Abstract
Objective:
The objective of this analysis was to present our secondary outcomes (reach, adoption, implementation, maintenance domains) of a prospective trial to test the efficacy of a home-based intervention to increase postpartum contraceptive uptake.
Methods:
We executed a cluster-randomized trial to determine if provision of contraception in the home setting increased uptake of postpartum methods. We collected secondary outcomes on how our implementation strategies of revising professional roles and changing service sites performed in terms of the number of people our study enrolled of all women eligible (reach), how it was accepted by the providers (adoption), what methods were used to conduct the study (implementation), and preliminary results on whether or not the intervention will be continued (maintenance). We conducted a survey and focus group discussion to assess adoption and implementation among intervention nurse staff, and a survey in a convenience sample of patients in the intervention arm to assess acceptability.
Results:
Our primary outcome of effectiveness has been published; implant uptake was 25% in the intervention cohort compared to 3% in the control clusters. Our reach was 89%, as 208 of the 234 eligible women consented to participate. Among a convenience sample of N = 25 patients completing a survey on the intervention 12 months after enrollment, ≥ 68% (n = 17 of 25) felt the intervention was acceptable. From the nursing perspective (N = 7), only a minority of nurses felt the intervention was complicated (n = 1, 17%), and (n= 7, 100%) reported the intervention was acceptable.
Conclusions:
Our intervention achieved good reach (89% of the eligible population) and was acceptable to the majority of patients and providers. Practitioners interested in achieving greater reach of contraceptive interventions in their communities may consider changing service sites to convenience their clients, as our results suggest this approach was acceptable.
Keywords: community-based programming, contraceptive implant, Guatemala, long-acting reversible contraception, postpartum contraception
1. Introduction
Postpartum contraception is essential to preventing closely-spaced, undesired, and unintended pregnancies [1]. Sixty-six percent of reproductive age women in Latin America reportedly do not desire to be pregnant, but over 20% of women are not using modern contraception, and they account for 75% of unintended pregnancies [2]. In Guatemala, there is reportedly a 67.6% unmet need for contraception in the postpartum period with only a quarter of the population utilizing effective contraceptives [3].
In a rural area of Guatemala called the Southwest Trifinio region, the contraceptive implant is not readily available [4]. Women historically had to travel one hour by car to the closest town to seek the implant, if that was of interest to them. Otherwise, they obtained external (male) condoms (about USD15/144 condoms), oral contraceptive pills (about USD2/month supply), or the injection (about USD3/injection) at local health posts or pharmacies. About 30% of women in the Southwest Trifinio region deliver at home, so presenting to the health post postpartum is the only means of obtaining contraception [5]. For those who deliver at the referral hospital, all contraceptive options are available and delivered by a family planning specialized physician. Most women, however, do not start contraception until 40 days postpartum and therefore also rely on the health posts [4].
The Southwest Trifinio is supported by an existing community-based nursing program called Madres Sanas, which is affiliated with the Center for Human Development, a clinic associated with the University of Colorado in the United States [6]. The program provides pregnant women with antepartum and postpartum care in the home setting; nurses travel to patients’ homes from the Center for Human Development in teams of two by way of motorized rickshaws on a daily basis to provide care. Contraceptive counseling and education on proper pregnancy spacing is an integral component of the prenatal care provided and predated our study.
Because of the gap in care around availability of the contraceptive implant in the Southwest Trifinio, we conducted a cluster-randomized, pragmatic, parallel arm trial whereby postpartum women in communities served by the Madres Sanas program were randomized into intervention and control clusters [7]. Women in the intervention clusters, if they met inclusion criteria, were offered contraceptives (external condoms, oral contraceptive pills, injection, implant) free of cost in their homes at their 40-day postpartum visit by the Madres Sanas nurses. Women in control clusters received routine care (that includes prenatal contraceptive counseling and education) but were not offered contraceptives in the home (though it remained available in the community) [7]. The main objective of the original study was to observe if the reduced access barrier of providing contraceptives at the home-based postpartum visit was associated with an increase in implant uptake by three months post-enrollment [7]. Our primary outcome of effectiveness has been published; implant uptake was 25% in the intervention cohort compared to 3% in the control clusters [8].
This analysis serves to present our secondary outcomes related to the domains of reach, adoption, implementation, and maintenance of our intervention (delivery of postpartum contraceptives) as a whole, not just the delivery of implants, using a mixed methods study design. As part of implementation, we focused on the acceptability, appropriateness, and feasibility of the intervention from both the patient and provider perspectives.
2. Materials and methods
2.1. Design:
Figure 1 illustrates the design of our original cluster-randomized trial. Twelve communities were combined into 8 clusters and then randomized into 4 intervention (left side of diagram) and 4 control clusters (right side). Women were excluded from enrollment in the original trial if they were older than age 35 (the community advisory board requested a focus on younger women), if they had already initiated a postpartum contraceptive method, and if they were unwilling or unable to provide informed consent. To be included women had to be postpartum and available and able to consent at their 40-day postpartum visit. Women involved in this analysis were only from the intervention clusters as our questions centered specifically on their experience of the intervention.
Figure 1.
Randomized controlled trial CONSORT diagram with details on nurse (N = 7) and women (N = 25) participants who reported on secondary outcomes for this analysis, Southwest Trifinio, Guatemala, October 2018 – February 2020
The design of our data collection on implementation outcomes was a convergent mixed method study design guided by the RE-AIM framework involving a nurse survey and focus group discussion, and a patient survey [7] [9]. At the time of the mixed method data collection with the nurse sample, the study was fully enrolled and had just completed the three-month primary outcome timepoint but had not finished collecting 12-month outcomes. Implementation outcomes were added on after the start of the trial, and as such, were not described in the original protocol. Six nurses executed the study under the guidance of one nurse supervisor who functioned as the study coordinator; for the purposes of assessing these secondary outcomes, we surveyed the nurses and then discussed the results in a focus group discussion setting.
A convenience sample of 25 women from the intervention clusters participated in a patient survey conducted 12-months after enrollment. However, as the implementation outcomes were added on to the protocol, only 25 women had their 12-month survey outstanding at the time of the roll-out of the patient survey. Therefore, the women were not sampled according to an a priori strategy and were simply the remaining convenience sample of women who had not yet reached the 12-month study time point. The data collection with study nurses/staff occurred in February 2020, and the survey with patients occurred at their timed 12-month follow-up, which concluded in November 2020. We registered the original trial at clinicaltrials.gov (NCT04005391).
2.2. Outcomes:
RE-AIM domains include reach, effectiveness, adoption, implementation, and maintenance [9]. We specifically focused in this study on reach, adoption, implementation, and maintenance as well as additional key constructs related to these domains: acceptability, appropriateness, feasibility, and cost [9]. Reach is defined as the proportion of the target population that participated in the intervention of all eligible women. All women involved in the Madres Sanas program living in the study clusters were approached and screened for inclusion in the study; therefore, we calculated reach as the number of those women who enrolled over the denominator of all women who were eligible to participate [9]. Adoption refers to the proportion of providers that adopt the intervention [9]. We measured implementation as the extent to which the intervention was implemented as intended, according to the nurses themselves, also asking about cost of the contraceptives as part of this domain [9]. Maintenance is defined as the degree to which the program is able to be sustained after the research study period is over.
2.3. Survey design:
The nurse survey we designed was comprised of 18, four-point Likert scale questions that we translated from Weiner and colleagues’ quantitative tool to assess acceptability, appropriateness, and feasibility of the intervention [10]. We piloted the wording of the questions with native Spanish speakers and with the study coordinator to ensure comprehension. After the administration of the nurse survey, we conducted a focus group discussion to delve deeper into how and why the respondents determined the intervention was or was not acceptable, appropriate, and/or feasible [11]. We designed the patient questionnaire to include nine, four-point Likert scale questions that we also modeled after Weiner and colleagues’ quantitative tool to assess acceptability, appropriateness, and feasibility of the intervention, as when programs are highly acceptable, appropriate and feasible to patients, this is related to future successful program reach [10].
2.4. Sampling approach:
After completing the survey assessing implementation outcomes, in a focus group discussion setting, the nurses/nursing supervisor (N = 7) were asked to share their responses to the survey and to discuss additional prompts. To limit response bias, the principal investigator (PI) was not present in the room during the focus group discussion, and the respondents knew their responses would be recorded in a de-identified manner. Regarding the patient cohort, a subset of intervention patients (N = 25) completed the implementation survey as they concurrently completed a survey on 12-month effectiveness outcomes. Per above, this was a convenience sample of women from intervention clusters; they were the remainder of women who had not yet completed their 12-month study timepoint when we added these secondary outcomes to the trial.
2.5. Intervention & implementation strategies:
To interpret better our implementation outcome data, it is important to describe what and how the intervention was delivered. In implementation science terms, “what” the intervention is may be conceptualized as its core components or core functions, and “how” it was delivered may be considered as the implementation strategies [12]. In terms of “what” the intervention was, its core component was to offer postpartum women modern contraceptive methods at their 40-day postpartum visit in their home as part of their routine visit. Further detail on the intervention can be found in our study protocol and primary outcome paper [7, 8, 12].
Regarding the “how” of intervention execution, we used the Expert Recommendations for Implementing Change (ERIC) compilation of 73 different types of strategies to specify our implementation strategies [12]. Our first implementation strategy was to train the community nurses in implant placement (ERIC strategy: “revise professional roles”) so they could administer the contraceptives. The nurses were trained by the PI in implant placement and were required to have ten implant placements observed before they were approved to place implants as part of the trial. For nurses who did not achieve their ten placements during the site initiation visit, a local family planning organization (PASMO) oversaw the additional placements. The nurses were also given educational lectures and laminated copies of the World Health Organization eligibility criteria for ease of reference during the study. Because the nurses had already been providing contraceptive counseling through the program prior to the onset of the trial, this aspect of the study was not scripted.
Our second strategy was the ERIC method of “changing service sites”. In the case of our study, changing service sites refers to contraceptive delivery in the home setting as opposed to the health posts, which we hypothesized would reduce an access barrier to postpartum contraceptive uptake [4].
2.6. Analysis:
We report descriptive statistics of the quantitative implementation outcomes of reach, adoption, and implementation. For the focus group discussion with nursing staff, we used a content analysis approach [13]. Two researchers independently coded the transcript. All codes were then mutually exclusively separated by the researchers into adoption and implementation codes; cost codes were included under implementation. The components were independently analyzed by the researchers before findings of the quantitative and qualitative components were merged. We performed data merging using “common thread analysis”, which focused on finding common themes in both datasets within the RE-AIM framework [14]. To assess fidelity, which falls under the RE-AIM dimension of implementation, we observed the timeline of implant uptake by nursing teams across the timeframe of the study to see if implant placement was consistent over time.
3. Results
Table 1 describes the nursing staff sample (N = 7), who completed both the survey and focus group discussion. The participants were all women, ranged in age from 21 – 30 years old (median 24 years and interquartile range (IQR) 22 – 25 years), and varied in training level from auxiliary (lowest level of training) to professional to licensed (highest level of training). Among the patient participants (N = 25), the median age was 22.5 years with an IQR of 17.6 to 26.1 years, 89% of the women had some level of primary education (compared to no formal education), 40% were primiparous with 60% having two or more children, and 95% of the women were not single.
Table 1.
Characteristics of the women (N = 25) and nurses (N = 7) who participated in the surveys and the nurse focus group discussion, Southwest Trifinio, Guatemala, October 2018 – February 2020
| Characteristics of nurse participants | |
|---|---|
| N, % | |
| Female sex | 7, 100% |
| Age (median, IQR) | 24 [22,25] |
| Training | |
| Auxiliary | 2, 28% |
| Professional | 4, 57% |
| Licensed | 1, 15% |
| Characteristics of patient participants | |
| N, % | |
| Age (median, IQR) | 22.5 [17.6,26.1] |
| Some education | 21, 84% |
| Missing | 1, 4% |
| Not single | 22, 88% |
| Missing | 1, 4% |
| Parity | |
| 1 | 10, 40% |
| 2+ | 15, 60% |
| Contraceptive choice | |
| No method | 6, 24% |
| Male external condoms | 0, 0% |
| Contraceptive pills | 2, 8% |
| Injection | 12, 48% |
| Implant | 3, 12% |
| Missing | 2, 8% |
Overall, our program had a reach of 89%, as 208 of the 234 eligible women consented to participate (N = 284 women approached for inclusion; 50 were not eligible to participate by the exclusion criteria of age or they were already using contraception). In terms of the representativeness of the study population, we compared those who consented to those who did not (data not shown) and found that women who were enrolled were more likely to have some education compared to none (88% vs 73%), p = 0.01. Enrolled women did not differ by marital status, number of prenatal visits, mode of birth, location of birth, birth attendant, infant birthweight, infant sex, sexual activity by the postpartum visit, or by when they wanted their next pregnancy, p > 0.05. These comparison data are collected routinely as part of our Madres Sanas program (COMIRB #15-0909). The excluded population was older and more parous as women older than 35 were excluded (due to a community preference for a focus on pregnancies among a younger population).
Table 2 describes the acceptability of our intervention from the patient perspective, which is related to reach. The majority of women agreed that the intervention was comfortable (72%), acceptable (72%), appealing (72%), and they liked the intervention (76%). They also agreed or strongly agreed that the intervention was compatible with their needs (76%), that they would be willing to pay some subsidization for the delivery of contraceptives to their home (84%), and that the implant is a good contraceptive method for some women (80%) and is easy to have placed in the home setting (68%; 3 of these 17 women did have the implant placed). Of note, among the 32% (n = 6 women) who thought the implant was not easily placeable in the home setting, none of them opted for the implant. Instead, they chose not to start a method (n = 2), 1 woman chose oral contraceptive pills, and 3 of the women chose the injectable contraceptive. A majority also reported being happy the nurses were trained in implant placement (68%).
Table 2.
Results of patient (N = 25) questionnaire, Southwest Trifinio, Guatemala, October 2018 – February 2020
| Questionnaire prompts (Likert scale)a | |
|---|---|
| Statement | Result (n, %) |
| I felt comfortable receiving the contraceptives in my home | |
| Disagree or strongly disagree | 6, 24% |
| Strongly agree or agree | 18, 72% |
| Missing | 1, 4% |
| Bringing contraceptives to my home at my postpartum visit was acceptable to me | |
| Disagree or strongly disagree | 7, 28% |
| Strongly agree or agree | 18, 72% |
| Missing | 0, 0% |
| Bringing contraceptives to my home at my postpartum visit was appealing to me | |
| Disagree or strongly disagree | 7, 28% |
| Strongly agree or agree | 18, 72% |
| Missing | 0, 0% |
| I liked the intervention of bringing contraceptives to me in my home | |
| Disagree or strongly disagree | 6, 24% |
| Strongly agree or agree | 19, 76% |
| Missing | 0, 0% |
| Bringing contraceptives to my home at my postpartum visit was compatible with my needs | |
| Disagree or strongly disagree | 6, 24% |
| Strongly agree or agree | 19, 76% |
| Missing | 0, 0% |
| If the intervention were not free and I would have to pay some or all of the contraceptive cost, I still think bringing contraceptives to women at their postpartum visit is worth continuing | |
| Disagree or strongly disagree | 4, 16% |
| Strongly agree or agree | 21, 84% |
| Missing | 0, 0% |
| I think the contraceptive implant is a good contraceptive method for some women | |
| Disagree or strongly disagree | 5, 20% |
| Strongly agree or agree | 20, 80% |
| Missing | 0, 0% |
| I think the contraceptive implant is easy to have placed in the home setting | |
| Disagree or strongly disagree | 8, 32% |
| Strongly agree or agree | 17, 68% |
| Missing | 0, 0% |
| I am happy the nurses were trained in contraceptive implant placement | |
| Disagree or strongly disagree | 7, 28% |
| Strongly agree or agree | 17, 68% |
| Missing | 1, 4% |
: Likert Scale: strongly disagree, disagree, agree, strongly agree
Note: reach denotes how representative the participant population was of the eligible population
We integrated our quantitative data and qualitative data analysis from the study nurses into a joint display (Table 3) with respect to the implementation domains of adoption and implementation. As shown, all the nurses (100%) agreed or strongly agreed that the intervention was acceptable and appealing to them, they liked it, that it was a good fit for everyday use, would be possible to continue, and that they wanted to continue to deliver contraceptives to women in the home setting. A majority of nurses (86%) agreed or strongly agreed that they were comfortable delivering the study intervention and that in retrospect, they were happy they had been trained in implant placement. In addition, only one of the 7 nurses (17%) agreed or strongly agreed that the intervention was complicated.
Table 3.
Quantitative and qualitative results of the nurse survey and focus group discussion (N = 7) Southwest Trifinio, Guatemala, February 2020
| Domain | Quantitative nurse survey questions | Survey result of agree or strongly agree | Qualitative nurse interview themes |
|---|---|---|---|
| Adoption | Nurses felt the intervention: | ||
| -Complicated | 1,17% (1 missing) | Counseling patients | |
| -Comfortable | 6, 86% | Education on medical eligibility | |
| -Acceptable | 7, 100% | ||
| -Appealing | 7, 100% | Equitable intervention | |
| -Liked It | 7, 100% | Builds trust | |
| -Want to continue | 7, 100% | Hard to find consent witness | |
| -Good fit for everyday use | 7, 100% | ||
| -Possible to continue | 7, 100% | Too long to consent | |
| -Happy trained in implant Placement | 6, 86% | ||
| -Continue with cost subsidization | 6, 86% | ||
| Implementation | Nurses felt the intervention: | ||
| -Delivered consistently | 7, 100% | Extended counseling | |
| -Easy to deliver | 6, 86% | Formal training on methods | |
| -Too much time to deliver | 3, 43% | ||
| -Implant easy to place in home setting | 6, 86% | Formal education on methods |
In the focus group discussion, the most prominent concern about continuing to deliver contraceptives in the home setting at the postpartum visit, which on the whole the nurses wanted to do, was related to the research consent process. The research consent process was separate from the informed consent for conducting an implant placement procedure. The nurses were happy they had had formal training in implant placement and other contraceptive methods, but they were interested in additional education on medical eligibility criteria for the various contraceptive methods. They reported, “Criteria, that’s the—if she can use it with respect to her illness. If she had high blood pressure, suffered from liver disease, issues like that.” The theme of accessibility for all women in the region also was noted, as during the study only certain communities were randomized to receive the intervention; the nurses suggested that delivery to everyone would build more trust between the nursing program and the communities.
The final issue that concerned the nurses was the cost of the contraceptives. Most of the nurses (86%) agreed or strongly agreed that the intervention should continue, or be maintained, in all communities, with cost subsidization. There was a long discussion about what would be the right cost to charge women, with the concern that in some communities there is no ability to pay despite a willingness to pay. In general, there was the feeling among the nurses that somewhere between 10 to 50 quetzals (about USD2 – 7 US) might be feasible for some women for the various methods, but with the disclaimer that, “when we ask, ‘Have there been times when your family has not eaten for the whole day?’ And many times, they have answered yes…if they don’t even have enough for food, much less will they have for the contraceptive…for them the most accessible would be ten (quetzals).” The nurses also came up with innovative concepts such a sliding pay scale and encouraging women to save up to pay for their contraceptive method throughout pregnancy, which could be included in the counseling provided at Madres Sanas antepartum visits.
Our results related to the implementation of our study (Table 3) suggest that most nurses (86%) agreed or strongly agreed that the intervention was easy to deliver and that the implant was easy to place in the home setting. Almost half (43%) agreed or strongly agreed that the intervention took too much time to deliver, with extended research consent counseling emerging as a theme related to time consumption. In terms of fidelity, 100% of nurses reported delivering the program consistently throughout the study, based on agreement with this survey item: “I delivered the intervention the same way throughout the study”. When asked about the concept of fidelity over time, one nurse explained that the content of the counseling did not change, just the quickness and confidence with which they delivered the counseling. They reported, “We had more word fluency, more confidence like you said. But the information was always the same, the information didn’t change, only the trust, both in ourselves as well as the ladies…when we offered them the study, it was more specific, then it was straight to the point.” As an objective measure of fidelity, we found comparable frequency of implant placement by the 3 nursing teams (9 – 11 implants per team over the study period; 11 by team 1, 9 by team 2, and 10 by team 3).
All REAIM domains are defined and summarized in Figure 2 with a summary of our findings also presented. Reach, effectiveness, adoption, and implementation have been explored, but it is important to highlight findings related to sustainability and maintenance. The nurses were interested in maintenance and requested to continue providing contraception as part of the Madres Sanas program outside the context of the study, which they have been doing since July 1, 2020. Contraceptives have continued to be provided free of cost during this time. When the data was last reviewed in January 2021, 99 women had been offered contraception, 51 opted for a method, and 16 women had an implant placed. These findings suggest that our intervention was indeed acceptable, appropriate, feasible, and mostly importantly, sustainable.
Figure 2.
Results of the RE-AIM implementation research framework, by domain, Southwest Trifinio, Guatemala, October 2018 – February 2020
4. Discussion
Overall, our home-based intervention that sought to increase access to contraception in a rural community of Guatemala had excellent reach, enrolling almost 90% of eligible participants, it was adopted by 100% of the community nurses, 100% of participating nurses wished to continue to offer contraceptive home visits in the future, and it had favorable measures of acceptability, appropriateness and feasibility among patients and nurses. One of the major issues with feasibility identified was the time required to conduct the study consent procedure (not the contraceptive consent), but this would not be necessary if the home contraceptive visits were adopted as a standard part of the nurses’ scope of work outside the context of a formal study. In terms of maintenance and sustainability, it should be noted that the nurses have taken initiative and have continued to provide contraception to all Madres Sanas participants outside the context of the study, beginning program sustainability of their own volition.
A key threat to sustainability from the nurse perspective was the need for cost subsidization of the contraceptives offered, which were paid for by the research study. In terms of the acceptability and feasibility of the intervention to patients, when they were asked, “if the intervention were not free and I would have to pay some or all of the contraceptive cost, I still think bringing contraceptives to women at their postpartum visit is worth continuing”, 84% of women agreed or strongly agreed with this statement. This is particularly intriguing given that the nursing staff had major concerns about whether the patients could afford even a small contraceptive co-payment of about USD2-7 US equivalent. Prior research has suggested that contraception is cost effective when considering unplanned births and resultant unsafe abortions and maternal deaths.[15] The savings are particularly notable in low- and middle-income country settings where population growth is rapid and modern contraception, with a focus on LARC, could have a major impact [16]. Research specific to Latin America and the Caribbean has found that reducing financial and nonfinancial barriers to family planning services is essential [17]. The nurses suggested a cost range of 10 – 50 quetzals depending on a sliding scale and the type of contraceptive offered. Our organization has received some previous contraceptive funding from private donor organizations, but it would be important to partner with the regional Ministry of Health or pursue additional donor funding and/or contraceptive donations to sustain our program without financially burdening women in the region.
Our implementation strategies to increase access to postpartum contraception by bringing modern methods (including the implant) to women’s homes were, from the nurse provider perspective, easily and consistently delivered. This supports prior research that has found non-physician, community-based distribution of contraception in Latin America is the “most acceptable and successful innovative approach to date” in the region [18]. During enrollment of our study we suspected that high enrollment and retention rates were the result of a relationship of significant trust established by the nurses in the existing Madres Sanas community nursing program with their patients, and we feel the baseline community trust contributed to our program’s high rates of reach, acceptability, appropriateness, and feasibility among patients [19]. Our implementation experience implies that community-based programming in low-resource areas of Guatemala may be an effective approach to increasing postpartum contraceptive distribution and initiation, and may be scalable to other areas of the country and region where similar infrastructure exists.
The lowest levels of agreement on our questionnaire were the questions that asked about implant placement in the home setting from the patient perspective. Only 68% of women felt implant placement in the home was easy and 68% found it acceptable to have nurses trained in implant placement. Given these results, which were generally lower than the agreement showed with other questions, it would be interesting to see how rates of implant uptake might vary or rates of support for the implant might change if our intervention supported transportation for placement in the local clinic instead of the home setting.
Our study is limited by the fact that our study was not designed with an implementation aim a priori, so we did not have opportunity to obtain qualitative feedback from patients [12]. However, it was easy to collect these secondary implementation outcomes from patients with minimal financial or time burden from the available patients, and we were able to obtain both qualitative and quantitative data from the nursing staff. We also feel we did not fully explore adoption with the nurses; they were enthusiastic about participating because they wanted to be trained in implant placement as part of the protocol. It was a missed opportunity to not ask them if they would have wanted to participate in testing the home-based intervention if they already had the capacity to place implants. Similarly, the lack of qualitative data from the patient perspective was limiting. For example, detail on why fewer women thought home provision of implants was easy would have been interesting. Additionally, our study is limited by the fact that we offered contraceptives free of charge as part of our intervention; we do not know how much this choice may have biased our sample. It is possible that we had a higher reach than would be otherwise achieved if the contraceptives were not fully subsidized. A strength of our study was the concurrent mixed methods approach, which offered the opportunity to collect data from multiple sources to enhance the richness of our findings.
In conclusion, this pragmatic cluster-randomized trial achieved exemplary reach, and was highly acceptable and feasible to deliver, due in no small part to the existing trust with the community nursing program in this area of rural Guatemala. This intervention is ready for study in alternative settings. An important next step would be to conduct a pragmatic trial of delivering home-based contraception in other communities with existing community nursing programs in place, and to work with stakeholders to determine how to address the key program sustainability threat identified: the need for cost subsidization of contraceptives.
Implications:
The unique contribution of this paper is in its success with training nurses to insert contraceptive implants during postpartum home visits, which resulted in increased uptake of the contraceptive implant where access to the device was previously limited. Given the trial’s successful feasibility and acceptability to both nurses and patients, perhaps this intervention has the potential to be adapted and scaled to other settings.
Acknowledgements:
We wish to acknowledge the Madres Sanas community nurses for the high-quality work they do in the Southwest Trifinio that significantly impacts the lives of the women and children they serve, and now, through the dissemination of research they have conducted, has the potential to impact women and children beyond the Southwest Trifinio community.
Funding:
Funding for this project comes from the Eunice Kennedy Shriver National Institutes of Child Health and Human Development Women’s Reproductive Health Research K12 award (5K12HD001271-18) and the Doris Duke Charitable Foundation.
Footnotes
Ethics: The study protocol, the data collection forms, and the consent form were approved by both the Colorado Multiple Institutional Review Board and their International Research Advisory Committee (COMIRB # 17 – 1314) in the United States of American as well as by the Instituto de Nurtición de Centro América y Panamá (INCAP) in Guatemala (CIE-REV 076/2018), and by the Community Advisory Board of the Madres Sanas program in the Southwest Trifinio. Both ethics review committees are providing ongoing review of the study as it is being conducted.
Informed Consent: All human participants gave written informed consent before the study began.
Conflicts of Interest: The authors have no relationships to disclose that may be deemed to influence the objectivity of this paper and its review. The authors report no commercial associations, either directly or through immediate family, in areas such as expert testimony, consulting, honoraria, stock holdings, equity interest, ownership, patent-licensing situations or employment that might pose a conflict of interest to this analysis. Additionally, the authors have no conflicts such as personal relationships or academic competition to disclose. The findings presented in this paper represent the views of the named authors only, and not the views of their institutions or organizations. A consent for publication section was not necessary. No individual-level data is presented in this manuscript, only de-identified aggregated data of women who consented to participate in the study and publication of the analysis.
Data Availability:
Data available on request due to privacy/ethical restrictions
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data available on request due to privacy/ethical restrictions