively young (16 years old on average) at the time of the endline survey, however, raising the possibility that program impacts could increase further as they transition to young adulthood. Supporting that possibility are the results for the older subsample of girls who were 13 years old or older at baseline (18 years old on average at endline); these girls had lower outcomes on the fertility summary index in the VE study arm, driven largely by delaying sexual debut.

The reduced fertility outcomes in the VE study arm were corroborated by significantly lower HSV-2 prevalence and incidence in that study arm. Because HSV-2 is almost exclusively transmitted through genital-to-genital contact during sex [51] it has been shown to be reliable marker of sexual behavior [52]. Notably, the findings for HSV-2, a one-third reduction in prevalence and almost two-thirds reduction in incidence, have important beneficial health implications in their own right. Findings from the qualitative study identified a variety of reasons why girls engage in exploitative sexual practices, including for the actual or expected gain of money and gifts. It is possible that the cash transfers played a role in reducing girls’ vulnerability to such practices.

Most adolescent pregnancy in Kibera occurs outside of marriage. One of the aims of the focus on SRH knowledge and self-efficacy in the health intervention was to promote changes in sexual behavior, by delaying sexual debut as well as by increasing the ability to negotiate for contraceptive use during sex [53]. Both the quantitative and qualitative findings demonstrated that most girls were knowledgeable about modern contraceptive methods. We were unable to provide quantitative evidence on the effects of the intervention on contraceptive use. The qualitative findings, however, revealed that despite knowledge of methods there remain limitations to use due to girls’ inability to negotiate condom use, unplanned sex, fear of experiencing side effects, or wanting to become pregnant. Incomplete contraceptive use in this young sample is consistent with patterns observed across sub-Saharan Africa where women 15–24 years old are found to be more likely to start using contraception after their first birth [54].

Consideration of potential underlying mechanisms, the secondary outcomes in our study, also revealed a number of findings two years after the program ended. Perhaps most important was that the effects were similar to or greater than those estimated at the end of the programs, indicating persistent effects following the early adolescent interventions. More specifically, positive effects were observed in the education outcomes summary index when compared to the V-only study arm. In particular, the pooled study arms estimate showed a significant increase in grade attainment. School enrollment was already high for this age group, likely explaining why there was only minimal impact observed for the other quantitative education indicators such as enrollment. These findings are consistent with qualitative results that identified lack of school fees as a barrier to education. Respondents in the qualitative evaluation reported that the cash transfers increased school attendance, motivation to study and ambition to attend university, as well as reduced the number of girls sent home for unpaid fees.

Persistent positive impacts were similarly observed in the health outcomes summary index for girls in a study arm with the health intervention (VEH and VEHW). Findings from the qualitative survey support the quantitative effects with girls reporting increased SRH knowledge. Parents and teachers also reported positive behavioral change including girls becoming more confident and being more open.

Persistent positive impacts also were observed in the wealth-creation domain, concentrated in the study arm with the wealth intervention. Girls in the VEHW arm had significantly and substantially higher financial literacy scores and were more likely to have saved money, demonstrating that knowledge conveyed in the financial literacy sessions translated into positive behavior change. In line with these observations, the qualitative survey revealed that girls enjoyed learning how to save money and were supported by their parents to do so.

Without a pure control group receiving no intervention, our research design does not identify the impact of the violence prevention study arm alone. Results examining the effect of the other study arms on violence prevention outcomes, however, indicate that there were no effects above and beyond any possible impacts of the violence prevention intervention itself. Qualitative findings highlighted some challenges experienced in implementing the intervention, including low attendance at CC meetings; hence, although resources were delivered and plans completed, it is unclear how efficacious the intervention was.

The theory of change identifies the potential intermediate benefits from the interventions on household norms and economic assets, and on adolescent female educational, health, social, and economic assets, as mediating factors for the longer-term primary objective of delayed childbearing. Earlier work demonstrated that at the end of the intervention in 2017, girls exposed to the VEHW arm had positive effects on grade attainment and large impacts on completion of primary school and transition to secondary school, as well as improved financial literacy and savings behavior. In addition, girls exposed to the health component had improved SRH knowledge and condom-self efficacy [35]. The current study shows that not only did the effects on these mediating factors persist two years after the end of the interventions, but that there was also evidence of longer-term impacts on delayed sexual debut and marginal decreases in adolescent pregnancy.

There are several limitations to this study. First, it was not feasible to implement a full factorial design in which we could also have assessed, for example, the impact of the girls’ empowerment groups alone. Second, we are unable to generalize the findings to settings beyond urban informal settlements. Third, the baseline and final quantitative samples were smaller than the target sample because of a lower-than-expected population of eligible girls, thus decreasing power and increasing the MDEs. Fourth, there was a possibility of internal spillover of resources or knowledge to girls in the V-only study arm from girls in other arms, possibly reducing estimated program impacts. Finally, we were unable to evaluate the pathway of increased contraceptive use in delaying childbearing because of the relatively small sample of girls reporting ever having sex by endline.

At the same time, the study has significant strengths. It is one of few studies using a randomized, longer-term, longitudinal design to examine multisectoral cash plus interventions in a marginalized population. Such follow-up is essential for understanding program impacts on adolescents since early investments may only pay dividends years later, well after the interventions have ended [55]. Fidelity and take-up of the programs were high and there was virtually no program contamination. The study employed a rigorous randomized design with minimal attrition. We were able to corroborate results for self-reported sexual behavior with results for HSV-2 prevalence and incidence, more reliable markers of sexual activity. And last, it was possible to triangulate the quantitative results with qualitative findings from the same sample.

Results from this study demonstrate the potential beneficial effects of multisectoral cash plus interventions consisting of violence prevention and education interventions that target the community and household level, combined with interventions in the education, health, and wealth-creation sectors that directly target individual girls in early adolescence. The study finds that girls exposed to such interventions progress farther in school, have greater SRH knowledge and have improved financial savings behavior—all protective factors against early pregnancy during adolescence. Such interventions, therefore, are likely to have beneficial impacts on the longer-term health and economic outcomes of girls residing in impoverished settings. The study adds to the evidence on whether and how multisectoral interventions that include adolescent-friendly services are able to reduce sex and pregnancy for girls. Future research should be carried out on understanding the impact of short-term cash-plus multisectoral interventions implemented in early adolescence on outcomes that become increasingly common in later adolescence and early adulthood, such as contraceptive use, secondary school completion and income generation.

Supporting information

S1 Table. Key indicators for AGI-K primary and secondary outcomes.

(DOCX)

S2 Table. Baseline means for full baseline sample, by study arm.

(DOCX)

S3 Table. Baseline correlates of endline survey response, by study arm.

(DOCX)

S4 Table. Additional estimated ITT effects on primary outcomes at endline, by study arm.

(DOCX)

S5 Table. Additional estimated ITT effects on secondary outcomes summary measures at endline, by study arm.

(DOCX)

S6 Table. Estimated ITT effects on individual components of secondary outcomes at endline, by study arm.

(DOCX)

S7 Table. Endline outcome variable definitions.

(DOCX)

S1 Text. Note on attrition weight construction and baseline correlates of endline survey response, by study arm.

(DOCX)

S2 Text. HSV-2 testing procedures.

(DOCX)

S1 File

(DOCX)

S2 File. CONSORT 2010 checklist of information to include when reporting a randomised trial*.

(DOC)

S3 File

(DOCX)

Acknowledgments

The authors thank our implementing partners at Plan International in Kenya for the high-quality program implementation and strict adherence to the study protocols. We also thank Elizabeth Friesen who provided excellent assistance with data preparation, as well as Population Council staff and data enumerators for implementing data collection. We gratefully acknowledge the efforts of others who contributed to the development of the study design and research instruments, including Eunice Muthengi, Caroline Kabiru, and Joyce Mumah. Finally, we thank all of the adolescent girls and their households who agreed to participate in this study and share their information with us. We also thank Rebecca Balasa, Joyce Wamoyi, and an anonymous referee for valuable comments. All errors and omissions are our own.

Data Availability

All data files are currently available from the the HARVARD Dataverse: https://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/94U224.

Funding Statement

Awardee initials: KA Grant Number: PO6171 Funder: Foreign Commonwealth and Development Office URL:https://www.gov.uk/government/organisations/foreign-commonwealth-development-office The funder approved the trial design and provided support in the form of salaries for authors [BK, KA, ESH, NM, YDW, BA, EM, FM, JK and JAM] but did not have any additional role in study design, data collection and analysis, preparation of the manuscript or decision to publish. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Decision Letter 0

Catherine E Oldenburg

Transfer Alert

This paper was transferred from another journal. As a result, its full editorial history (including decision letters, peer reviews and author responses) may not be present.

6 May 2021

PONE-D-21-06054

Impact of a Cash Transfer and Girls Empowerment Program on Early Sexual Debut and Fertility in a Kenyan Urban Informal Settlement: Results from a Mixed-Methods Randomized Trial

PLOS ONE

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Reviewer #1: Important note: This review pertains only to ‘statistical aspects’ of the study and so ‘clinical aspects’ [like medical importance, relevance of the study, ‘clinical significance and implication(s)’ of the whole study, etc.] are to be evaluated [should be assessed] separately/independently. Further please note that any ‘statistical review’ is generally done under the assumption that (such) study specific methodological [as well as execution] issues are perfectly taken care of by the investigator(s). This review is not an exception to that and so does not cover clinical aspects {however, seldom comments are made only if those issues are intimately / scientifically related & intermingle with ‘statistical aspects’ of the study}. Agreed that ‘statistical methods’ are used as just tools here, however, they are vital part of methodology [and so should be given due importance].

COMMENTS: In my opinion the title should have been just “impact of a multisectoral program for women Empowerment” because [in ‘Methods’ section of ‘abstract’ it is clarified by saying ‘The interventions included community dialogues on the value of girls (violence prevention), a conditional cash transfer (education), weekly group meetings with health and life skills training (health), and financial literacy training and savings activities (wealth).’ which means that] “cash transfer” is just one component of women empowerment ‘program’. Therefore, the question is “Why inclusion of ‘a cash transfer’ in title?”. {‘Conclusion’ section of ‘abstract’ has no mention of “cash transfer” component of this ‘program’}. Similarly, mention of ‘early sexual debut and fertility’ in title is questionable. Moreover, please explain what exactly you intend to indicate by term ‘Mixed-Methods Randomized Trial’ in the title?

Further, I am doubtful about whether the used one can be classified as ‘a randomized trial design’ [not sure if just random allocation means you have used a randomized trial design]. I am not worried about the ‘label’, however, concerned about the ‘level of evidence’. When you say ‘Post-hoc analysis was carried out on girls who were 13-15-years-old at baseline’, do you mean that you performed ‘sub-group’ analysis on this group? Please clarify what is ‘Post-hoc analysis’. Part of the conclusion [The need to implement such interventions in early adolescence, before negative outcomes crystallize may mean that a long follow up period is necessary to be able to observe the full impact of the intervention as the girls’ transition into young adulthood] is not from this study, it may be the authors’ opinion formed from this experience. I wonder if the investigator(s) are allowed to include in conclusion lesson(s) learned from the study?

I feel that overall, though the study has potential, the ‘presentation’ is not ‘precise’ [I mean exact or to-the-point], particularly the ‘Background’ section. On page 10 (first sentence) is ‘A random sample of eligible girls was selected for the baseline survey’ which is appearing after ‘random allocation’. Is this random sample different than earlier one? How correct it is? What exactly ‘you are trying convey’? by this. Remember that this is a scientific/academic document and so all details should be clearly/correctly communicated. In the same paragraph, further you say ‘The baseline behavioral survey was conducted after public randomization and the start of the intervention.’, what do you mean by that? What do you mean by ‘the censored nature of the indicators’?

Many {such} confusing statements [example: For girls 13 years and older at baseline, we modelled HSV-2 prevalence in 2019 and incidence between 2017 and 2019 for the sample of girls testing negative in 2017] are found throughout the article (them may be correct, however, confusing for readers). Re-drafting of the complete manuscript is necessary, in my opinion. Information given regarding ‘Sample Size Calculations’ is not very clear or convincing. I guess, the Adolescent Girls Initiative-Kenya (AGI-K) is a different study (not made clear anywhere), if so, why the power of this study is quoted from that study protocol (reference 31, The quantitative study was powered to detect differences in the prevalence of first birth and number of grades attained between the V-only and each of the other three arms at endline, four years after the start of the intervention when girls in the sample would be 15–19 years old)? From the statement made that ‘The objective of this study is to assesses the program impacts on the primary outcome of delayed childbearing, as well as on a range of secondary outcomes, two years after its completion, when the girls were 15–19 years old’, it seems that this one is a program evaluation study [because if different than (AGI-K) study, will have a separate ‘power’]. Is not it the investigator’s responsibility to make that clear? Sample size per se of this study is alright (large enough), but the argument is not convincing.

Why ‘Power analysis’ was conducted for a two-sample proportions test when the study had four arms? Please refer to ‘Randomization’ section. What do mean while saying ‘High population density in urban Kibera meant it was possible to reach a large number of girls with excludable interventions, making an individual-level randomized design feasible’? Please make clear. Clarify whether AGI-K is the program name or is it (an independent) study?

In my considered opinion, there is no point in identifying / enumerating / highlighting such loopholes / confusing statements endlessly. I recommend complete redrafting of the manuscript.

Reviewer #2: Thank you for the opportunity to read and review this important research. The authors presented the results and findings of a mixed methods original research study that assessed impacts of the Adolescent Girls Initiative-Kenya (AGI-K) program on childbearing and associated outcomes, including prevalence or incidence of sexual intercourse and pregnancy. Overall, I believe that the study findings and results are interesting and informative of the effectiveness of interventions with violence prevention, education, health, and wealth creation components for adolescent girls in Kibera to pursue education and delay sexual debut. I suggest that the authors speak to the potential sexual and relational harms of focusing on delaying sexual debut and if they could also make recommendations for future research.

Background: The authors presented a relevant review of the literature and a good rationale for conducting this study. I suggest that the authors elaborate on the following: (1) why is adolescence a particularly vulnerable period for girls? (2) what are other risk factors for acquiring HSV-2 and are there other factors that compound an HSV-2-positive individual’s risk of HIV infection? (3) how are you defining or operationalizing “cash transfer” for this study? (4) how are you differentiating, if at all, transactional sex from survival sex, and what are the familial implications of this? Further, I suggest that the authors remain consistent in their use of “unintentional pregnancy”; for example, on page 6 where they refer to the cascading ramifications of pregnancy.

Methods: The authors presented the intervention context, theory, and quantitative and qualitative methods for this study. The authors have framed this as a mixed methods study; however, they have not included any information about their mixed methods study design which would inform the reader of the sequence of procedures and methods for integration. Further, I wondered why the authors focused on delayed sexual debut and questioned if focusing on sexual education and access to reproductive resources, for example, would not be more important; especially given the age of the participants, who are at an age where it is developmentally appropriate to begin sexual exploration.

Under interventions (page 8), I suggest that the authors provide further information about the process for fidelity assessment. Who was assessing fidelity and how? Was there a measure or checklist developed for this purpose?

Under randomization (page 9), further clarity regarding assignment to study arms is needed. As it is written, there is concern about allocation concealment and potentially participant and personnel blinding. I also suggest that the authors speak to which ethical considerations that were taken regarding the public assignment.

Under quantitative methodology – outcomes (page 10), I suggest that the authors elaborate on the meaning of the “censored nature” of indicators. Further, I suggest that the authors speak to why abortion (spontaneous or induced) was not measured. The authors otherwise provided an in-depth account of the quantitative methods for this study.

Under qualitative methodology (page 12), the authors mentioned that “transcripts were coded for common themes”. This is not a sufficient account of qualitative methods. I suggest that the authors further elaborate on their data collection and analysis processes.

Results: The results of this study are contextually interesting and relevant to the problem statement described. Given that the authors coded for common themes, I suggest that the authors either incorporate sub-headings identifying these themes or a table of themes found in the findings. Further, the authors should provide an integrated analysis of the quantitative results and qualitative findings throughout the results section to justify this as a mixed methods study.

Discussion: Overall, these authors presented that the participants who received all four components of the study intervention had better outcomes and that intervention effects increased with age. Given that statistical reporting was not possible for contraceptive use due to a small sub-sample, I urge the authors to comment on the potential mechanisms of this; especially given that their qualitative findings demonstrated that participants were aware of different contraceptives and where to get them. It would also suggest that the authors speak more about the theory that they engaged with in this study and how it informed their analysis and interpretation of the findings. Finally, it was particularly confusing on page 21 where the authors refer to this study as a longitudinal design for the first time. If it was a longitudinal design, the authors need to mention this in their methods section and provide further information about the different timepoints.

Reviewer #3: This study examines the long-term impact of a multi-sectoral programme on early sexual debut and fertility in an urban informal settlement in Kenya.

The paper offers interesting and useful contributions on the effects of combined and multi-sectoral interventions to address adolescent sexual and reproductive health issues. There are, however, a few minor issues that need to be addressed to improve the paper.

There is need for details on how the qualitative analysis was conducted, who conducted.

Although included parents, teachers, mentors and gate keepers were included in the qualitative sample, there are no results from these populations.

The authors might consider using more simplified statistical language for readers. For example, a marginal reduction of 0.09 SD.

There are a few grammatical checks that need to be done e.g. check for repetition page 7, intervention context.

**********

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PLoS One. 2022 Feb 7;17(2):e0262858. doi: 10.1371/journal.pone.0262858.r002

Author response to Decision Letter 0


14 Sep 2021

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Response: This has now been addressed:

The study was designed and our proposal (including primary and secondary outcomes, intervention arms, randomization design and questionnaires) submitted to and approved by 1) the Population Council Institutional Review Board (p661) and 2) the Kenyan AMREF Ethics and Scientific Review Committee (p143-2014) in 2014. In addition, research permits were obtained from the Kenyan National Commission for Science Technology and Innovation (P/18/6952/25330). Consequently, we followed all procedures required by the supporting institutions (including donors) and country where the work was implemented and the study had all required ethical approvals prior to contact with any subjects or enrollment, which began in 2015.

At the time of our approved IRB submissions in 2014, however, we were unfamiliar with the process and importance of also formally registering a non-medical trial like this elsewhere, e.g., at ISRCTN. Following the year-long effort required to initiate the study in the two sites, in late 2015 we drafted a more formal study protocol (Austrian et al. 2016) and in the process of submitting that article to BMC Public Health became aware of the need to formally register the trial for journal submission —and did so registering the unchanged trial there as well. We now make this clearer in the manuscript, under ethical approval and funding.

References:

Austrian, K., E. Muthengi, J. Mumah, E. Soler-Hampejsek, C. Kabiru, B. Abuya and J.A. Maluccio. 2016. The Adolescent Girls Initiative-Kenya (AGI-K): Study Protocol. BMC Public Health, 2016, 16:210. doi

Trial registry (assigned December 24, 2015 as part of submission process for Austrian et al. 2016). ISRCTN registry: ISRCTN77455458. https://doi.org/10.1186/ISRCTN77455458

2) Confirmation that all related trials are registered by stating: “The authors confirm that all ongoing and related trials for this drug/intervention are registered”.

Response: The phrase has been included in the ethical approval and funding section of the manuscript.

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Response: The tables have now been included as part of the manuscript and individual table files have been removed. We have also now listed the supplementary tables under “supporting information” and have uploaded each table as a separate file.

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Response: This has now been addressed. We have included the links to publicly available questionnaires and interview guides under “Supporting information”.

Link to publicly available questionnaire: https://www.popcouncil.org/uploads/pdfs/2021SBSR_AGI-K_EndlineSurveyInstruments.xlsx

Link to publicly available interview guides: https://www.popcouncil.org/uploads/pdfs/2021SBSR_AGI-K_MidlineQualInterviewGuides.pdf

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The authors have declared that no competing interests exist.

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Response: Erica Soler-Hampejsek is a self-employed independent research consultant and not associated with any commercial company. Therefore, we declare there is no commercial affiliation.

Under Financial disclosure we now indicate: “The funder approved the trial design and provided support in the form of salaries for authors [BK, KA, ESH, NM, YDW, BA, EM, FM, JK and JAM] but did not have any additional role in study design, data collection and analysis, preparation of the manuscript or decision to publish.” We have reviewed the statements relating to the author contributions and confirm that they accurately reflect the roles of the authors in the study.

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Response: As noted above, there is no commercial affiliation. We believe, therefore, that the revised funding and competing interest statements as well as information included in the cover letter are accurate.

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Response: This has now been addressed.

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Response: In our submission we indicated the figure was reproduced; more accurately, for the submitted manuscript the figure in question is a modification of Fig 1 “AGI-K Theory of Change” from Austrian et al. (2016) Open Access, available at https://bmcpublichealth.biomedcentral.com/track/pdf/10.1186/s12889-016-2888-1.pdf. Because that article is published under open access all material in it is freely reproducible as indicated on its first page. The “article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and source, provide a link to the Creative Commons license, and indicate if changes were made.”

Reference:

Austrian K, Muthengi E, Mumah J, Soler-Hampejsek E, Kabiru C, Abuya B, et al. The adolescent girls initiative-Kenya (AGI-K): study protocol. BMC public health. 2016;16(1):210. doi

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Response: Based on our comments above, this is now not applicable. Please see authors response to 8a.

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Per PLOS ONE guidelines, please explain in the methods why the trial was not prospectively registered.

Response: This has now been addressed (please see response to comment #1 above for further details). All ethical requirements for the research were completed in 2014, prior to contacting or enrolling participants. As requested, the methods section (under “Ethical Approval and Funding”) now includes the following:

“Upon completion of a draft study protocol paper in 2015, the unchanged trial was also retrospectively registered in the ISCRTN registry (ISRCTN77455458) as was required for journal submission; the authors confirm that all ongoing and related trials for this intervention are registered.”

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

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Reviewer #1: Partly

Reviewer #2: Partly

Reviewer #3: Yes

Response: We have revised the manuscript addressing all related comments by the reviewers. Please see below.________________________________________

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: Yes

Reviewer #3: Yes

Response: We have clarified further the statistical analyses in response to reviewer #1 comments. Please see below. ________________________________________

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

Response: We have now provided under “supporting information” links to publicly available questionnaires, interviewer guides and data.

________________________________________

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes

Response: We have revised the manuscript addressing all related comments by the reviewers. Please see below.________________________________________

5. Review Comments to the Author

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Reviewer #1:

1. Important note: This review pertains only to ‘statistical aspects’ of the study and so ‘clinical aspects’ [like medical importance, relevance of the study, ‘clinical significance and implication(s)’ of the whole study, etc.] are to be evaluated [should be assessed] separately/independently. Further please note that any ‘statistical review’ is generally done under the assumption that (such) study specific methodological [as well as execution] issues are perfectly taken care of by the investigator(s). This review is not an exception to that and so does not cover clinical aspects {however, seldom comments are made only if those issues are intimately / scientifically related & intermingle with ‘statistical aspects’ of the study}. Agreed that ‘statistical methods’ are used as just tools here, however, they are vital part of methodology [and so should be given due importance].

Response: Thank you for the careful attention to the statistical aspects of our submission. We are in complete agreement that statistical tools used are a vital part of the methodology and have reworked the text to make them clearer. Below we indicate how we have addressed and incorporated your comments in the substantially revised manuscript which also incorporates changes in response to the other reviewers who as you describe it focused more on the relevance of the study, i.e., clinical significance and implications.

2. COMMENTS: In my opinion the title should have been just “impact of a multisectoral program for women Empowerment” because [in ‘Methods’ section of ‘abstract’ it is clarified by saying ‘The interventions included community dialogues on the value of girls (violence prevention), a conditional cash transfer (education), weekly group meetings with health and life skills training (health), and financial literacy training and savings activities (wealth).’ which means that] “cash transfer” is just one component of women empowerment ‘program’. Therefore, the question is “Why inclusion of ‘a cash transfer’ in title?”. {‘Conclusion’ section of ‘abstract’ has no mention of “cash transfer” component of this ‘program’}. Similarly, mention of ‘early sexual debut and fertility’ in title is questionable. Moreover, please explain what exactly you intend to indicate by term ‘Mixed-Methods Randomized Trial’ in the title?

Response: We have modified the title to be:

Impacts of multisectoral cash plus programs after four years in an urban informal settlement: Adolescent Girls Initiative-Kenya (AGI-K) randomized trial

As suggested, we have modified the title to better reflect the complex nature of the interventions and have removed the “mixed-methods” designation. We continue to signal that the interventions include a cash transfer component to align with research on related programs and make the article easily accessible to those carrying out bibliographic searches for research on programs with cash transfers, particularly as these have become even more prevalent during the pandemic. As recommended, because the paper examines several important outcomes, we dropped direct mention in the title of only two of them (“early sexual debut and fertility”). Reviewer #2 also questioned whether it was appropriate to frame the study as having a “mixed-methods approach,” so we have removed that designation from the title and text. Nevertheless, we believe the qualitative research remains an important component of the evidence we provide. Consequently, we continue to report the relevant qualitative findings (which we believe complement and strengthen the statistical quantitative results) and in response to the other reviewers now more carefully describe the qualitative research design that accompanied the quantitative randomized trial.

3. Further, I am doubtful about whether the used one can be classified as ‘a randomized trial design’ [not sure if just random allocation means you have used a randomized trial design]. I am not worried about the ‘label’, however, concerned about the ‘level of evidence’. When you say ‘Post-hoc analysis was carried out on girls who were 13-15-years-old at baseline’, do you mean that you performed ‘sub-group’ analysis on this group? Please clarify what is ‘Post-hoc analysis’. Part of the conclusion [The need to implement such interventions in early adolescence, before negative outcomes crystallize may mean that a long follow up period is necessary to be able to observe the full impact of the intervention as the girls’ transition into young adulthood] is not from this study, it may be the authors’ opinion formed from this experience. I wonder if the investigator(s) are allowed to include in conclusion lesson(s) learned from the study?

Response: The AGI-K program randomly (i.e., experimentally) allocated one of four packages of interventions at the individual level to a sample of eligible girls residing in Kibera, Kenya. The study protocol was submitted to the Institutional Review Board at the Population Council and approved in 2014. We argue, therefore, that it has a randomized trial design consistent with common academic use of that concept, for example in public health and economics. Moreover, we argue that results from statistical analyses of the randomized trial provide rigorous evidence of the causal effect of each of the three packages of interventions (or study arms: VE, VEH, VEHW) compared with the V-only intervention study arm. In addition, the design permits estimation of the causal effects for three other possible comparisons (i.e., VEH vs VE, VEHW vs VE and VEHW vs VEH). (For completeness, we note in this response that we intentionally do not refer to it as a randomized controlled trial since as elaborated on in the paper it was not feasible to include a pure control group.)

Regarding “post-hoc analysis”, yes that is correct, the analysis of girls 13+ years old at baseline is a subgroup analysis. We referred to it as ‘post-hoc’ because it had not been pre-specified or outlined in the published protocol paper (Austrian et al. 2016). We now clarify that meaning and the logic for examining this subgroup, which was that 1) by virtue of being older at endline they were more likely to have begun having sex, become pregnant or given birth by the time of the survey and 2) they were the subgroup for which the additional HSV-2 measurements were taken.

Finally, we have modified the conclusions, including the highlighted statement [“The need to implement such interventions in early adolescence…”]. The current study provides evidence that the AGI-K packages of interventions affected mediating factors and delayed sexual debut for some study arms and groups. This points to the possibility that these types of interventions may be a promising approach for reducing early fertility. Even at endline in 2019, however, many girls were still only in their relatively young teens. Therefore, measurement of the cohort at older ages is needed for a full assessment of the effects of intervening in early adolescence on fertility-related outcomes for young adult females. Thus, longer-term follow-up is a priority for future research, something reviewer #2 asked us to comment on. Presently, we are seeking funding to do such follow-up.

More specifically, we conclude in the discussion section the following:

“Future research should be carried out on understanding the impact of short-term cash-plus multisectoral interventions implemented in early adolescence on outcomes that become increasingly common in later adolescence and early adulthood, such as secondary school completion, income generation and contraceptive use.”

Reference:

Austrian K, Muthengi E, Mumah J, Soler-Hampejsek E, Kabiru C, Abuya B, et al. The adolescent girls initiative-Kenya (AGI-K): study protocol. BMC public health. 2016;16(1):210. doi

4. I feel that overall, though the study has potential, the ‘presentation’ is not ‘precise’ [I mean exact or to-the-point], particularly the ‘Background’ section. On page 10 (first sentence) is ‘A random sample of eligible girls was selected for the baseline survey’ which is appearing after ‘random allocation’. Is this random sample different than earlier one? How correct it is? What exactly ‘you are trying convey’? by this. Remember that this is a scientific/academic document and so all details should be clearly/correctly communicated. In the same paragraph, further you say ‘The baseline behavioral survey was conducted after public randomization and the start of the intervention.’, what do you mean by that? What do you mean by ‘the censored nature of the indicators’?

Response: (a) We have clarified the text including removing the confusing reference to random allocation to study arm alongside sampling for the survey, which are distinct. (b) We removed the sentence beginning with “The baseline behavioral survey was conducted…” and the timing of the quantitative baseline survey is now described in the “Randomization and Data Collection” section. (c) Last, we removed the term “censored nature” which was indeed uninformative (and confusing to Reviewer #2 as well), rewriting the description of the primary outcome variables as follows:

The primary outcomes include binary 0/1 variables measured at endline and equal to one if the girl had ever: 1) had sex; 2) been pregnant; or 3) given birth.

Here we provide further explanation of (a): Because the order in which the different aspects of the study occurred and the process is crucial, we summarize them here (and have rewritten the text accordingly in “Randomization and Data Collection”). First, because there was no recent census available in the study area, we implemented a household census to identify the set of all girls living in the study area that were potentially eligible for the program. We then used this set to generate a list with only one eligible girl per household to carry out random allocation to study arms. In households with one eligible girl the girl was selected for the list. In households with more than one eligible girl, one girl was randomly selected for the list. Effectively this means allocation to study arm was at the household level since when the program began all other eligible girls in the household were invited to participate in the same study arm as the girl selected for the list.

This process yielded a list of 3,296 girls (each representing a single household) potentially eligible for the program after the initial household listing (See Figure 4); reiterating, this included exactly one girl per household. Using anonymous identification numbers we generated, these girls were then each randomly allocated to one of the four study arms in a public lottery. At this stage, however, no girls or households were contacted yet regarding the treatment status which remained concealed.

Subsequently a quantitative baseline survey was administered, prior to unblinding of study arm assignment to girls (and their households) and to the start of the program. Baseline enumerators were similarly blinded to the girl’s study arm assignment. The baseline survey targeted all girls on the list randomized to study arms, but reconfirmed eligibility prior to carrying out an interview. At a later date study arm assignment was revealed to the interviewed girl and all other eligible girls in her household, if any, were invited to participate in the program in the same study arm.

The baseline survey was conducted February–April 2015. All girls interviewed at baseline were targeted for longitudinal follow-up two years later at the end of the program (May–July 2017) and then four years later at endline (April–July 2019) (Fig 4). HSV-2 was collected for older girls (13 years old or older at baseline) in 2017 and 2019, when they were 15 years old and above.

5. Many {such} confusing statements [example: For girls 13 years and older at baseline, we modelled HSV-2 prevalence in 2019 and incidence between 2017 and 2019 for the sample of girls testing negative in 2017] are found throughout the article (them may be correct, however, confusing for readers). Re-drafting of the complete manuscript is necessary, in my opinion. Information given regarding ‘Sample Size Calculations’ is not very clear or convincing. I guess, the Adolescent Girls Initiative-Kenya (AGI-K) is a different study (not made clear anywhere), if so, why the power of this study is quoted from that study protocol (reference 31, The quantitative study was powered to detect differences in the prevalence of first birth and number of grades attained between the V-only and each of the other three arms at endline, four years after the start of the intervention when girls in the sample would be 15–19 years old)? From the statement made that ‘The objective of this study is to assesses the program impacts on the primary outcome of delayed childbearing, as well as on a range of secondary outcomes, two years after its completion, when the girls were 15–19 years old’, it seems that this one is a program evaluation study [because if different than (AGI-K) study, will have a separate ‘power’]. Is not it the investigator’s responsibility to make that clear? Sample size per se of this study is alright (large enough), but the argument is not convincing.

Response: We apologize for portions of the text that were confusing and have redrafted the manuscript for clarity, including expanding in places as necessary. Here we respond directly to your various points.

First, the paper directly analyzes the AGI-K study in Kibera, something we now clarify starting from including AGI-K in the title of the paper to avoid confusion. The AGI-K study was carried out in two distinct sites that are analyzed separately (Kibera and Wajir). AGI-K program evaluation results from Kibera are presented in the present paper and results from the other study site (Wajir) reported elsewhere (Austrian et al. 2021). Therefore, the power calculations discussed are exactly the ones done for this study. (Please see response to your comment #6 for more detail on the power analyses.)

AGI-K comprised intervention packages targeting girls 11–14 years old at baseline in 2015 and lasting for two years, i.e., from 2015 to 2017. The longitudinal endline survey was planned for, and carried out, in 2019. This was four years after the start of the AGI-K interventions (in 2015) and two years after their end (in 2017). Girls who were 11–14 years old at baseline in 2015 would be 15–18 years old at endline in 2019. Therefore, power calculations were based on outcomes for girls 15–18 at endline.

Please see the revised “Sample Size and Power Analysis” section where we have clarified the approach taken which was an assessment of minimum detectable effects (MDE) based on potential available sample size.

Regarding our prior statement: “For girls 13 years and older at baseline, we modelled HSV-2 prevalence in 2019….” We have modified the text in the “Outcomes” subsection as follows:

“We also directly examined HSV-2, an important health outcome in its own right and also valuable as an objectively measured outcome that can be used to corroborate self-reported sexual activity. Trained HIV services counsellors collected biological blood specimens via finger prick for girls 15 years old and older in 2017 and at endline in 2019 that were tested for HSV-2 (S8 Text). For the subgroup of girls with HSV-2 measurements we examined binary 0/1 variables equal to one if the girl: 1) tested positive for HSV-2 at endline (i.e., prevalence in 2019); and 2) tested positive for HSV-2 at endline having tested negative in 2017 at the two-year follow-up, indicating individuals seroconverting from negative to positive between 2017 and 2019 (i.e., incidence between 2017 and 2019).”

Reference:

Austrian K, Soler-Hampejsek E, Kangwana B, Maddox N, Diaw M, Wado Y.D, Abuya B, Muluve E, Mbushi F, Mohammed H, Aden A and Maluccio JA. Impacts of multisectoral cash plus programs on marriage and fertility after four years in pastoralist Kenya: a randomized trial. Submitted manuscript, 2021.

6. (a) Why ‘Power analysis’ was conducted for a two-sample proportions test when the study had four arms? Please refer to ‘Randomization’ section. (b) What do mean while saying ‘High population density in urban Kibera meant it was possible to reach a large number of girls with excludable interventions, making an individual-level randomized design feasible’? Please make clear. (c) Clarify whether AGI-K is the program name or is it (an independent) study?

Response:

(a) We now clarify that all the principal hypotheses outlined in the analysis plan for AGI-K in the study protocol are comparisons across two study arms at a time. Therefore, we argue the appropriate power calculations for minimum detectable effects are the two-sample tests we used.

(b) We have also rewritten/clarified the ideas underlying the statement beginning “High population density in urban Kibera….”. The text in the “Randomization and Data Collection” section now reads:

High population density and widespread availability of schools in Kibera made it possible to reach a large number of girls there with different intervention packages. For example, it was feasible to offer VE to one girl in the study area and VEH to another, inviting the second girl to participate in the health intervention girls meetings while the first was excluded from that intervention component. Therefore, we implemented an individual-level randomized design in which the unit of randomization was the girl (and her household).

(c) Regarding your last question, yes, the Adolescent Girls Initiative-Kenya (AGI-K) is the name of the program being analyzed in this paper (and not an independent or different study). We now clarify this from the outset including directly naming the program in the revised title (see our responses to your comments #2 and #5 above).

In my considered opinion, there is no point in identifying / enumerating / highlighting such loopholes / confusing statements endlessly. I recommend complete redrafting of the manuscript.

Response: Thank you for your valuable comments. We have now redrafted the entire manuscript as requested, highlighting major modifications in red and important additions to the manuscript in response to reviewer comments in green.

Reviewer #2:

1. Thank you for the opportunity to read and review this important research. The authors presented the results and findings of a mixed methods original research study that assessed impacts of the Adolescent Girls Initiative-Kenya (AGI-K) program on childbearing and associated outcomes, including prevalence or incidence of sexual intercourse and pregnancy. Overall, I believe that the study findings and results are interesting and informative of the effectiveness of interventions with violence prevention, education, health, and wealth creation components for adolescent girls in Kibera to pursue education and delay sexual debut. I suggest that the authors speak to (a) the potential sexual and relational harms of focusing on delaying sexual debut and (b) if they could also make recommendations for future research.

Response: Thank you very much for the detailed review and valuable comments allowing us to clarify confusing aspects of the manuscript and pushing us to think more carefully about our interpretations and the implications of the research. Below we respond to your comments and indicate how we have revised the manuscript to incorporate them.

(a) As we now make clearer in the theory of change, the program aimed to delay fertility in Kibera by delaying early sexual debut (intercourse) and through improved knowledges and practice of contraception and family planning, not solely through delayed sexual debut. At endline, all subjects were 18 years old or younger.

(b)

We have now added in recommendations for future research in the discussion section as follows:

“Future research should be carried out on understanding the impact of short-term cash-plus multisectoral interventions implemented in early adolescence on outcomes that become increasingly common in later adolescence and early adulthood, such as secondary school completion, income generation and contraceptive use.”

2. Background: The authors presented a relevant review of the literature and a good rationale for conducting this study. I suggest that the authors elaborate on the following: (1) why is adolescence a particularly vulnerable period for girls? (2) what are other risk factors for acquiring HSV-2 and are there other factors that compound an HSV-2-positive individual’s risk of HIV infection? (3) how are you defining or operationalizing “cash transfer” for this study? (4) how are you differentiating, if at all, transactional sex from survival sex, and what are the familial implications of this? (5) Further, I suggest that the authors remain consistent in their use of “unintentional pregnancy”; for example, on page 6 where they refer to the cascading ramifications of pregnancy.

Response:

(1) In response to your first question: The main reasons adolescence is a particularly vulnerable period is that girls undergo rapid change during those years as manifested by physical, cognitive, social, emotional and sexual development. We now explain this in the introduction and include additional relevant references.

References:

Patton GC, Sawyer SM, Santelli JS, Ross DA, Afifi R, Allen NB, Arora M, Azzopardi P, Baldwin W, Bonell C, Kakuma R, Kennedy E, Mahon J, McGovern T, Mokdad AH, Patel V, Petroni S, Reavley N, Taiwo K, Waldfogel J, Wickremarathne D, Barroso C, Bhutta Z, Fatusi AO, Mattoo A, Diers J, Fang J, Ferguson J, Ssewamala F, Viner RM. Our future: a Lancet commission on adolescent health and wellbeing. Lancet. 2016 Jun 11;387(10036):2423-78. doi: 10.1016/S0140-6736(16)00579-1. Epub 2016 May 9. PMID: 27174304; PMCID: PMC5832967.

Suleiman AB, Dahl RE. Leveraging Neuroscience to Inform Adolescent Health: The Need for an Innovative Transdisciplinary Developmental Science of Adolescence. J Adolesc Health. 2017 Mar;60(3):240-248. doi: 10.1016/j.jadohealth.2016.12.010. PMID: 28235453.

Global Accelerated Action for the Health of Adolescents (AA-HA!): guidance to support country implementation. Summary. Geneva: World Health Organization; 2017 (WHO/FWC/MCA/17.05). Licence: CC BY-NC-SA 3.0 IGO.

(2) In response to your second question: Other known risk factors for HSV-2 infection include having multiple sexual partners, having a previous history of sexually transmitted infections (STIs), and low education or socioeconomic status (Odhiambo et al., 2017; Mugo et al., 2011). Similar to HIV, the main method of HSV-2 transmission is through sexual contact, however (Johnston et al., 2016), in rare instances HSV-2 virus can be transmitted to neonates during delivery, usually resulting in neonatal death or severe disability (Corey et al., 2009; Brown et al., 1997)

In addition, HSV-2 has been shown to increase an individual’s susceptibility to HIV infection by two to three fold and transmission of HIV infection by up to five-fold (Odhiambo et al., 2017; Mugo et al., 2011) mainly through high concentrations of activated CD4 positive T cells in the genital area which are targeted by HIV and increased likelihood of breakage of the mucosal layer caused by these cells that creates an entry point for the HIV virus, both in the asymptomatic and symptomatic phase (Van de Perre et al., 2008; Gutierrez et al., 2007). Susceptibility is heightened during the symptomatic phase, through the presence of genital ulcers which are more prevalent during the first few years of infection (Van de Perre et al., 2008; Naswa et al., 2010).

We now indicate the additional risk factors for HSV-2 in the introduction and provide additional references for its links to HIV, but do not explicitly incorporate the details on risk for HIV which we do not directly study.

References:

Akinyi B, Odhiambo C, Otieno F, Inzaule S, Oswago S, Kerubo E, et al. Prevalence, incidence and correlates of HSV-2 infection in an HIV incidence adolescent and adult cohort study in western Kenya. PloS one. 2017;12(6):e0178907.

Brown ZA, Selke S, Zeh J, Kopelman J, Maslow A, Ashley RL, et al. The acquisition of herpes simplex virus during pregnancy. The New England journal of medicine. 1997;337(8):509-15.

Corey L, Wald A. Maternal and neonatal herpes simplex virus infections. The New England journal of medicine. 2009;361(14):1376-85.

Johnston C, Corey L. Current Concepts for Genital Herpes Simplex Virus Infection: Diagnostics and Pathogenesis of Genital Tract Shedding. Clinical microbiology reviews. 2016;29(1):149-61.

Mugo N, Dadabhai SS, Bunnell R, Williamson J, Bennett E, Baya I, et al. Prevalence of herpes simplex virus type 2 infection, human immunodeficiency virus/herpes simplex virus type 2 coinfection, and associated risk factors in a national, population-based survey in Kenya. Sexually transmitted diseases. 2011;38(11):1059-66.

Naswa S, Marfatia YS. Adolescent HIV/AIDS: Issues and challenges. Indian journal of sexually transmitted diseases and AIDS. 2010;31(1):1-10.

Van de Perre P, Segondy M, Foulongne V, Ouedraogo A, Konate I, Huraux JM, et al. Herpes simplex virus and HIV-1: deciphering viral synergy. The Lancet Infectious diseases. 2008;8(8):490-7

(3) In response to question three: The AGI-K program provided what are usually referred to as conditional cash transfers. These are transfers made upon completion of a specific condition, in contrast to unconditional or “no-strings-attached” cash transfers which have no conditions or co-responsibilities on the part of the beneficiary household. The transfers and related conditions are described in Figure 2. For example, the first transfer to the household per school term was made upon verification that the girl had enrolled in school for the term. In providing the conditional cash transfers, AGI-K emphasized that funds were meant to support the girl in her schooling, but actual use of the money was not monitored. Logistically, the transfers were made via electronic payments to the personal bank account of the beneficiary household. Because not all beneficiaries had bank accounts at the outset of the program, AGI-K assisted beneficiaries in opening them.

(4) In response to question four: We assessed transactional sex mainly from the qualitative data. The question posed to girls as well as other stakeholders regarding sexual behavior was “can you describe the different types of romantic/ sexual relationships that girls may have and the motivations for that relationship?” The responses indicated that motivations for girls engaging in sex included money, gifts and peer and media influence. We define transactional sex to mean having sex in anticipation of or actual exchange for money or gifts but are unable to go further and differentiate between transactional sex and survival sex for this young cohort. We did not analyze transactional sex using the quantitative data.

The qualitative data suggest that some parents are aware of their daughters engaging in sexual relationships in exchange for money and gifts but do not address it because they benefit indirectly from the receipt of the money or gifts. However, it is not clear from the data how common this practice might be.

(5) In response to question five: Our paper examines “early pregnancy” without trying to separate out or directly examine “unintended” pregnancies. Hence, we have corrected our inconsistent and confusing use of the concept of “unintended pregnancy” by removing reference to it when discussing our hypotheses and analyses but continue to use it when referring to other literature that does directly address it.

We note that one reason for not directly analyzing unintended pregnancies is that it is difficult to reliably gather information about them. The survey did ask those who were currently pregnant “At the time you became pregnant, did you want to become pregnant then, did you want to wait until later, or did you not want the pregnancy at all?” In 2019 for N=43 responding, 28% indicated they had wanted the pregnancy then, 30% indicated later and 42% indicated not at all.

3. Methods: The authors presented the intervention context, theory, and quantitative and qualitative methods for this study. (a) The authors have framed this as a mixed methods study; however, they have not included any information about their mixed methods study design which would inform the reader of the sequence of procedures and methods for integration. (b) Further, I wondered why the authors focused on delayed sexual debut and questioned if focusing on sexual education and access to reproductive resources, for example, would not be more important; especially given the age of the participants, who are at an age where it is developmentally appropriate to begin sexual exploration.

Response:

(a) Reviewer #1 also queried whether it was appropriate to frame the study as having a “mixed-methods approach,” so we have removed that designation from the title and text. Nevertheless, we believe the qualitative research remains an important component of the overall evidence we provide. Consequently, we continue to report the relevant qualitative findings (which we believe complement and strengthen the statistical quantitative results) and in response to your comments and those of Reviewer #3 now more fully describe the qualitative research design that accompanied the quantitative randomized trial.

(b) Based on our theory of change we hypothesize that the education on health and life skills received through the girls’ groups will increase knowledge on sexual and reproductive health (SRH) which will in turn result in delayed sexual debut and increased FP use. Two years into the implementation of the interventions there was a significant increase in sexual and reproductive knowledge for girls who received the health component of the intervention. This has been documented in a paper examining the effects of the program after two years (Austrian et al., 2021). Four years after the implementation of the intervention we continue to observe improved SRH knowledge as well as some evidence of delayed sexual debut. We go further to recommend future research be carried out to understand the impact of this and other similar short-term interventions on girls as they transition into adulthood, including the impact of such an intervention on use of contraception, as more girls become sexually active.

Reference:

Austrian, K., Soler-Hampejsek E, Kangwana B, Wado Y.D, Abuya B and Maluccio J.A. Impacts of two-year multisectoral cash plus programs on young adolescent girls’ education, health and economic outcomes: Adolescent Girls Initiative-Kenya (AGI-K) randomized trial. 2021 submitted manuscript.

4. Under interventions (page 8), I suggest that the authors provide further information about the process for fidelity assessment. Who was assessing fidelity and how? Was there a measure or checklist developed for this purpose?

Response: We have now included a description of the processes, which included an electronic monitoring database for program activities (fulfillment of conditions by girls, all transfers, details of all girls group meetings held) as well as monitoring of the mentors and their groups. Please see “Interventions” section.

5. Under randomization (page 9), (a) further clarity regarding assignment to study arms is needed. As it is written, there is concern about allocation concealment and potentially participant and personnel blinding. (b) I also suggest that the authors speak to which ethical considerations that were taken regarding the public assignment.

Response: (a) We have reworked the section on “Randomization and Data Collection” to improve clarity. Given the nature of the interventions it was of course not possible during program implementation for participants or NGO implementing personnel to be blinded to the study arm of an individual girl once the intervention began. The random allocation, however, was not known to enumerators or beneficiaries (i.e., it was still concealed) at the time of the baseline survey. During the two-year follow-up survey (analyzed in a separate paper, Austrian et al. 2021) there were questions about the program at the end of the survey so at that stage in the interview enumerators would become aware of the study arm based on skip patterns (for example, questions about girls group meetings were asked only of those in VEH or VEHW study arms). These questions were not asked in the endline survey, however, making it less likely enumerators would have been aware of the previously assigned study arm for the program that had ended two years earlier.

(b) Ethical considerations of public assignment: We outline ethical approval for the randomized trial in the section “Ethical Approval and Funding.” The principal ethical justification for carrying out the randomized trial with different beneficiaries receiving different packages of interventions was to estimate the unknown marginal benefit as each single-sector intervention was added to the package relative to the V-only intervention. In this situation of equipoise randomization was justified. For community acceptance of the research intervention, it was important to do the allocation in a transparent manner with community stakeholders present, so randomization was done publicly, directed by the Population Council. First, the four interventions and study arms were described after which the procedure for randomization detailed and then carried out and formally recorded with the Population Council until beneficiaries were notified at a later date.

Reference:

Austrian, K., E. Soler-Hampejsek, B. Kangwana, Y.D. Wado, B. Abuya and J.A. Maluccio. Impacts of two-year multisectoral cash plus programs on young adolescent girls’ education, health and economic outcomes: Adolescent Girls Initiative-Kenya (AGI-K) randomized trial. 2021 submitted manuscript.

6. Under quantitative methodology – outcomes (page 10), (a) I suggest that the authors elaborate on the meaning of the “censored nature” of indicators. (b) Further, I suggest that the authors speak to why abortion (spontaneous or induced) was not measured. The authors otherwise provided an in-depth account of the quantitative methods for this study.

Response:

(a) ‘the censored nature of the indicators’: We have removed this confusing (and unnecessary) text, rewriting the description of the primary outcome variables as below:

The primary outcome measures include binary 0/1 variables measured at endline and equal to one if the girl had ever: 1) had sex; 2) been pregnant; or 3) given birth.

(b) Although abortion in Kenya is common (see below), it is illegal in most situations and therefore a particularly sensitive topic. Therefore, we did not ask about it directly, because of concern regarding the reliability of the responses about an illegal activity and the possibility of then jeopardizing full responses and cooperation with the many other questions in the survey or even leading to refusal to participate.

These other questions included multiple questions about current and prior pregnancy that give us confidence that measurement of pregnancy is accurate despite not asking directly about abortion.

In particular, in addition to asking directly about prior or current pregnancies, the survey included redundancies to accurately capture prior pregnancies. For all girls reporting they had had sex, we asked “Have you ever had a pregnancy that miscarried or ended in a stillbirth?” Consequently, our measure of pregnancy does include spontaneous abortion and possibly induced abortion depending on how the girl responded if that had been her experience. We also separately asked “Sometimes a girl becomes pregnant when she does not want to be. Have you ever been pregnant when you did not want to be?” Therefore, we have high confidence in the ever-pregnant variable.

Further background details: Abortion is common in Kenya although most of it is illegal. Estimates from 2002 indicate the abortion rate (abortions per 1000 women of childbearing age) was 46 and the abortion ratio (abortions per 100 pregnancies) was 26 (Guttmacher 2012). Induced abortion in Kenya is illegal in most situations, but is legal in cases in which the mother’s health or life is at risk since 2010. Prior to that it had been legal only to save the mother’s life.

The 2014 Kenya Demographic and Health Survey (KDHS) does ask directly about induced abortion, including it as an addition to the question we asked: “Have you ever had a pregnancy that miscarried, was aborted, or ended in stillbirth?” Authors analysis of KDHS indicates that in the Nairobi region <3% of females aged 15–19 responded yes to this question; this was the same percent responding yes to the similar question we included in AGI-K, further bolstering confidence in our measurement of pregnancy.

These low percentages also underscore that it would have been difficult to directly study induced abortion in this population-based survey. To measure abortion different sampling approaches are usually employed, such as sampling among women presenting for abortion services (Kabiru et al. 2016).

References:

Guttmacher Institute. Abortion and unintended pregnancy in Kenya. Series 2012, No.2

Kabiru, C.W., B.A. Ushie, M.M. Mutua and C.O. Izugbara. Previous induced abortion among young women seeking abortion-related care in Kenya: A cross-sectional analysis. 2016. BMC Pregnancy and Childbirth 16:104.

6. Under qualitative methodology (page 12), the authors mentioned that “transcripts were coded for common themes”. This is not a sufficient account of qualitative methods. I suggest that the authors further elaborate on their data collection and analysis processes.

Response: Agreed. This was an important omission in our first submission also commented on by Reviewer #3. We now fully describe the data collection (in the “Randomization and Data Collection) and analysis processes (in the “Qualitative Methodology”) section.

7. Results: The results of this study are contextually interesting and relevant to the problem statement described. Given that the authors coded for common themes, I suggest that the authors either incorporate sub-headings identifying these themes or a table of themes found in the findings. Further, the authors should provide an integrated analysis of the quantitative results and qualitative findings throughout the results section to justify this as a mixed methods study.

Response: As recommended, we have incorporated sub-headings reflecting common themes from the qualitative results. As indicated above in our response to your Comment #3, we no longer define this as a “mixed-methods” study but instead are using findings from the qualitative data collection to help explain the quantitative findings. In the results section, therefore, we have presented the relevant qualitative findings next to the quantitative findings. We then proceed to integrate the quantitative and qualitative findings in the discussion.

8. Discussion: Overall, these authors presented that the participants who received all four components of the study intervention had better outcomes and that intervention effects increased with age. Given that statistical reporting was not possible for contraceptive use due to a small sub-sample, I urge the authors to comment on the potential mechanisms of this; especially given that their qualitative findings demonstrated that participants were aware of different contraceptives and where to get them. It would also suggest that the authors speak more about the theory that they engaged with in this study and how it informed their analysis and interpretation of the findings. Finally, it was particularly confusing on page 21 where the authors refer to this study as a longitudinal design for the first time. If it was a longitudinal design, the authors need to mention this in their methods section and provide further information about the different timepoints.

Response: We have now added into the discussion the potential mechanisms in which the intervention was hypothesized to have an impact on contraceptive use (paragraphs 3 and 8 of the discussion section). We also expanded the explanation of how our method of analysis and results relate to the study's proposed theory of change.

Last, we apologize for the confusion regarding the longitudinal design. We now clarify in both the abstract and the data description that this is a (prospective) longitudinal study.  

Reviewer #3:

1. This study examines the long-term impact of a multi-sectoral programme on early sexual debut and fertility in an urban informal settlement in Kenya. The paper offers interesting and useful contributions on the effects of combined and multi-sectoral interventions to address adolescent sexual and reproductive health issues. There are, however, a few minor issues that need to be addressed to improve the paper.

Response: Thank you for the positive assessment of our paper – please see above (and in the manuscript) how we addressed your comments.

2. There is need for details on how the qualitative analysis was conducted, who conducted.

Response: Agreed. This was an important omission in our first submission also commented on by Reviewer #2. We now fully describe the data collection (in the “Randomization and Data Collection) and analysis processes (in the “Qualitative Methodology”) section.

3. Although included parents, teachers, mentors and gate keepers were included in the qualitative sample, there are no results from these populations.

Response: Although the qualitative results section does not include direct quotes from every single type of respondent, responses reported by all respondents are reflected/summarized in the presentation of the results and discussion.

4. The authors might consider using more simplified statistical language for readers. For example, a marginal reduction of 0.09 SD.

Response: We have modified the referenced statement and others like it throughout the text. In particular, we replaced the term “marginally significant” with more direct mention of significance level (e.g., 10% significance) when appropriate. For the summary z-score measures the coefficient estimates all reflect changes in standard deviations (SD) in the summary measure so this was not altered but is now spelled out better in the quantitative methodology section.

5. There are a few grammatical checks that need to be done e.g. check for repetition page 7, intervention context.

Response: We have copy edited the entire manuscript, including page 7 repetition regarding the intervention context.

________________________________________

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Response: We are ok for the peer reviewed history of this article to be published in full.

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Reviewer #1: No

Reviewer #2: Yes: Rebecca Balasa

Reviewer #3: Yes: Joyce Wamoyi

Attachment

Submitted filename: Response to Reviewers August2021_Final.docx

Decision Letter 1

Catherine E Oldenburg

26 Oct 2021

PONE-D-21-06054R1Impacts of multisectoral cash plus programs after four years in an urban informal settlement: Adolescent Girls Initiative-Kenya (AGI-K) randomized trialPLOS ONE

Dear Dr. Kangwana,

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6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Although there is some improvement in manuscript after revision, still there are many confusing statements and as said earlier the ‘presentation’ is not ‘precise’, to-the-point. Please check the English language [professional intervention may be needed, I guess]. I have no specific recommendation(s) and think that, ‘let the respected editor decide the future course’.

Reviewer #2: Thank you to the authors for their in-depth responses to reviewer comments and for revising this manuscript accordingly. My remaining major recommendations are as follows: (1) the authors speak to transactional sex in the background and prostitution in their findings. As it is written, the authors seem to be overlooking that children and youth cannot consent to sex work. Instead of reporting that girls in their sample engaged in prostitution, I would recommend writing that they have experience child sexual exploitation. If the context and laws in Kenya suggest otherwise, I strongly recommend that the authors highlight this; and (2) the section describing qualitative methodology and methods is still insufficient. The authors reported using grounded theory; however, their study is deductive from the Theory of Change and they have not reported nor demonstrated that this study is seeking to develop a theory. Furthermore, information regarding the methods to support a grounded theory methodology is missing. I would recommend that the authors provide further information regarding data collection (who conducted the interviews and focus groups? How were these conducted?) and data analysis (how was the analysis iterative? How did the authors analyze within and across themes or categories? Did the authors employ axial coding?). I would also suggest that the authors explain how and why the interviews were validated and reviewed for quality assurance. Lastly, I would suggest that the authors provide a qualitative research question and sub-questions (if relevant). Please find further minor recommendations below.

Abstract: Under methods, I would suggest rewording “the value of girls” for the violence prevention outcome.

Background: Thank you for expanding on the importance of adolescent development. I would suggest reframing that this developmental stage is inherently vulnerable to instead underscore the reasons for vulnerability that you’ve identified in the second sentence of your second paragraph (“lack of economic security, unequal gender norms, pressure from peers to engage in sexual activity, pressure from families to achieve economic security through early marriage, and not living with one’s parents”). I would also recommend rewording or contextualizing the “cascading ramifications of pregnancy” in this section.

Methods: As indicated above, I strongly suggest that the authors revise their qualitative methodology section. In addition, I would recommend that the authors provide an account of the theoretical underpinnings of the Theory of Change that is guiding this study. I also wonder if the authors would not consider reframing the qualitative component of this study as a qualitative evaluation of the trial – this reframing would seem to be appropriate given the aims of the qualitative exploration that they have identified.

Ethical considerations: Can the authors please provide an explanation for why parental assent was required for participants between 12-18 years of age?

Results: I would suggest that the authors begin the results section with an account of their participants’ demographic information and sample sizes. Although the participants provided further context for their qualitative findings, there are few quotes included to support the analysis; this may be due to limited space. I would therefore recommend that the authors include a table of qualitative findings, including themes and participant quotes. In Table 2, results for a measured cognitive score are presented – can the authors please speak to the purpose of this measure for the study. I also wondered why participants in the V-only arm did not receive transfers and ask that the authors briefly provide an explanation for this. Lastly, I would strongly recommend that the authors revise the language used to explain that girls learned to “protect themselves from boys and against violence”, as this wording currently places the responsibility of experiences of violence on girls.

**********

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Reviewer #1: No

Reviewer #2: No

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PLoS One. 2022 Feb 7;17(2):e0262858. doi: 10.1371/journal.pone.0262858.r004

Author response to Decision Letter 1


15 Dec 2021

Author response to second round of reviews for PONE-D-21-06054R1

We thank the reviewers for the additional valuable comments and have redrafted the paper to address them.

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Response: We have reviewed all the references and made some amendments to ensure that they are accurately presented. Please let us know if there are any specific reference you feel need further attention.

Due to the changes we have made as a result of suggestions made by the reviewers, we have retracted one reference: Strauss, A. and J. Corbin. 1998. Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory. Thousand Oaks, CA: Sage Publications.

Reviewer #1: Although there is some improvement in manuscript after revision, still there are many confusing statements and as said earlier the ‘presentation’ is not ‘precise’, to-the-point. Please check the English language [professional intervention may be needed, I guess]. I have no specific recommendation(s) and think that, ‘let the respected editor decide the future course’.

Response: After incorporating material and reworking to address Reviewer #2’s comments we 1) reviewed and edited the entire manuscript ourselves and then 2) had it reviewed and edited by the team in the Population Council Inc Knowledge Communications office.

Reviewer #2: Thank you to the authors for their in-depth responses to reviewer comments and for revising this manuscript accordingly. My remaining major recommendations are as follows: (1) the authors speak to transactional sex in the background and prostitution in their findings. As it is written, the authors seem to be overlooking that children and youth cannot consent to sex work. Instead of reporting that girls in their sample engaged in prostitution, I would recommend writing that they have experience child sexual exploitation. If the context and laws in Kenya suggest otherwise, I strongly recommend that the authors highlight this;...

Response: Thank you for this suggestion. We agree with the reviewer and in line with their suggestion have replaced ‘transactional sex’ in the background and ‘prostitution’ in the findings section with child sexual exploitation.

...and (2) the section describing qualitative methodology and methods is still insufficient. The authors reported using grounded theory; however, their study is deductive from the Theory of Change and they have not reported nor demonstrated that this study is seeking to develop a theory. Furthermore, information regarding the methods to support a grounded theory methodology is missing.

Response: Thank you for this comment. We have re-framed the description of the qualitative component as a qualitative evaluation of the trial and clarified the description of the approach to the analysis that was undertaken.

I would recommend that the authors provide further information regarding data collection (who conducted the interviews and focus groups? How were these conducted?) and data analysis (how was the analysis iterative? How did the authors analyze within and across themes or categories? Did the authors employ axial coding?). I would also suggest that the authors explain how and why the interviews were validated and reviewed for quality assurance. Lastly, I would suggest that the authors provide a qualitative research question and sub-questions (if relevant). Please find further minor recommendations below.

Response: We have incorporated the additional details regarding the qualitative data collection in the qualitative methodology section. All interviews were conducted by trained interviewers and moderators. The analyses consisted firstly of developing a start-list of codes that were derived from the program’s Theory of Change as well as from the interview guides. Further themes were added as they emerged from reviewing the data. To ensure quality assurance, all transcripts were double coded by two qualified analysts. All double-coded transcripts underwent testing for intercoder agreement and where the Krippendorff’s c-α-binary coefficient was below 0.70, a side-by-side comparison, clarification and reconciliation was carried out on the specific coded transcripts.

Abstract: Under methods, I would suggest rewording “the value of girls” for the violence prevention outcome.

Response: Thank you for this suggestion. We have now rephrased “the value of girls” to “unequal gender norms and their consequences” which we feel is a more accurate reflection of what was discussed in the community dialogues.

Background: Thank you for expanding on the importance of adolescent development. I would suggest reframing that this developmental stage is inherently vulnerable to instead underscore the reasons for vulnerability that you’ve identified in the second sentence of your second paragraph (“lack of economic security, unequal gender norms, pressure from peers to engage in sexual activity, pressure from families to achieve economic security through early marriage, and not living with one’s parents”). I would also recommend rewording or contextualizing the “cascading ramifications of pregnancy” in this section.

Response: We have modified the first paragraph so that it more clearly describes how developmental changes that occur during adolescence, in combination with certain negative external factors, increase the risk of early pregnancy. We have in addition changed the phrase “cascading ramifications of pregnancy” to “negative potential consequences of pregnancies.”

Methods: As indicated above, I strongly suggest that the authors revise their qualitative methodology section. In addition, I would recommend that the authors provide an account of the theoretical underpinnings of the Theory of Change that is guiding this study.

Response: We have made revisions to the qualitative methodology section. In addition, we now reference the theories used to develop the original AGI-K theory of change and provide relevant citations.

I also wonder if the authors would not consider reframing the qualitative component of this study as a qualitative evaluation of the trial – this reframing would seem to be appropriate given the aims of the qualitative exploration that they have identified.

Response: Thank you for this suggestion, we agree this is a better characterization of the work. We have made the changes to the ‘Randomization and Data Collection’ and ‘Qualitative Methodology’ sections to indicate that the qualitative component of the study was indeed a qualitative evaluation of the program.

Ethical considerations: Can the authors please provide an explanation for why parental assent was required for participants between 12-18 years of age?

Response: Our description was unclear, and we have edited it. Written informed consent was required from all girls 18 years old or older. For girls under 18 years old, written informed consent was required from a parent or guardian, and oral assent from the girl herself.

Results: I would suggest that the authors begin the results section with an account of their participants’ demographic information and sample sizes. Although the participants provided further context for their qualitative findings, there are few quotes included to support the analysis; this may be due to limited space. I would therefore recommend that the authors include a table of qualitative findings, including themes and participant quotes.

Response: We have added in a section on participants’ demographic information and sample sizes at the beginning of the qualitative results section. Moreover, we include a table to display the socio-demographic characteristics of the participants that were interviewed for the qualitative evaluation (Table 5). Additional quotes have been incorporated into the qualitative findings section.

In Table 2, results for a measured cognitive score are presented – can the authors please speak to the purpose of this measure for the study.

Response: Because an important secondary outcome in the study was education, we measured cognitive scores to enable careful assessment of baseline balance on an important indicator associated with schooling advancement. The cognitive score measure is used as a control in the extended controls models to increase precision of the estimates. The theory of change did not posit that the intervention would strongly influence cognitive scores, so it was measured only at baseline.

I also wondered why participants in the V-only arm did not receive transfers and ask that the authors briefly provide an explanation for this.

Response: An objective of the study was to provide rigorous evidence on the causal impacts of providing the three different packages of interventions (all with the education component) against a comparison group. To do so, we used a randomized trial research design in which girls were randomly allocated to four different study arms, including a study arm without the education, health or wealth interventions to be used as the experimental comparison in the quantitative analyses.

Lastly, I would strongly recommend that the authors revise the language used to explain that girls learned to “protect themselves from boys and against violence”, as this wording currently places the responsibility of experiences of violence on girls.

Response: Thank you for this suggestion. We have amended the phrase “protect themselves from boys and against violence” to “recognize and protect themselves from sexual and gender-based violence”

Attachment

Submitted filename: Author response to reviews for PONE 10thDec2021.docx

Decision Letter 2

Catherine E Oldenburg

7 Jan 2022

Impacts of multisectoral cash plus programs after four years in an urban informal settlement: Adolescent Girls Initiative-Kenya (AGI-K) randomized trial

PONE-D-21-06054R2

Dear Dr. Kangwana,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Catherine E Oldenburg

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Acceptance letter

Catherine E Oldenburg

21 Jan 2022

PONE-D-21-06054R2

Impacts of multisectoral cash plus programs after four years in an urban informal settlement: Adolescent Girls Initiative-Kenya (AGI-K) randomized trial

Dear Dr. Kangwana:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Catherine E Oldenburg

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 Table. Key indicators for AGI-K primary and secondary outcomes.

    (DOCX)

    S2 Table. Baseline means for full baseline sample, by study arm.

    (DOCX)

    S3 Table. Baseline correlates of endline survey response, by study arm.

    (DOCX)

    S4 Table. Additional estimated ITT effects on primary outcomes at endline, by study arm.

    (DOCX)

    S5 Table. Additional estimated ITT effects on secondary outcomes summary measures at endline, by study arm.

    (DOCX)

    S6 Table. Estimated ITT effects on individual components of secondary outcomes at endline, by study arm.

    (DOCX)

    S7 Table. Endline outcome variable definitions.

    (DOCX)

    S1 Text. Note on attrition weight construction and baseline correlates of endline survey response, by study arm.

    (DOCX)

    S2 Text. HSV-2 testing procedures.

    (DOCX)

    S1 File

    (DOCX)

    S2 File. CONSORT 2010 checklist of information to include when reporting a randomised trial*.

    (DOC)

    S3 File

    (DOCX)

    Attachment

    Submitted filename: renamed_567d5.docx

    Attachment

    Submitted filename: Response to Reviewers August2021_Final.docx

    Attachment

    Submitted filename: Author response to reviews for PONE 10thDec2021.docx

    Data Availability Statement

    All data files are currently available from the the HARVARD Dataverse: https://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/94U224.


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