Initial Contraceptive Choices of Women Enrolled in a Cluster-Randomized Trial in Southwest Trifinio, Guatemala.

INTRODUCTION: The aim of this analysis is to present initial contraceptive choices of women offered postpartum contraception in rural Guatemala. METHODS: We trained community nurses participating in the delivery of a home-based antepartum and postpartum care program in rural Guatemala in contraceptive implant placement and had them offer condoms, pills, an injection, or an implant at women's home-based 40-day postpartum visit in intervention clusters of a non-blinded, cluster-randomized trial. Women who had already started postpartum contraception or were over the age of 35 were excluded from participation. The primary outcome of the trial was contraceptive use at 3 months postpartum, so this initial analysis describes immediate preferences in the population. RESULTS: Of 208 women enrolled in the study, 108 were in intervention clusters and 100 lived in control clusters. In the intervention group, 32 women declined contraception, 36 women received the injectable, 30 women had an implant placed, 5 women started pills, 2 women chose condoms, and data on 3 women were missing. In the control clusters, 43 women were planning on the injectable, 11 planned on the implant, 10 did not want to start a method, 5 planned on sterilization, 2 aimed for natural family planning, 2 wanted a copper IUD, 1 woman wanted condoms, 18 did not know, and data on 8 women were missing. DISCUSSION: The contraceptive implant, which was not previously available in this community, had high uptake at 27.8% in the intervention group. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04005391; Retrospectively Registered 7/2/2019, https://clinicaltrials.gov/ct2/show/NCT04005391 Protocol: https://doi.org/10.1186/s13063-019-3735-3.

Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.

DESIGN: This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3 months post-enrollment. METHODS: In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and randomized to receive the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit. All participants receive comprehensive contraceptive counseling beginning at the first antenatal visit, so control clusters received this as part of routine care; this education preceded the study intervention. RESULTS: Once the 12 communities were combined into 8 clusters by expected birth volume and nurse team, which we expected to translate to eventual postpartum visits, the allocation sequence was generated in SAS. Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. We used descriptive statistics to produce counts and percentages of characteristics of the study population overall and by intervention arm followed by univariate modeling using a mixed effects regression adjusted for cluster. Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001. Women in control clusters overwhelmingly opted for the injectable contraceptive (94.6%) while women in intervention clusters chose both the injection (61.5%) and the implant (33.7%), p < 0.001. Implant use by 3 months, the primary outcome of the study, was significantly higher in the intervention arm (25.9%) compared to the control arm (3.6%), p < 0.001, RR 1.3 CI [1.2, 1.4]. CONCLUSION: Our study was designed to respond to previously identified barriers to contraceptive uptake, and it was successful. Not only did it increase overall use of contraception by 3 months, but it shifted that contraceptive use away from short-acting methods in favor of longer-acting methods, with high continuation and satisfaction rates and no adverse outcomes reported. TRIAL REGISTRATION: clinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.

Trends in the Mode of Delivery of Pregnant Women in Rural Guatemala from a Quality Improvement Database.

Purpose To evaluate trends and factors associated with mode of delivery in the rural Southwest Trifinio region of Guatemala. Description We conducted a retrospective analysis of self-reported antepartum factors and postpartum outcomes recorded in a quality improvement database among 430 women enrolled in a home-based maternal healthcare program between June 1, 2015 and August 1, 2017. Assessment Over the study period, the rates of cesarean delivery (CD) increased (from 30 to 45%) and rates of vaginal delivery (VD) decreased (70-55%) while facility-based delivery attendance remained stable around 70%. Younger age (23.5 years for VD vs. 21.6 years for CD, p < 0.001), nulliparity (25.1% for VD vs. 45.0% for CD, p < 0.001), prolonged/obstructed labor (2.4% for VD vs. 55.6% for CD, p < 0.001), and fetal malpresentation (0% for VD vs. 16.3% CD, p < 0.001) significantly influenced mode of delivery in univariate analysis. The leading indications for CD were labor dysfunction (47.5%), malpresentation (14.5%), and prior cesarean delivery (19.8%). The CD rate among the subpopulation of term, nulliparous women with singleton pregnancies in vertex presentation also increased from 20% of all CD in 2015, to 38% in 2017. Conclusion Among low-income women from rural Guatemala, the CD rate has increased above the World Health Organization (WHO) recommendations in a period of 3 years. Additional research on the factors affecting this trend are essential to guide interventions that might improve the appropriateness of CD, and to determine if reducing or stabilizing rates is necessary.

Delivery of home-based post-partum contraception in rural Guatemalan women: feasibility, recruitment and retention in a cluster-randomized trial.

BACKGROUND: Few cluster-randomized trials have been performed in rural Guatemala. Our objective was to describe the feasibility, recruitment and retention in our cluster-randomized trial. METHODS: In our cluster-randomized trial, a range of contraceptives were brought to mothers' homes in rural Guatemala. RESULTS: Of 173 women approached, 33 were excluded. Of the 140 eligible women, 127 (91%) consented to participate. Of the 87 women who should have been assessed for the primary outcome, three were lost to follow-up, which represents a retention rate of 97%. CONCLUSIONS: Nurses who are both clinical providers and study staff can feasibly conduct research, which leads to high enrollment and retention rates.

Prevalence and Predictors of Low Birth Weight in a Rural Guatemalan Community.

BACKGROUND: The intention of our study was to establish the prevalence of low birth weight (LBW) as well as risk factors for LBW in infants born to a convenience sample of women enrolled in a home visitation maternal care program associated with the Center for Human Development in Southwest Trifinio, Guatemala. METHODS: This is an observational study analyzing self-reported data from a quality improvement database. We recorded the distribution of birthweights of infants born to women enrolled in Madres Sanas that delivered between October 2018 and December 2019. We grouped women by LBW (<2500g ) and adequate birthweight (≥2500g) infants, and performed bivariate comparisons using sociodemographic, obstetric, and intrapartum data. Using the independent variables shown to have an association with LBW, we then performed a multivariable analysis. RESULTS: There were 226 births among our program participants, 218 with recorded birthweights. The median birthweight was 3175g; 13.8% were LBW (<2500g), higher than Guatemala's average of 10.9%. Through our bivariate analysis, we determined women with LBW infants were younger, with a median age of 20.8 (IQR [17.8-23.7]) compared to a median age of 23.2 (IQR [19.8-27.3]) among women with infants ≥2500g (P=0.03). Women with LBW infants were also more likely to have fewer than 4 prenatal visits (33.3% vs 19.3%, P=0.04). CONCLUSION: Two significant findings emerged from our analysis: LBW infants were more commonly born to women who were younger in age and who had received fewer than 4 prenatal visits. These findings are consistent with existing literature on LBW in Latin America. Our study helps to strengthen the data around these associations and gives credence to programming and policy efforts in Latin America that support adequate prenatal care for all and youth education about reproductive health and contraceptive access.

Challenges and lessons learned from the rapid operationalization of a prospective cohort to study the natural history and neurodevelopmental outcomes of postnatal Zika virus infection among infants and children in rural Guatemala.

During the course of the 2015-2017 outbreak of Zika virus (ZIKV) in the Americas, the emerging virus was recognized as a congenital infection that could damage the developing brain. As the Latin American ZIKV outbreak advanced, the scientific and public health community questioned if this newly recognized neurotropic flavivirus could affect the developing brain of infants and young children infected after birth. We report here the study design, methods and the challenges and lessons learned from the rapid operationalization of a prospective natural history cohort study aimed at evaluating the potential neurological and neurodevelopmental effects of postnatal ZIKV infection in infants and young children, which had become epidemic in Central America. This study enrolled a cohort of 500 mothers and their infants, along with nearly 400 children 1.5-3.5 years of age who were born during the initial phase of the ZIKV epidemic in a rural area of Guatemala. Our solutions and lessons learned while tackling real-life challenges may serve as a guide to other researchers carrying out studies of emerging infectious diseases of public health priority in resource-constrained settings.

Delivery of home-based postpartum contraception in Southwest Trifinio, Guatemala: Reach, adoption, and implementation in a cluster-randomized trial.

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. STUDY DESIGN: 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. 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.

Twelve-Month outcomes of a Cluster-Randomized Trial of Home-Based Postpartum Contraceptive Delivery in Southwest Trifinio, Guatemala.

DESIGN: We executed a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with three and 12-month contraceptive utilization, satisfaction, and pregnancy rates. METHODS: Eight clusters were randomized to receive either the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit in addition to routine care, or routine care alone, which included comprehensive contraceptive counseling throughout antepartum care. RESULTS: 208 women were enrolled in the study, 108 in the intervention clusters and 100 in control clusters. 94 (87.0%) women in the intervention group and 91 (91%) of women in control clusters were evaluated 12 months post-enrollment. Likelihood of using contraception at that time was borderline increased in intervention clusters (RR 1.1 [1.0,1.3], p = 0.05) with an increased likelihood of long-acting contraceptive use (the implant; RR 1.6 [1.3,1.9], p < 0.001). Pregnancy rates were also borderline reduced in the intervention clusters (RR 1.0 [1.0,1.1], p = 0.07). There was no difference in satisfaction of women with contraceptive use between arms with about 95% of women very satisfied or a little satisfied in each arm. Continuation rates at twelve months of contraceptives in the intervention group were 0.0% for condom users, 80.0% for contraceptive pill users, 57% for injectable users, and 83% for implant users. Most women who discontinued their initial method chose a more long-term or permanent method. There was a trend toward a significant association with reduced short interval pregnancy. CONCLUSION: Our study had a borderline increase in overall use of contraception by 12 months, did have an increased likelihood of long-acting contraceptive use of the implant by 12 months, and resulted in a trend toward reduced short interval pregnancy in the intervention clusters as compared to control clusters.

Characteristics Associated with Choosing Long-Acting Reversible Contraception in Rural Guatemala: A Secondary Analysis of a Cluster-Randomized Trial.

DESIGN: We conducted a secondary analysis of a cluster-randomized trial to observe characteristics associated with women who chose to use long-acting reversible contraceptives (LARC) compared to those who chose a short-acting method 12 months after enrollment. METHODS: The trial studied four control and four intervention clusters where the intervention clusters were offered contraception at their 40-day routine postpartum visit; control clusters received standard care, which included comprehensive postpartum contraceptive counseling. Women were followed through twelve months postpartum. RESULTS: The study enrolled 208 women; 94 (87.0%) were in the intervention group and 91 (91.0%) were in the control group. At twelve months, with 130 (70.3%) women using contraception at that time. 94 women (50.8%) were using a short acting method compared to 33 (17.9%) who chose a long-acting method, irrespective of cluster. In mixed effect regression modeling adjusted for cluster, characteristics associated with a reduced likelihood of choosing long-acting contraception in multivariate modeling included age (aRR 0.98 [0.96,0.99], p = 0.008) and any education (compared to no education; aRR 0.76 [0.60,0.95], p = 0.02). Women who were sexually active by their enrollment visit (40 days postpartum) were 30% more likely to opt for a long-acting method (aRR 1.30 [1.03,1.63], p = 0.03). CONCLUSION: Older and more educated women were less likely to be using LARC a year after enrollment, while women with a history of early postpartum sexual activity were more likely to choose LARC.

Use of Postpartum Birth Control in Rural Women in Southwest Guatemala: Analysis of a Quality-Improvement Database.

OBJECTIVE: Our objective was to observe the prevalence of postpartum contraceptive use in a population of rural women in Southwest Guatemala by type, and to determine characteristics associated with long-acting reversible contraceptive (LARC) use and sterilization. METHODS: We conducted a secondary analysis of prospectively collected quality improvement data from a cohort of postpartum women. We compared women intending to use or already using contraception to those not intending to utilize a method; bivariate comparisons were used to determine if there were differences in characteristics between these groups. If differences occurred (p < 0.2), those covariates were included in multivariable regression analyses to determine characteristics associated with use, and then specifically with LARC use and sterilization. RESULTS: In a cohort of 424 women who were surveyed between 2015-2017, the average age was 23 years old, and the prevalence of use or plan to use postpartum contraception was 87.5%. Women with a parity of 2 - 3 were 10% more likely to use any form of postpartum birth control (RR 1.1, CI [1.01, 1.2]) compared to primiparous women. Women who were married were also more likely to use a postpartum method (RR > 10, CI [>10,>10]). The prevalence of LARC use was low (4.0%), and women were more likely to choose this method if they were employed (RR 3.5 CI [1.1, 11.3]).Regarding sterilization, women with a parity of greater than one compared to primiparous women had an increased likelihood of sterilization (RR 3.6 CI [2.5,4.9]); each year a woman aged was associated with a 10% increased likelihood of postpartum sterilization (RR 1.1 CI [1.01,1.08]). Women were also more likely to choose sterilization if delivered by a skilled birth attendant (RR 1.8 CI [1.1,2.9]) or by cesarean birth (RR 2.1 CI [1.4,3.1]). CONCLUSION: In this cohort, married women of higher parity were more likely to use postpartum contraception, with employed women more likely to use a LARC method. Older women of higher parity who were delivered by a skilled attendant by cesarean birth were the most likely to pursue sterilization.

Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol.

BACKGROUND: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. METHODS: This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. DISCUSSION: A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town which is about an hour away by vehicular travel. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within 3 months of childbirth. The potential implications of this study include that nurses may be able to be trained to safely provide contraceptives, including placing implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04005391. Retrospectively registered on 1 July 2019.

Responding to the Zika Epidemic: Preparation of a Neurodevelopmental Testing Protocol to Evaluate Young Children in Rural Guatemala.

The ongoing Zika virus (ZIKV) epidemic in Latin America presented a unique opportunity to develop a neurodevelopmental assessment protocol for children in a lower middle-income country. Although studies of neurodevelopment in young children have taken place in many diverse global settings, we are not aware of any study that has provided a high level of detail about how a measure was selected and then specifically translated and adapted in a low-resource setting. Here, we describe considerations in measurement selection and then the process of translation and adaptation to assess neurodevelopmental outcomes of infants and young children with postnatal exposure to ZIKV in rural Guatemala. We provide a framework to other research teams seeking to develop similar assessment models across the globe.

Telehealth to Expand Community Health Nurse Education in Rural Guatemala: A Pilot Feasibility and Acceptability Evaluation.

Telehealth education has the potential to serve as an important, low-cost method of expanding healthcare worker education and support, especially in rural settings of low- and middle-income countries. We describe an innovative educational strategy to strengthen a long-term health professional capacity building partnership between Guatemalan and US-based partners. In this pilot evaluation, community health nurses in rural Guatemala received customized, interactive education via telehealth from faculty at the supporting US-based institution. Program evaluation of this 10 lecture series demonstrated high levels of satisfaction among learners and instructors as well as knowledge gain by learners. An average of 5.5 learners and 2 instructors attended the 10 lectures and completed surveys using a Likert scale to rate statements regarding lecture content, technology, and personal connection. Positive statements about lecture content and the applicability to daily work had 98% or greater agreement as did statements regarding ease of technology and convenience. The learners agreed with feeling connected to the instructors 100% of the time, while instructors had 86.4% agreement with connection related statements. Instructors, joining at their respective work locations, rated convenience statements at 100% agreement. This evaluation also demonstrated effectiveness with an average 10.7% increase in pre- to posttest knowledge scores by learners. As the global health community considers efficiency in time, money, and our environment, telehealth education is a critical method to consider and develop for health worker education. Our pilot program evaluation shows that telehealth may be an effective method of delivering education to frontline health workers in rural Guatemala. While larger studies are needed to quantify the duration and benefits of specific knowledge gains and to perform a cost-effectiveness analysis of the program, our initial pilot results are encouraging and show that a telehealth program between a US-based university and a rural community health program in a low- and middle-income country is both feasible and acceptable.