We conducted a complex, multicentre, randomized cluster trial called Yam Daabo in primary health centers in the Yako health district (Centre-North region, BF).
BF is a sub-Saharan African country, with an estimated population of 20,321,000 in 2019 . According to Blumenberg et al., the modern contraceptive prevalence rate (MCPR) was 31.9% in December 2018, based on the analysis of Performance Monitoring and Accountability 2020 (PMA2020) data . Ahmed et al., using the FP 2020 data, reported an estimated unmet need for modern contraception of 27.2% in 2017 . As in most countries in sub-Saharan Africa, cultural norms favor large families, with higher fertility rates in rural areas than in urban areas. In 2019, BF had 5.6 live births per woman .
Description of the Yam Daabo trial:
This study involved two countries: BF and the DRC. The project was implemented in several successive phases: pre-formative phase, formative phase, and intervention phase. We randomized each country's health centers into two groups during the intervention phase: intervention and control. The health centers in the experimental group offered six PPFP interventions that were identified as solutions to the barriers identified during the formative phase of the project and are already described in another article . The health centers in the control group offered the usual PPFP care. We included and followed women at the third trimester of their pregnancy over 12 months after delivery. As said above, Yam Daabo's interventions comprised refresher training for the provider, counseling tool, supportive supervision, availability of contraceptive services 7 days a week, client appointment cards, and invitation letters for partners. Participants received individual-based interventions during their pregnancy and during the postpartum period, according to national practice (typically on clinical discharge [24 − 48 h], at 6 days, 6 weeks, then at months 6 and 9, before the trial exit at month 12 postpartum). The study was statistically powered to detect a difference of 15 percentage points between the experimental and control groups in the proportion of women adopting an effective method of PPFP at 6 months postpartum. Considering the intra-cluster correlation coefficient, in each country, each study group had to have 4 health centers with at least 60 participants per centre to have a statistical power of 93% at a significance level of 5%. As this study had an estimated loss to follow-up rate of 10%, each center had to recruit at least 70 pregnant women. This value was equivalent to a cohort of 280 pregnant women in each group (4 centers × 70 participants) and a total of 560 participants per study and country (280 participants × 2 study groups). All pregnant women were eligible to participate in the study if (1) they were in their third pregnancy trimester; (2) the status of the pregnancy and the woman allowed for a birth at the health center; (3) the woman had the intention to attend ANC, delivery, and PNC at the health center; (4) the woman did not participate in another study; and (5) we obtained informed consent. Research assistants collected data on paper-based case report forms (CRFs). The WHO team in Geneva developed the CRFs with inputs from the country's research teams. Each health center of the cluster RCT had a research assistant who was trained to adhere to the study manual and standard operating procedures for data management, which are common to both study countries and have been developed by WHO. The information reported on the CRFs was checked for accuracy and completeness several times at different levels by field coordinators and data managers. The Biostatistics and Data Management team at HRP developed the eCRF through OpenClinica (version 3.11), an electronic data capture software for clinical research. This software allowed checks for data accuracy, completeness, and consistency, reducing data queries, and problem resolution delays. In each country, the eight sites were matched by pairs according (1) the average number of deliveries per month, (2) the ratio of health workers per population, and (3) the settings (rural, urban). Within each pair, we randomly selected the site assigned to the experimental intervention. This randomization was done four times. No restriction in the randomization process was required. All consecutive and eligible participants were included in the clusters. Due to the nature of the interventions, participants, health staff, research assistants assigned to each centre, and the rest of the research team members could not be masked to the cluster assignments. Methodological details on the Yam Daabo are available in the published protocol .
The trial was approved by the WHO Ethics Committee and the Health Research Ethics Committee of BF and has been registered in the Pan-African Clinical Trials Registry (registration number: PACTR201609001784334 on 27/09/2016).
No interim analysis was conducted during this study. At the end of the 12-month follow-up, analyses on contraceptive use at each of the contact points (day 6, week 6, month 6, and month 12) were conducted. These results for BF and the DRC have already been published [5, 6].
The time from enrolment to exit interview at 24 months postpartum spanned from July 27, 2016, to November 15, 2018.
Type of study
We conducted a randomized, clustered, controlled trial extending the follow-up of women to 24 months (12 months after the end of the interventions).
we included in this study all postpartum women who participated in the Yam Daabo trial.
Additional collection period
we collected data from September 15, 2018, to November 15, 2018.
The primary outcome of this study was the contraceptive method use. We used the classification adopted by the WHO in 2015 . Thus, for this analysis, the groups of methods were defined as follows
- Long-acting reversible contraceptive, including implants and intrauterine devices
- Short-acting contraceptive methods, including injectables, pills, emergency contraception, male and female condoms
- Permanent methods (male and female sterilization)
- The lactational amenorrhea method
Next, we also classified the contraceptive methods into "modern and appropriate methods" and "non-modern or inappropriate methods." The non-modern methods comprised traditional methods, withdrawal, and abstinence. Inappropriate methods include lactational amenorrhea (if used after 6 months) and calendar-based methods (if used during the first 12 months postpartum).
The main dependent variable was exposure to interventions, defined as the binary variable (coded 1 for the intervention group and 0 for the control group).
Moreover, we measured the frequency of pregnancies in both groups of women.
Data collection at 24 months postpartum
five interviewers collected the data (They were part of the interviewing team that collected follow-up data up to 12 months postpartum). To locate the target participants, they used the women's identification documents, which contained their telephone numbers. Maternity health workers and community-based health workers provided valuable assistance in the search for women. They conducted interviews mainly in health centers and women's homes or other secure public places chosen by the woman beforehand. Data on contraception use were extracted into the health centers registers.
Data processing and statistical analysis
EpiData and Stata 15.1 software were used for data entry and analysis, respectively. To ensure the comparability of results with published data on intervention effectiveness at 12 months postpartum, we used generalized linear mixed-effects (log Poisson) models were used to measure the effects of interventions on contraceptive use with a significance threshold of 5%. We adjusted the measure of association on sociodemographic variables unequally distributed between the intervention and control groups, at inclusion. We also corrected for a possible cluster effect by taking into account any correlation that might exist.
We followed Consolidated Standards of Reporting Trials extension for pragmatic trials guidelines to write the manuscript (supplementary file 1).
The study protocol was approved by the Health Research Ethics Committee of BF. Participants' data were anonymized, and informed consent was obtained from all women prior to data collection.