Abstract
Objectives
We evaluated the causal effects of high-risk versus low-risk pregnancy at the first antenatal care (ANC) visit on the occurrence of complications during pregnancy and labour or delivery among women in Kenya.
Methods
We designed a quasi-experimental study using observational data from a large mobile health wallet programme, with the exposure as pregnancy risk at the first ANC visit, measured on a binary scale (low vs high). Complications during pregnancy and at labour or delivery were the study outcomes on a binary scale (yes vs no). Causal effects of the exposure were examined using a double-robust estimation, reported as an OR with a 95% CI.
Results
We studied 4419 women aged 10–49 years (mean, 25.6±6.27 years), with the majority aged 20–29 years (53.4%) and rural residents (87.4%). Of 3271 women with low-risk pregnancy at the first ANC visit, 833 (25.5%) had complications during pregnancy while 1074 (32.8%) had complications at labour/delivery. Conversely, of 1148 women with high-risk pregnancy at the first ANC visit, 343 (29.9%) had complication during pregnancy while 488 (42.5%) had complications at labour delivery. Multivariable adjusted analysis showed that women with high-risk pregnancy at the time of first ANC attendance had a higher occurrence of complications during pregnancy (adjusted OR (aOR) 1.22, 95% CI 1.02 to 1.46) and labour or delivery (aOR 1.20, 95% CI 1.03 to 1.41). In the double-robust estimation, a high-risk pregnancy at first ANC visit increased the occurrence of complications during pregnancy (OR 1.23, 95% CI 1.04 to 1.46) and labour or delivery (OR 1.24, 95% CI 1.07 to 1.45).
Conclusion
Women with a high-risk pregnancy at the first ANC visit have an increased occurrence of complications during pregnancy and labour or delivery. These women should be identified early for close and appropriate obstetric and intrapartum monitoring and care to ensure maternal and neonatal survival.
Keywords: Antenatal, Risk management, Maternal medicine, NEONATOLOGY
Strengths and limitations of this study.
Large sample size with adequate statistical power to detect small effect sizes.
Use of rigorous quasi-experimental design and robust analytical approach to estimate causal effects.
Findings are generalisable due to the use of real-world observational data.
Lack of data on postpartum complications limits analysis of the full impact of high-risk pregnancy.
Unmeasured confounders not accounted for due to the use of secondary data.
Introduction
High-risk pregnancies account for a substantial proportion of maternal deaths globally, with haemorrhage, sepsis, unsafe abortion or pre-eclampsia accounting for more than 99% of maternal deaths in low-income and middle-income countries.1 2 Every pregnancy carries a significant risk for complications, which is largely preventable. Complications may exist before pregnancy but then get worse during pregnancy, especially if not well managed by healthcare providers.3 4 A high-risk pregnancy might be indicative of underlying health conditions like diabetes mellitus or hypertension,3 4 including a lack of access to or usage of antenatal care (ANC) leading to inadequate management of potential complications during pregnancy, labour or delivery.4 5 Women in sub-Saharan Africa face huge pregnancy and delivery-related complications, with under half (46.5%) of the births attended by skilled health professionals.6 Despite several decades of maternal health interventions, pregnancy-related complications remain a leading cause of maternal morbidity and mortality in sub-Saharan Africa.4 5 In many low-income and middle-income countries, including Kenya, high rates of pregnancy complications persist, even when skilled professionals attend the birth, often due to subpar care quality. Kenya has adopted the WHO goal-oriented ANC package and designed new guidelines focusing on ANC, birth preparedness for emergencies, diagnosis, and treatment of life-threatening conditions during the antenatal and perinatal period,7 which include high-risk pregnancies. Women who have risky pregnancy (low or high) receive the standard ANC package per the Kenya national guidelines, for example, additional laboratory tests, more frequent ANC visits and referral to higher-level facilities among others. ANC attendance might mitigate pregnancy-related complications by providing opportunities for early detection of risks and other underlying illnesses and ensuring early intervention but the visits are mostly infrequent and untimely.5 8 Identifying pregnancies as high-risk early during ANC has the potential to prevent complications that could occur later during pregnancy, labour or delivery.9
Evidence from previous studies shows that high-risk pregnancies are associated with high levels of depression and anxiety; so require periodic screening and psychosocial support.10 Findings from a meta-synthesis of several studies indicate that women with high-risk pregnancies depend on several sources of information to determine their risk status and tend to underestimate the hazards of the risk despite being aware.11 One study reports that pregnancy outcomes among women with a high-risk pregnancy, especially advanced age impact negatively their health for reasons: changes during pregnancy and an increased risk for pregnancy-related complications.12 Another study shows that nearly 3 in 10 high-risk pregnancies have adverse fetal outcomes.13
Whereas there is sufficient evidence regarding the factors associated with high-risk pregnancy and its association with maternal mortality, the effects of a high-risk pregnancy at the first ANC visit or baseline on the occurrence of complications during pregnancy, and labour or delivery has not been rigorously evaluated in several low-income and middle-income countries. We evaluated the causal effects of high-risk versus low-risk pregnancy at the first ANC visit on the occurrence of complications during pregnancy and labour or delivery among women in Kenya.
Methods and materials
Study setting and data source
This study was conducted in Kisumu and Kakamega counties in western Kenya using data from a subsidised mobile health wallet programme implemented by PharmAccess Foundation International in Kenya. The programme provided maternity care to pregnant women in Kisumu and Kakamega counties, with enrolment starting at 16 weeks of gestation but without exclusion of high-risk groups such as teenage pregnant women and women living with HIV. The programme targeted pregnant women aged 15–49 years within Kisumu and Kakamega counties. Launched in 2019, the programme aimed to address preventable maternal and newborn deaths in the two counties through a subsidised mobile health wallet intervention that supports pregnant women and healthcare providers of maternity care. The programme entitled pregnant women in the counties to a care bundle, an alternate model for healthcare designed to improve patient outcomes and quality of care, for antenatal, delivery and postnatal care (PNC) at designated facilities within the counties. The programme provides nudges, reminders for checkups and rewards to improve commitment on the side of the patient.
Mothers were enrolled in a partly subsidised health insurance programme and used a mobile platform at a service provider that included the following care bundles: four ANC consultations, antenatal profiles test, one ultrasound, iron, folate supplement, delivery, PNC consultation and immunisation for the newborns among others. On the healthcare provider side, the programme provided financial compensation for the airtime required to make the phone calls but rather received a payment in the form of a bonus conditional on women completing their full pregnancy journey. By digitalising maternal experience via mobile phone, ANC visits and experiences were tracked over time, with market failures and fragmented funding in the health sector addressed in real-time. At each ANC visit, mothers and healthcare providers agreed on the entire care continuum for a condition or medical event. Data were collected during each visit and used to assist healthcare providers to track maternal and fetal conditions and continuously improve the quality of ANC services.
At the first ANC, the women received several tests: a full blood count, syphilis using the Veneral Disease Research Laboratory test and confirmation using the Treponema Pallidum Haemoagglutination test, blood grouping, and cross-matching, haemoglobin level estimation, HIV test, urine analysis and hepatitis B surface antigen test. They were also screened for tuberculosis (TB) using intensified TB screening guide. In the subsequent visits, some of the tests were repeated per the Kenya Ministry of Health ANC guidelines.
The programme collected data on pregnancy risks at the first and subsequent ANC visits, including complication risks at the time of labour or delivery. Mothers were assigned a system-generated risk level at the first ANC based on the data collected as either low-risk or high-risk pregnancy. The risk classification was done automatically based on an algorithm that analysed the data entered by healthcare providers concerning the medical history, and the results of the clinical tests among others. During the pregnancy journey and based on the obstetric risks identified, a new risk level was assigned or the previous risk level was maintained depending on the patterns of the risk mitigation plan. Overall, the data analysed in this study are for pregnant aged 10–49 years enrolled in the mobile health wallet programme, who had sought maternal and child healthcare at 16 health facilities (3 Kakamega and 13 Kisumu) between January 2020 and December 2020.
Study design
We designed a non-randomised, quasi-experimental study using observational data retrieved from the mobile health wallet programme. The causal effects of interventions are best examined in a randomised controlled trial as randomisation achieves comparability in both measured and unmeasured baseline characteristics between the intervention and control groups, except for the intervention.14 15 However, a randomised experiment is not feasible using observational data and is not ethical for harmful exposures or when the potential benefits of the exposures are known. Under such circumstances, quasi-experimental designs offer an alternative approach to measuring causal effects.16 17 However, quasi-experimental studies are limited due to a lack of comparability in participant characteristics between the exposed and unexposed groups (selection bias), and the confounding of the exposure–outcome relationship by factors that influence both the exposure and the outcome. These limitations have to be excluded when measuring the causal effects of an exposure using statistical methods for causal inference and cause-effect estimation.
Measurements
Exposure
The exposure of interest was pregnancy risk at the first ANC visit measured on a binary scale (low vs high) by health workers, using either a self-report, review of previous records (medical, surgical, and obstetric and gynaecological among others), laboratory examination or anthropometric measurements. Women with any one of the following conditions were considered to have a high-risk pregnancy: (1) pre-existing medical conditions, namely high blood pressure (hypertension), diabetes mellitus, HIV, TB, hepatitis B infection and moderate/severe anaemia; (2) overweight and obesity: obesity increases the risk for high blood pressure, pre-eclampsia, gestational diabetes, stillbirth, neural tube defects and caesarean delivery; (3) multiple fetuses: the risk of complications is higher in women carrying more than one fetus (twins and higher-order multiples) compared with those carrying a single fetus. Common complications associated with multiple births include pre-eclampsia, premature labour and preterm birth. Data show that more than one-half of all twins and as many as 93% of triplets are born at less than 37 weeks gestation; (4) younger (below or equals 19 years) or older maternal age (≥35 years). Studies show that pregnancy in teens and at ≥35 years increases the risk for pre-eclampsia and gestational high blood pressure; and (5) history of caesarean section and all the rest were considered as low-risk pregnancies. Women with a high-risk pregnancy formed the exposed group while the unexposed group was women with a low-risk pregnancy.
Outcomes
The primary outcome was the occurrence of complications during pregnancy, measured on a binary scale (yes vs no) after the first ANC visit. Women who had experienced anyone of the following conditions were considered to have a complication during pregnancy otherwise none: antepartum haemorrhage caused by placenta abruption or placenta previa, pre-eclampsia, septicaemia, abortion or preterm delivery, and stillbirth. The secondary outcome was the occurrence of complications at labour or delivery, measured on a binary scale (no vs yes). Women who had experienced excessive bleeding within 6 hours following delivery (primary postpartum haemorrhage), premature rupture of membranes, umbilical cord prolapse, fetal distress, abnormal fetal heart rate, perineal tears, and shoulder dystocia, were considered to have had complications at labour or delivery, or else none.
Covariates
The baseline covariates of interest included maternal level of education (none, primary, secondary, and tertiary or university), poverty status—whether the mother was below or above the poverty line, the cohort at enrolment into the project, gestational age at enrolment into the project (below or equals 12, 13–19, 20–26, and 27 and beyond), whether the mother had pregnancy complication at the past pregnancy or not, and the number of ANC visits from 1 to 5. These covariates were selected based on the conditional independence assumption—they are deemed to account for systematic differences between the exposed and unexposed groups, and to confound the exposure and outcome association. The covariates also preceded the outcomes of interest.
Statistical analysis
We summarised the categorical data using frequencies and percentages while numerical data were summarised using the mean with SD when normally distributed but the median and IQR when skewed. We tested differences in the proportions of categorical variables between the exposed and the unexposed groups using the χ2 test, and for normally distributed numerical data, the Student’s t-test was used. Probability values (p value) ≤5% were considered indicative of a statistical significance difference in covariate balance between the groups. To estimate the causal effects of the exposure (high-risk pregnancy) on the primary and secondary outcomes (risk for complication during pregnancy and labour or delivery), the double robust estimation (DRE) approach was used. DRE approach consists of both exposure and outcome regression models and offers the analyst two options instead of one to correctly estimate the causal effect of an exposure on an outcome.18 The model estimates are consistently correct provided one of the models is correctly specified but not necessarily both thus preventing model misspecification. The regression model was fitted using the exposure as a function of the baseline covariates and the outcome regression model was fitted using the outcomes (primary and secondary outcomes) as a function of the baseline covariates.19 Causal estimates were reported as the OR and 95% CI.
Sensitivity analysis and statistical power
To assess the robustness of the causal estimates, we performed a sensitivity analysis. Here, we compared estimates from the DRE approach to a non-causal estimate from a multivariable regression model. Furthermore, we estimated the statistical power of the study using data on the effect of exposure on complications during labour and delivery.
Patient and public involvement
Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Results
Characteristics of participants
Table 1 summarises the sociodemographic and obstetric characteristics of the participants. We studied 4419 women and 3271 (74.0%) had low-risk pregnancies at the first ANC. The age of the participants ranged from 15 to 49 years, with a mean of 25.6±6.27 years and the majority were aged 20–29 years (53.4%) and rural residents (87.4%). One thousand five hundred and twenty-three (40.7%) had ended at the secondary level of education while 3.247 (85.8%) were above the poverty line. Systematic differences between women with a low-risk and high-risk pregnancy at the first ANC were observed regarding residence, age, level of education, poverty line, cohort at enrolment, gestational age, number of ANC visits (all p<0.001) and complication at past pregnancy (p=0.001).
Table 1.
Characteristics of participants
| Variables | Level | Overall (n=4419) | Low (n=3271) | High (n=1148) | P value |
| Residence | Rural | 3860 (87.4) | 2774 (84.8) | 1086 (94.6) | <0.001 |
| Urban | 559 (12.6) | 497 (15.2) | 62 (5.4) | ||
| Age categories (years) | 15–19 | 876 (19.8) | 0 (0.0) | 876 (76.3) | <0.001 |
| 20–29 | 2358 (53.4) | 2230 (68.2) | 128 (11.1) | ||
| 30–39 | 1079 (24.4) | 958 (29.3) | 121 (10.5) | ||
| 40–49 | 106 (2.4) | 83 (2.5) | 23 (2.0) | ||
| Mean (SD) | 25.60 (6.27) | 27.3 (5.3) | 20.7 (6.2) | <0.001 | |
| Level of education | No school | 53 (1.4) | 34 (1.2) | 19 (2.0) | <0.001 |
| Primary | 1431 (38.3) | 987 (35.1) | 444 (47.6) | ||
| Secondary | 1523 (40.7) | 1117 (39.8) | 406 (43.6) | ||
| Tertiary/university | 734 (19.6) | 671 (23.9) | 63 (6.8) | ||
| Poverty status | Above poverty line | 3247 (85.8) | 2528 (88.9) | 719 (76.3) | <0.001 |
| Below poverty line | 539 (14.2) | 316 (11.1) | 223 (23.7) | ||
| Cohort | 1 | 395 (8.9) | 339 (10.4) | 56 (4.9) | <0.001 |
| 2 | 898 (20.3) | 726 (22.2) | 172 (15.0) | ||
| 3 | 1219 (27.6) | 953 (29.1) | 266 (23.2) | ||
| 4 | 1287 (29.1) | 963 (29.4) | 324 (28.2) | ||
| 5 | 542 (12.3) | 280 (8.6) | 262 (22.8) | ||
| 6 | 78 (1.8) | 10 (0.3) | 68 (5.9) | ||
| Gestational weeks at enrolment | Below or equal to 12 | 262 (5.9) | 218 (6.7) | 44 (3.8) | <0.001 |
| 13–19 | 896 (20.3) | 755 (23.1) | 141 (12.3) | ||
| 20–26 | 1657 (37.5) | 1377 (42.1) | 280 (24.4) | ||
| 27 and above | 1104 (25.0) | 589 (18.0) | 515 (44.9) | ||
| Not specified | 500 (11.3) | 332 (10.1) | 168 (14.6) | ||
| Number of antenatal care visits | 1 | 303 (6.9) | 61 (1.9) | 242 (21.1) | <0.001 |
| 2 | 576 (13.0) | 318 (9.7) | 258 (22.5) | ||
| 3 | 1520 (34.4) | 1145 (35.0) | 375 (32.7) | ||
| 4 | 1839 (41.6) | 1584 (48.4) | 255 (22.2) | ||
| 5 | 181 (4.1) | 163 (5.0) | 18 (1.6) | ||
| Complications in a past pregnancy | No | 4097 (92.7) | 3006 (91.9) | 1091 (95.0) | 0.001 |
| Yes | 322 (7.3) | 265 (8.1) | 57 (5.0) |
Complications during pregnancy and at labour or delivery
Overall (table 2), 1176 (26.6%) women had complications during pregnancy with the majority of the complications among those with high-risk than low-risk pregnancy at the first ANC visit (29.9% vs 25.5%, respectively, p=0.004). One thousand five hundred and sixty-two (35.3%) women had complications at labour or delivery, also with the majority of the complications among those with high-risk than low-risk pregnancies at the first ANC visit (42.5% vs 32.8%, respectively, p<0.001).
Table 2.
Magnitude of complications during pregnancy and at labour or delivery
| Variables | Level | Overall (n=4419) | Low (n=3271) | High (n=1148) | P value |
| Complications during pregnancy | No | 3243 (73.4) | 2438 (74.5) | 805 (70.1) | 0.004 |
| Yes | 1176 (26.6) | 833 (25.5) | 343 (29.9) | ||
| Complications at labour or delivery | No | 2857 (64.7) | 2197 (67.2) | 660 (57.5) | <0.001 |
| Yes | 1562 (35.3) | 1074 (32.8) | 488 (42.5) |
Effect of high-risk pregnancy on complications during pregnancy and at labour or delivery
Table 3 shows that high-risk pregnancy at the first ANC visit increased the occurrence of complications during pregnancy by 23% (OR, 1.23; 95% CI 1.04 to 1.46), and the occurrence of complication at labour or delivery increased by 24% (OR, 1.24; 95% CI 1.07 to 1.45). In sensitivity analysis using a non-causal multivariable regression model, the occurrence of complication during pregnancy increased by 22% (adjusted OR (aOR), 1.22; 95% CI 1.02 to 1.46) while that at labour or delivery increased by 20% (aOR, 1.20; 95% CI 1.03 to 1.41).
Table 3.
Effect of high-risk pregnancy on the risk for complications during pregnancy and labour or delivery
| Outcomes | Level | OR for double-robust estimation (95% CI) | Adjusted OR for multivariable analysis (95% CI) |
| Had complications during pregnancy | No | 1 | 1 |
| Yes | 1.23* (1.04 to 1.46) | 1.22* (1.02 to 1.46) | |
| Had complications at labour or delivery | No | 1 | 1 |
| Yes | 1.24** (1.07 to 1.45) | 1.20* (1.03 to 1.41) |
Exponentiated coefficients; 95% CIs in parentheses: *p<0.05, **p<0.01, ***p<0.001.
Sensitivity analysis and statistical power findings
The multivariable regression analysis findings are comparable to that of the DRE approach, with the occurrence of complications during pregnancy and labour or delivery remaining significantly increased, suggesting the causal estimates are robust. Regarding statistical power, our data show that of 1074 (32.8%) women with low-risk pregnancies at the first ANC visit had complications at labour or delivery compared with 488 (42.5%) with high-risk pregnancies (table 1). Based on these data and assuming complications would be higher in the high-risk pregnancy group compared with the low-risk pregnancy group by 5% (37.8%), our study would have an 85.6% statistical power at a 5% significance level, which is adequate in detecting a true difference in the population.
Discussion
We found high-risk pregnancy at the first ANC visit increases the occurrence of complications during pregnancy and labour or delivery among women in Kenya. Our results are consistent with previous studies conducted in similar settings, including a prospective cohort study in low-income and middle-income countries, which found that high-risk pregnancy is associated with an increased risk for maternal mortality secondary to maternal complications, as well as a fourfold risk for severe maternal morbidity during childbirth.1 13 14 There are several possible explanations for the relationship between high-risk pregnancy and subsequent complications and we attempt to mention a few of them. A high-risk pregnancy might have persisted throughout the pregnancy journey, leading to complications during labour and delivery.20–22 One reason for the possible persistence of the complication might be inadequate management of the complication. Furthermore, perhaps women who are high risk might have lack access to or usage of ANC services, which can lead to inadequate management of potential complications during pregnancy, labour or delivery.20 21 It is important to identify high-risk pregnancies early, during the first ANC visit, to provide appropriate obstetric and intrapartum monitoring and care to ensure maternal and neonatal survival. However, a standard schedule may need to be re-evaluated, with more flexible, tailored monitoring based on a woman’s individual risk profile rather than a one-size-fits-all approach. This is also supported by other studies that have found that pregnancy adverse outcomes are strongly influenced by either non-pathological or pathological pre-pregnancy risk factors at the first antenatal visit and that identification of high-risk pregnancies during the antenatal period can reduce adverse perinatal outcomes.23 Our findings have important implications for identifying and managing high-risk pregnancies during ANC in Kenya and similar settings.
Certain factors could be used by ANC staff to screen for and triage high-risk women who require additional monitoring and care.24 These include pre-existing conditions like diabetes, hypertension, HIV and anaemia; being overweight/obese or underweight; advanced maternal age over 35 years; teenage pregnancy under 20 years; having multiple fetuses; and previous caesarean delivery.25 26 Women with one or more of these risk factors could be flagged early during the first ANC visit for closer follow-up and management throughout pregnancy to prevent complications, and to ensure favourable maternal and neonatal health outcomes. One potential intervention would be to provide targeted ANC, including the management of underlying health conditions and the identification of warning signs of complications. Additionally, efforts to improve access to healthcare and promote the usage of ANC services might equally prove effective in reducing the risk of complications among high-risk pregnant women. Overall, these findings highlight the need for early identification and management of high-risk pregnancies to improve maternal and neonatal health outcomes. Health professionals and policymakers should prioritise efforts to identify and support women with high-risk pregnancies to reduce the risk of complications and improve maternal and neonatal health outcomes in Kenya.
Study strengths and limitations
Our study has strengths and limitations. First, the study provides important evidence on the causal relationship between pregnancy risk at the first ANC visits and the subsequent occurrence of complications during pregnancy and labour or delivery. The sample size was large, with adequate statistical power to detect a small effect size in the population. The analytical approach was rigorous and robust, guarded against model misspecification. The use of observational or real-world data provides strong external validity, suggesting the findings might be generalisable to similar settings and populations. Limitations include the lack of data to examine the causal effects of high-risk pregnancy on postpartum complication risk and the lack of qualitative data to contextualise the findings. Additionally, there are several unmeasured confounders such as antiretroviral therapy (ART) and viral load suppression status for those on ART since secondary data initially collected for programme monitoring and evaluation were analysed. We implore future research should fill these gaps including the investigation of factors contributing to high-risk pregnancies and the most effective interventions for their prevention. Despite the stated limitations, our study is the first to evaluate the causal effect of high-risk pregnancy on complication risk during pregnancy and labour or delivery in Kenya. Evidence will inform future studies.
Conclusions and recommendations
Women with a high-risk pregnancy at the first ANC visit have an increased occurrence of complications during pregnancy and at labour or delivery when compared with those with a low-risk pregnancy. There is a need to identify all women with a high-risk pregnancy for close obstetric and intrapartum monitoring and care to ensure their survival and that of the newborns.
Supplementary Material
Acknowledgments
We express our gratitude to the Children Investment Fund Foundation (CIFF) and their team members, namely Kerri Wazny, Kelvin Musau and Mihretab Salasibew for their invaluable contributions and support during the project implementation. We thank PharmAccess Foundation International and its team members particularly Emma Waiyaiya, Julie Fleischer, Leon Stijvers and Nicole Spieker for their support and collaboration in providing the datasets. Furthermore, we are deeply thankful to the Center for Effective Global Action (CEGA) at the University of California Berkeley, under the auspices of the East Africa Social Science Translation (EASST) fellowship programme.
Footnotes
Contributors: MB as lead author and guarantor was responsible for the overall content, conceptualisation, data acquisition, analysis, interpretation, writing the original draft, review and editing. JI was responsible for conceptualisation, data acquisition, analysis, interpretation, writing the original draft, review and editing. DTK was responsible for conceptualisation, supervision, writing critical reviews and editing. HOO was responsible for data acquisition for the study, constant coordination, writing critical reviews and editing.
Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests: None declared.
Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review: Not commissioned; externally peer reviewed.
Data availability statement
Data may be obtained from a third party and are not publicly available.
Ethics statements
Patient consent for publication
Not applicable.
Ethics approval
This study received ethical reviews and approvals from the African Population and Health Research Center (APHRC) Internal Ethics Committee (reference number DOR/2020/046) and subsequently the African Medical Research Foundation Ethics and Scientific Research Committee (AMREF-ESRC), reference number AMREF ESRC (ref # P911-2020). Both ethics committees granted a waiver of informed consent since the evaluation analysed existing medical records without interaction with the participants. In addition, although the participants gave consent for their data to be used for programme improvement, a waiver of additional consent was obtained for this secondary analysis. The data-sharing agreements was signed between our research centre and the mobile health wallet programme implementers. All data were de-identified to preserve the anonymity of the participants.
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Data may be obtained from a third party and are not publicly available.