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Introduction Community-based women’s health education groups may improve maternal, newborn and child health (MNCH); however, evidence from sub-Saharan Africa is lacking. Chamas for Change (Chamas) is a community health volunteer (CHV)-led, group-based health education programme for pregnant and postpartum women in western Kenya. We evaluated Chamas’ effect on facility-based deliveries and other MNCH outcomes. Methods We conducted a cluster randomised controlled trial involving 74 community health units in Trans Nzoia County. We included pregnant women who presented to health facilities for their first antenatal care visits by 32 weeks gestation. We randomised clusters 1:1 without stratification or matching; we masked data collectors, investigators and analysts to allocation. Intervention clusters were invited to bimonthly, group-based, CHV-led health lessons (Chamas); control clusters had monthly, individual CHV home visits (standard of care). The primary outcome was facility-based delivery at 12-month follow-up. We conducted an intention-To-Treat approach with multilevel logistic regression models using individual-level data. Results Between 27 November 2017 and 8 March 2018, we enrolled 1920 participants from 37 intervention and 37 control clusters. A total of 1550 (80.7%) participants completed the study with 822 (82.5%) and 728 (78.8%) in the intervention and control arms, respectively. Facility-based deliveries improved in the intervention arm (80.9% vs 73.0%; risk difference (RD) 7.4%, 95% CI 3.0 to 12.5, OR=1.58, 95% CI 0.97 to 2.55, p=0.057). Chamas participants also demonstrated higher rates of 48 hours postpartum visits (RD 15.3%, 95% CI 12.0 to 19.6), exclusive breastfeeding (RD 11.9%, 95% CI 7.2 to 16.9), contraceptive adoption (RD 7.2%, 95% CI 2.6 to 12.9) and infant immunisation completion (RD 15.6%, 95% CI 11.5 to 20.9). Conclusion Chamas participation was associated with significantly improved MNCH outcomes compared with the standard of care. This trial contributes robust data from sub-Saharan Africa to support community-based, women’s health education groups for MNCH in resource-limited settings. Trial registration number NCT03187873.
We conducted a two-arm cluster randomised controlled trial in 74 community health units (CUs) across four subcounties (Cherangany, Kwanza, Kiminini and Saboti) in Trans Nzoia County, Western Province, Kenya (figure 1). Figure 1 depicts these 74 CUs allocated to control and intervention trial arms. Cluster randomisation was used to avoid potential contamination of intervention activities between neighbouring villages. Additional study details are available in our trial protocol (online supplemental trial protocol). We obtained written informed consent from all participants prior to data collection. We adhered to Consolidated Standards of Reporting Trials guidelines for reporting results of cluster randomised controlled trials (online supplemental CONSORT checklist). Cluster map. bmjgh-2020-003370supp001.pdf bmjgh-2020-003370supp002.pdf We identified 77 CUs among 163 total CUs across our four selected subcounties in Trans Nzoia to serve as potential clusters. CUs are geographically defined health service delivery areas, 5–8 km2 in size, for populations of 5000 people supervised by Community Health Extension Workers (CHEWs) and CHVs. CHEWs and CHVs connect CUs with their assigned health facilities (or ‘link facilities’), extending services traditionally based at facilities to the household level. CHVs are nominated members of their communities who serve as liaisons between community members and the health sector. CHEWs are salaried frontline health workers responsible for supervising CHVs. CUs selected for this trial were specifically chosen as their CHVs received formal CHS training from AMPATH. We recruited participants from 60 public and private health facilities linked to our 77 identified CUs. Pregnant women who were less than or equal to 32 weeks gestation, presenting for their first antenatal care (ANC) visits and residing in one of the 77 CUs were eligible. Among 77 identified CUs, 74 were represented by women deemed eligible for participation. We selected a gestational age cut-off of 32 weeks as the majority (96.0%) of Kenyan women who seek ANC at any point during pregnancy present for at least one ANC visit by this time.1 Due to slow recruitment resultant of preceding health worker strikes in Trans Nzoia, we increased our original gestational cut-off from 28 to 32 weeks. We randomised CUs selected to serve as clusters 1:1 to intervention (eg, Chamas programme) or standard of care (eg, monthly CHV home visits). The trial data manager used a simple random allocation sequence generated by PASS V.11.0.10) to designate cluster assignment. Non-study CUs (ie, those not randomised in this trial) served as buffer zones between intervention and control clusters to avoid contamination. There was no stratification or matching. We masked data collectors (trained AMPATH research assistants), investigators and analysts to cluster allocation throughout the trial; however, both arms were identifiable to participants and CHVs by design. Data collectors assessed women for eligibility at their first ANC visit. Women deemed eligible and willing to participate provided consent to be contacted for enrolment. The data manager generated lists of participants organised by residential CUs. These lists were subsequently distributed to CHVs who were tasked with finding women in their respective CUs and enrolling them. Data collectors accompanied CHVs during this process and obtained baseline data at enrolment. One week following the end of the enrolment period, the data manager randomised all CUs to intervention and control arms. Three weeks later, CHVs began facilitating Chamas in intervention clusters. Intervention clusters participated in the Chamas programme (programme details are published elsewhere).15 Briefly, Chamas is a group-based, CHV-led health education programme that supports women during the first 1000 days of their child’s life. Women randomised to the intervention arm participated in Chamas in lieu of receiving individual home visits (standard of care). Participants attend 60–90 min sessions two times a month, which include discussions on health and social topics relevant to antenatal, postpartum and early childhood experiences. CHVs use an illustrated flip chart with evidence-based, structured discussion guides to facilitate lessons. Groups are typically comprised of 15–20 women, two CHV facilitators and two mentor mothers (eg, postmenopausal women who have completed child rearing). The first year of the curriculum promotes behaviours associated with demonstrated reductions in maternal and infant morbidity and mortality. These lessons purposefully mirror health topics that CHVs are expected to promote during home visits under the CHS. Following each lesson, women are invited to participate in an optional table-banking programme called Group Integrated Savings for Health and Empowerment (GISHE). GISHE participation is optional so as not to deter women without financial means to contribute to group savings from joining Chamas. Women are encouraged to use savings generated by GISHE to finance health interventions (eg, enrol in health insurance, pay for transportation to health facilities), invest in early childhood education and/or start small businesses. Strategies to ensure fidelity of Chamas included: using standardised intervention materials (ie, printed curriculum flipcharts), hosting structured CHV training sessions preceding the trial, offering monthly supervision by study staff and designating at least two trained CHVs to every group to avoid potential disruptions due to illnesses or job transfers. In addition to attending the 4-day MNCH refresher training, CHVs facilitating Chamas also received a formal 2-day orientation to the programme and were trained in group facilitation techniques. We provided scheduled support sessions for CHV facilitators throughout the trial (during months 1–3, 6, 9 and 12), which provided opportunities for feedback and communal troubleshooting to enhance programme delivery. Control clusters had monthly CHV home visits during pregnancy and postpartum, as recommended by the Kenyan CHS standard of care.10 During monthly visits, CHVs collect basic health information, identify antenatal and early postpartum danger signs, refer individuals to care and aid in infant growth monitoring. CHVs are also expected to encourage women to adopt the same key health behaviours promoted in Chamas. CHVs working within control clusters received oversight and supervision from CHEWs, as structured by the CHS. CHVs performing door-to-door visits typically oversee a catchment of 15 women who are each visited for 20–30 min on a monthly basis (up to 7.5 hours per month). Those facilitating Chamas substituted door-to-door visits with group sessions; as such, their volunteer effort was reduced to two 60–90 min sessions per month (up to 3 hours per month). We did not provide incentives (monetary or other) for participation to CHVs, CHEWs or participants in either study arm at any point during the trial. CHEWs continued to receive salaries from the MOH and CHVs, who volunteer in addition to participating in other jobs (ie, as teachers, farmers, labourers), continued to work throughout the trial. Notably, CHVs under the current CHS are not financially compensated for performing door-to-door visits. To reduce potential for confounding, we similarly did not compensate CHVs for facilitating Chamas meetings. We did, however, reimburse all CHVs and CHEWs for travel to meetings and trainings as well as for air-time used to contact participants during recruitment. We measured outcomes at the individual level. We selected facility-based delivery as our primary outcome because of the significant association between institutional delivery and reductions in maternal and infant morbidity and mortality.16–18 Secondary outcomes included: attending adequate ANC (defined as attending at least four visits per Republic of Kenya MOH guidelines), receiving a 48-hour postpartum home visit, exclusively breastfeeding for 6 months, adopting a modern contraceptive method, immunising infants with the oral polio vaccine within 2 weeks postpartum, immunising infants with the measles vaccine (measles I) by 12 months of age and completing the infant immunisation series per WHO and Republic of Kenya MOH standards by 12 months of age.19–21 We additionally collected detailed microfinance data as well as validated questionnaire data on perceived levels of peer support and financial empowerment, which we plan to report in future articles. Data collectors travelled to participant homes to collect end-line data 12 months following the initiation of Chamas sessions and home visits. Outcome measures were self-reported with the exception of infant immunisations, which were extracted from standard MOH Maternal Child Health Booklets kept by mothers. All data were recorded using electronic, standardised questionnaires. We classified participants as lost to follow-up after we made three attempts to establish contact over a 2-week period. We conducted abbreviated phone surveys if participants relocated outside of Trans Nzoia County; these abbreviated questionnaires omitted questions on infant immunisations. At enrolment, we collected baseline participant sociodemographic (age, marital status, maternal education, occupation, poverty probability index scores, insurance status) and reproductive health (previous pregnancy and related outcomes) data. We used the Kenya 2015 Poverty Probability Index (PPI) questionnaire and national poverty line scorecard to estimate participants’ poverty likelihood at baseline.22 We recorded attendance at each Chamas session to track individual programme participation. A Data and Safety Monitoring Board recorded and investigated adverse events including CHV-reported participant mortalities as well as the cause of death (if known). We estimated sample size using methods described by Rutterford et al for a proposed mixed effects regression analysis23 using derived baseline estimates.1 15 Assuming a mean cluster size of 20 individuals, 77 clusters (equally allocated between arms), intracluster correlation coefficient (ICC) of 0.44 (based on pilot data)15 and 20% attrition, we calculated that a total of 1280 individuals would be needed to detect a 4.7% risk difference (RD) (difference in the rate of facility-based birth at the county vs national-level1 with 80% power at a (two-tailed) significance level of 0.05). To determine our recruitment timeline, we assumed 6.3% of all women of reproductive age would be pregnant at any given time (or roughly 50 women per CU annually).1 We determined an enrolment period of roughly 3–4 months adequate to recruit our estimated sample size. Our primary analyses were intention-to-treat (ITT) and included all participants from randomised clusters who provided baseline and 12-month follow-up data, regardless of the level of participation in Chamas. We summarised all demographic and reproductive health history information between arms with means and SDs as well as medians and IQRs for continuous variables and counts and percentages for categorical variables. We analysed the primary outcome with multilevel logistic regression with a random intercept for cluster, and effects are presented as RDs with 95% bootstrap CIs and ORs with 95% Wald-type confidence intervals and p values. We also report the ICC. We analysed secondary outcomes similarly. For both primary and secondary outcomes, we conducted several sensitivity analyses. First, to assess the impact of missing outcomes due to loss to follow-up, we used multiple imputation with 10 data sets with the ‘jomo’ algorithm to account for the multilevel structure of the data; results were then combined using Rubin’s rules.24 25 Second, to assess the possible impact of differences in factors known to be associated with care-seeking behaviours between arms, we adjusted our primary models for PPI score, marital status, null parity and health insurance at time of delivery. A third sensitivity analyses combined adjustment and imputation. Finally, we performed a sensitivity analysis restricting our intervention sample to women who attended at least one Chamas session during the trial period. We assessed the effect of Chamas participation on infant vaccination outcomes similarly, but given the large amount of missing data, no sensitivity analyses with imputation were conducted. Adjusted models for vaccination included maternal education, PPI and insurance at delivery as previous studies demonstrate strong associations between these sociodemographic factors and immunisation adherence.26 Further, since vaccination data were missing in approximately 40% of the sample, we were concerned about selection bias in those reporting the outcome. To account for this, we carried out an additional sensitivity analysis to indicate the amount of unmeasured confounding between trial arm and vaccination that would be needed to explain away the observed differences.27 There were no interim analyses. We developed, finalised and signed a statistical analysis plan prior to beginning data analysis [online supplemental statistical analysis plan]. Statistical significance was set at 0.05 and all analyses were conducted using R statistical software (V.3.5.3).28 bmjgh-2020-003370supp003.pdf We sought and incorporated feedback from a multidisciplinary study advisory committee including direct beneficiaries (ie, participating women, CHVs) and key stakeholders (ie, local community leaders, Kenyan MOH representatives) in the initial design and conception of this trial. We designed our questionnaires, data instruments and intervention activities based on qualitative feedback provided by programme participants during Chamas pilot studies. These qualitative questionnaires captured participant perceptions of the strengths and weaknesses of the programme as well as priority areas for continued improvement. Prior to initiating trial activities, we invited CHVs, CHEWs, health facility managers, subcounty MOH representatives and community leaders to stakeholder meetings to explain the study’s purpose and procedures as well as to facilitate understanding of our trial objectives among leadership at the county, subcounty and community levels. Following these meetings, we asked community leaders for permission to begin enrolling participants. All CHVs who agreed to participate also attended a 4-day refresher training on their roles and expectations in promoting MNCH under the Kenyan CHS. We discussed the trial’s risks and benefits with all participants before enrolment, including demands on individual time due to programme participation and data collection. We obtained written informed consent from all participants prior to data collection. At the trial’s conclusion, we verbally disseminated our preliminary findings to the programme’s direct beneficiaries and key stakeholders. We plan to additionally distribute printed summaries of key findings following the trial’s publication. The funders had no role in the research design, collection, analysis or interpretation of data, writing this report or the decision to submit this manuscript for publication. The corresponding author had full access to all data in the study as well as final responsibility for the decision to submit this manuscript for publication.
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