A cluster randomized, controlled trial assessing the effect of IPTp administration by CHWs (compared to the routine practice of delivering IPTp at health facilities) on the coverage of IPTp and ANC was conducted in three districts of Burkina Faso over 15 months, from May 2017 to August 2018, with baseline and post-intervention surveys carried out in March 2017 and July–August 2018, respectively.
With an estimated population of 20 million, Burkina Faso is a high malaria endemic Sahelian country in the heart of West Africa accounting for 4% of the world’s annual malaria cases . Women comprise 51.8% of the overall population, and it is expected that 5.5% of women will be pregnant at any given time . The study was implemented in three of the 13 regions (Sud-Ouest [South-West], Centre-Sud [Central-South], and Centre-Est [Central-East]) with highest malaria transmission. One district was purposively selected from each of the three regions, taking into account malaria epidemiology, IPTp coverage, and the presence of active CHWs (Fig. 1). Routine HMIS data indicate that before the trial, IPTp3 coverage in the selected districts, Batié, Pô, and Ouargaye, was 34.6%, 52.8%, and 47.2%, respectively, for an overall average of 44.9%.
Non-contiguous health facilities (HF) in each district were matched by estimated general population and estimated number of pregnant women and IPTp2 coverage (based on routine health facility data). In each district, two pairs of HFs were purposively selected, and one HF in each pair was randomly assigned to the intervention, for a total of 12 HFs (six intervention, six control) (Table 1).
The study intervention included all pregnant women living in the targeted areas, while the baseline and endline surveys included women aged 18-49 years in selected households who had given birth in the nine months prior to each survey. The catchment area of these HFs included 113 villages, all of which were included in the cross-sectional survey, with sample size per village selected proportional to village size. At the village level, the Expanded Programme on Immunization (EPI) sampling method was used to select households where women would be interviewed . At the center of the village, a direction was chosen by spinning a bottle on the ground. Households along the indicated path were visited and the questionnaire was administered to consenting, eligible women until the desired sample size was achieved.
A sample size of 360 women (30 women per health facility catchment area) who had delivered in the last nine months was required for each survey to achieve 80% power to detect a difference between the group proportions of approximately 19.6%, from a baseline proportion of 44.7% (average proportion in the three districts) to an endline proportion of 64.3% in the intervention arm, as estimated using PASS V14 (NCSS, LLC, Kaysville, UT) to assess sample size for cluster randomized trial, at a significance level of 0.05 and assuming an intra-cluster correlation (ICC) of 0.03.
The CHW registers were designed to provide a reminder that IPTp should be given monthly, and not more frequently, and to help the CHW reconcile who needed follow-up. Existing male CHWs were paired with female volunteers (“animatrices”), to ensure that home visits were only conducted by women, as there was concern that it would not be culturally acceptable for male CHWs to enter the homes and speak to pregnant women. If the female volunteer was not literate, the male CHW in that village assisted her in completing the forms, and at times accompanied her on the home visit. Formal CHWs received approximately $35USD monthly from the government as compensation for their duties; female volunteers recruited by the study received the same amount in monthly compensation from the study.
The MOH ensured the availability of SP tablets/treatment for IPTp in both control and intervention HFs throughout the study, including for distribution by trained CHWs. Each pregnant woman seen at ANC in the intervention facility received information on the community IPTp study and had the choice to participate or not. Pregnant women who wanted to receive SP had their identities recorded on a summary sheet and in CHW registers to facilitate their follow-up for the intervention. Women were asked to follow-up with the CHW monthly; those who did not present for the scheduled visit with the CHW were followed at home. The first dose of IPTp-SP was always given as directly observed therapy (DOT) at the HF to ensure that a health provider confirmed the woman’s gestational age and initiated IPTp after the end of the first trimester. CHWs also provided IPTp-SP as directly observed therapy, as part of their monthly household visits starting with the second dose, provided that SP had not been administered in the preceding four weeks. This was then recorded on the woman’s ANC card, which had space for recording up to five doses. CHWs also encouraged women to attend ANC, collected data on any adverse events, and referred women to the facility in the case of adverse events. CHW data were collected monthly. CHWs were supervised monthly by HF workers; monthly meetings were facilitated by the study.
Activities were implemented using the cascade training approach. The first training session included central-level stakeholders (National Malaria Control Program, Directorate of Family Health, Directorate for Health Promotion and Education, Directorate of Sectorial Statistics) and the field coordinator from each district. The main objective of this training was to orient stakeholders on the organization and use of the various intervention tools. The stakeholder then transferred the information to the HF health workers, who in turn trained the CHWs (33 existing male and 25 existing female CHWs plus an additional 33 female volunteers).
For each survey, ten people were trained over two days in each district, and eight were chosen as field data collectors. The trainings focused on mastery of data collection tools, ethical rules, and ensuring data quality. CHWs and HF workers were trained on potential adverse events related to SP administration and instructed to report any adverse events to the study coordinator.
Routine service data (ANC visits, IPTp doses delivered by CHWs and at the HF) were summarized monthly to monitor the intervention. The primary outcome was the change in IPTp3 coverage over time assessed using a difference in difference analysis comparing the baseline and endline cross sectional survey data. In addition, a descriptive analysis of the socio-demographic characteristics of women included in the baseline and endline surveys, stratified by intervention and control areas, was performed. The REG procedure in SAS was used to assess for differences in medians. Difference in differences analyses were conducted on the survey data to assess the change over time in additional secondary outcomes, including any ANC visits (ANC1), four or more ANC visits (ANC4), IPTp1, 2, 4, and 5 coverage. Both primary and secondary outcomes were based on what was recorded on the ANC card, up to a maximum of five IPTp doses. The analyses used logistic regression with generalized estimating equations with the GENMOD procedure in SAS Version 9.4 (SAS Institute Inc., Cary, NC) for binary outcomes (ANC1, ANC4, IPTp3, IPTp4) with difference in differences calculated using a binary model with an identity link function, and Poisson regression for continuous outcomes (number of IPTp doses, number of ANC visits, timing of initiation of ANC). This was done by incorporating an intervention group variable, a variable indicating pre- or post-intervention, and an intervention-time interaction term. The ICC was calculated using the same model with the “corrw” option in the repeated statement. In order to obtain 95% confidence intervals (95%CI) for the difference in differences, a linear model was run using the GENMOD procedure, including all the same terms as in the logistic model. All analyses accounted for clustering at the HF level. Maternal age and gravidity were included a priori in the model; district and maternal education were explored as covariates but dropped due to lack of significance. A p-value of less than 0.05 was considered statistically significant.
The protocol was reviewed and approved by the John’s Hopkins School of Public Health (JHSPH) and Burkina Faso Institutional Review Boards (IRB); the Centers for Disease Control and Prevention Human Subjects Office determined that CDC staff were not engaged in human subjects research. Verbal informed consent was obtained from each woman in the local language prior to data collection.