Evaluating Public Sector Strengthening and Outreach Programs in Nigeria and the Democratic Republic of the Congo: Study Protocol for Five Parallel, Non-Blinded Cluster-Randomized Controlled Trials (Preprint)

BACKGROUND Large-scale family planning (FP) service-delivery programs are widely implemented in low- and middle-income countries but few have been evaluated using experimental designs. OBJECTIVE This protocol describes five cluster-randomized controlled trials that evaluate the impact of Marie Stopes International’s (MSI) Public Sector Strengthening (PSS) and Outreach programs, delivered under the Step-Up initiative, on modern contraceptive use and related reproductive health outcomes in selected settings of Nigeria (Niger and Kogi states) and the Democratic Republic of the Congo (DRC; Haut-Katanga province). METHODS We conduct five independent, non-blinded, community-level cluster-randomized controlled trials for PSS and Outreach interventions in each of Niger and Kogi states, and Outreach in Haut-Katanga. Clusters (sites) were randomized [1:1] to intervention or control following a baseline survey of women aged 15-49, with an 18-month intervention period and an endline survey of women in the same age range. The primary outcome is current modern contraceptive use, while preference-behavior alignment and facility-level quality of care are secondary outcomes. Each trial will be analyzed separately by estimating intention-to-treat (ITT) effects using generalized linear mixed models. RESULTS This study was funded in June of 2024. The protocol was reviewed by the IRB of the Johns Hopkins Bloomberg School of Public Health (#30810), the Comite d’Ethique at the School of Public Health at the University of Kinshasa in DRC (#ESP/CE/213/2024), the National Health Research Ethics Committee of Nigeria (NHREC) (#NHREC/01/01/2007-14/03/2025), and internally at MSI. CONCLUSIONS This study will provide a rigorous assessment of the impact of family planning programs on a range of outcomes. Results will be shared with the country officials, presented at international and national conferences, and published in peer-reviewed journals CLINICALTRIAL The trial was registered at the American Economic Association’s (AEA) registry for randomized controlled trials. Trial registration number: AEARCTR-0018907