Study setting and design
We conducted our study in Bunyala, a rural sub-county in Busia, Western Province, from July 2012 to June 2014. We selected Bunyala for two primary reasons: (1) the MMR and NMR are much higher than national estimates, and (2) the MOH demonstrated strong interest and support of AMPATH’s programs and collaborations. Women and infants in Western Province suffer from the second highest maternal and neonatal mortality rates in Kenya.2,22,23 In Busia County, the most recent estimate for infant mortality rate (IMR) is exceedingly high at 125.9 per 1,000 live births.24 In Bunyala, MNCH activities, including antenatal and postpartum care led by the GOK and supported by AMPATH, exist across 16 community units and 8 MOH health facilities.
To evaluate the association of Chamas participation on uptake of positive MNCH behaviors, we employed a prospective, matched-cohort study design. We compared outcomes between a cohort of Chamas program participants, who we recruited during their first ANC visits at public health facilities in Bunyala, and non-participating controls matched for age, parity, and prenatal care location who we identified through health facility registers. We followed both cohorts prospectively for one year and recorded outcome data between 6-12 months postpartum for all participants.
Participant selection
We employed a facility-based recruitment strategy to enroll women to our intervention cohort. We invited all pregnant women attending their first ANC visit at an MOH-sponsored health facility in Bunyala between October-December 2012 to enroll in the Chamas program and to participate in this study (Figure 1). We did not exclude women based on any sociodemographic or reproductive health factors including age, education-level, employment-status, marital status, parity, or prior history of facility delivery.
To recruit our control cohort, we retrospectively identified pregnant women who attended the same health facilities for their first ANC visits in the three months preceding Chamas enrollment (July-September 2012) from clinic registers. We matched controls based on three criteria: age, parity, and prenatal care location (health facility). We tasked CHVs with approaching eligible women at their homes, if they provided an address; we then enrolled women who CHVs successfully located and agreed to participate (Figure 1). Women in both cohorts provided baseline sociodemographic and reproductive health data at the time of enrollment and consented to complete a follow-up survey at 6-12 months postpartum.
Community Health Volunteers in Kenya
The Chamas program leverages the important role of CHVs in the community to deliver health and microfinance education in a safe and familiar setting. As delineated by Kenya’s community health strategy, CHVs are members of the community, nominated from within, who are tasked with improving the community’s health and well-being as well as linking individuals to primary health care services.25 CHVs are considered part-time government volunteers and are supervised by Community Health Extension Workers (CHEWs) who are salaried frontline healthcare providers integrated within government health facilities.26 CHVs involved in this study across both intervention and control cohorts were connected to eight health facilities, specifically: five dispensaries, two health centers, and one sub-county level hospital.
Nationally, the Kenyan government delineates a CHV’s scope of work to include: monthly household visits within a defined catchment area of 20 households in rural areas and 100 households in urban areas.27 During routine visits, CHVs collect basic health information, identify health problems, and refer individuals needing additional services to health facilities. All CHVs are required to complete a 10-day, MOH-led basic training session prior to beginning work during which they are introduced to a broad array of health topics, including MNCH. With regard to MNCH, CHVs are provided with a handbook that covers basic information on caring for mothers during and after pregnancy, instructions on facilitating the creation of an individualized birth plan, and lists of specific health behaviors CHVs are encouraged to promote (i.e. attend ANC, deliver in health facilities, adopt family planning).27 CHVs are also expected to recognize danger signs during pregnancy as well as perform basic nutritional assessments, aid in growth monitoring, and recognize when infants require further evaluation for malnutrition. This basic training is often supplemented by specific technical training that align with local priorities; however, technical sessions are variable and implemented by local governments or non-governmental organizations.27
In September 2012, we selected 32 GOK sponsored CHVs to participate in an additional four-day technical training session on Chamas, sponsored by AMPATH and the Busia County MOH. During these sessions, we trained attendees on how to deliver our evidence-based health curriculum using an illustrated flipchart, facilitate participatory group discussions, and equip program participants with basic microfinance literacy and skills. In addition to conducting didactic sessions, CHVs also received additional training on conducting basic health interventions, such as taking vitals, assessing for hemorrhage and infections at the 48-hour postpartum home-visit, supporting mothers in exclusively breastfeeding, counselling participants on options for family planning, and adopting safe sleep practices. Throughout the year, CHVs attended regularly scheduled check-in meetings (at months 1-4, 6, 9, and 12) with implementation leads from the Chamas team to provide feedback, as well as receive additional mentorship and support.
Intervention description
We designed the Chamas program and curriculum in collaboration with the GOK and county-level MOH representatives to ensure the support and investment of local community members. The Chamas curriculum was designed by a diverse group including AMPATH researchers, community members, and local MOH representatives with the intent to: highlight evidence-based health interventions and topics delineated by international authorities (i.e. WHO), bolster training provided through the existing CHV handbook, and respond directly to the needs of and questions asked by the local community. Though the curriculum combines lessons from existing evidence-based curricula, this study served as a debut platform for our curriculum.
Women attending Chamas convened twice per month for 12 months to attend a total of 24 CHV-facilitated group health education and microfinance sessions. Each group was typically comprised of 15-30 women and each session consisted of a 60 to 90-minute participatory lesson on one health (i.e. antenatal care, family planning) and one social (i.e. intimate partner violence, microfinance literacy) topic (Table 1). Upon joining the program, women also agreed to practice key MNCH behaviors, namely to: deliver in a health facility, attend at least four ANC visits, EBF to six months, receive a CHV home visit within 48 hours of delivery, consider a long-term method of FP, ensure their infant received OPV0, and save money to finance health expenditures. We tasked each group with writing their own constitution in which they delineated additional individual goals for their own health and well-being.
Following lessons, members elected to participate in a table-banking program called “Group Integrated Savings for Health and Empowerment” (GISHE). GISHE is an adaptation of the Catholic Relief Services’ Savings and Internal Lending model, which encourages a savings-led, group-based microfinance scheme.28 We deemed participation optional to avoid excluding women that could not afford to contribute the minimum 50 KSH (0.50 USD) share per meeting. Members contributed up to ten times the amount of the minimal share at each Chamas session. The group provided loans that amounted to a multiple of the individual member’s savings and returned a dividend payment based on interest accrued at the end of the year. Profits generated were distributed to the entire group in amounts proportional to individual shares contributed.
In contrast to our intervention cohort, our control cohort received the current standard of care as delineated by the MOH (described under Community Health Volunteers in Kenya). As such, they received monthly, individual CHV household visit, but did not participate in structured, evidence-based health and microfinance education sessions or experience the group-based platform provided through the Chamas program.
Data collection and study variables
Data collection
We collected baseline and outcome data at two time-points for all participants using paper-based, structured questionnaires. We employed AMPATH research assistants trained in paper- and electronic-based data entry to collect data at both time-points. We recorded baseline data on participant sociodemographic and reproductive health information at study enrollment, and outcome data on uptake of MNCH interventions between 6-12 months postpartum for each participant. Where possible, we extracted data from Maternal and Child Health (MCH) booklets. If women did not have their MCH booklet available or if booklets missed data, we asked participants to self-report answers. Interview location differed depending on the participant’s cohort assignment. At baseline, we interviewed and collected data on intervention participants at health facilities on the day they enrolled. Conversely, we conducted baseline assessments on controls at their homes after identifying them from clinic registers. We collected end-line data from both the control and intervention cohorts at participant homes. During both baseline and end-line assessments, we made every effort to collect data individually and privately so as to minimize potential for response bias.
We additionally assessed maternal and infant morbidity and mortality using program monitoring data as well as group process outcomes (i.e. microfinance participation). CHVs collected program monitoring and evaluation data at each Chamas meeting using a paper-based log. CHVs reported data monthly to trained research assistants who electronically transcribed and uploaded outcomes to a protected database.
Dependent/outcome variables
Our primary outcome of interest was the proportion of women delivering in health facilities with an SBA. We defined SBA as a “health professional – such as a midwife, doctor, clinical officer or nurse.”2 This was a self-reported measure collected from a structured end-line questionnaire. Our secondary MNCH outcomes included: the proportion of women who attended at least four ANC visits, received a CHV within 48 hours postpartum, EBF to 6 months, adopted a long-term or permanent method of family planning, and the proportion of infants that received OPV0 at birth.
Though not powered to detect significant differences, we also assessed pregnancy-related morbidity and mortality outcomes including: the gestational age (GA) at delivery, the incidence of miscarriage (defined as loss of fetus less than 28 weeks gestation) and stillbirth (defined as loss of fetus between 28 weeks and delivery), as well as the incidence of infant and maternal mortality. Lastly, we assessed secondary outcomes related to microfinance participation within the Chamas cohort (i.e. proportion of Chamas members participating in GISHE, individual loans received, group savings accumulated).
Independent variables/covariates
To assess the modifying effect of covariates at the individual and group level, we collected sociodemographic and reproductive health information for all participants, including: age, education level, employment status, marital status, parity, prior facility delivery (among those who previously delivered), and facility location of first ANC visit. Maternal age may worsen maternal and fetal outcomes, increasing the propensity of older women to seek care or establish contact with health facilities earlier in pregnancy.29 Sociodemographic characteristics such as education level, employment status and marital status may impact the likelihood of facility delivery as these variables serve as proxies for socio-economic status. We defined “employment” as earning the national daily minimum wage of 450 Kenyan Shillings and allowed participants to self-report status by selecting a categorical descriptor (i.e. housewife/unemployed, self-employed, agricultural worker, other).26 Previous studies demonstrate women of lower socio-economic status or lower levels of education are less likely to deliver in facilities with an SBA.30 Further, reproductive health characteristics such as parity and prior facility delivery may positively or negatively impact a woman’s likelihood of returning to facilities, based on experiences with the health system.31,32 Lastly, we collected first ANC visit facility location to address potential area-level variance on the likelihood of facility delivery.
Sample size determination
To calculate our estimated sample size, we assumed 55% of women who attended at least one ANC visit delivered in a health facility and an intra-class correlation coefficient of 0.34, which accounts for population-level variance due to area-level effects (i.e. contact and proximity to the health system and CHVs, clustering by health facility catchment area).2,33 With these assumptions, we determined a 2:1 sample of 240 (156 Chamas and 84 Control) participants adequate to detect a 20% difference in the proportion of facility deliveries between intervention and control groups, with a type I error rate (α) of 0.05 and power of 85%. We assumed a 10% loss to follow-up and established a final target sample size of 267 total participants.
Data analysis
We tabulated frequencies and calculated descriptive statistics comparing socio-demographic and reproductive health variables between Chamas participants and controls. For all bivariate analyses, we used student’s T tests for continuous variables, Mann-Whitney U tests for continuous variables with non-normal distributions, two-sample Z-score tests for proportions, and Chi-square tests for categorical variables.
Multivariable nested models were used to test the association between Chamas participation and facility delivery independently, with successive inclusion of covariates namely: age, education level, employment status, marital status, parity, and prior facility delivery. We examined age as a continuous variable. We collapsed education level into a 3-level categorical variable (none-some primary, completed primary, some-completed secondary), and employment (unemployed vs. employed), marital status (single/separated/divorced vs. married), parity (primiparous vs. multiparous), and prior facility delivery into dichotomous variables. We performed complete case analyses and excluded records with missing data on the primary outcome variable or covariates.
Random effects models, employing the same nested-inclusion technique described above, tested for significant area-level variance as determined by prenatal care location. We additionally ran an interaction model with ANC attendance (dichotomous variable, <4 visits vs. ≥4 visits) and Chamas participation, as we hypothesized mothers attending at least four ANC visits were more likely to deliver in a health facility than those who attended fewer than four visits.32 We decided a priori to conduct an additional sensitivity analysis restricting our intervention sample solely to Chamas women who participated in GISHE to examine the impact of combined effect of health education and microfinance participation on MNCH intervention uptake. We conducted all statistical analyses using Stata version 13.1 (StataCorp, College Station, Texas) with α set to 0.05.
Ethical consideration
Our study received ethics approval from the Institutional Research Ethics Committee at Moi Teaching and Referral Hospital (IREC/2013/76), the Office of Research Administration at Indiana University (#1306011628), and the Research Ethics Board at the University of Toronto (# 2907). We obtained written informed consent from all participants prior to data collection.