Currently submitted to: JMIR Research Protocols
Date Submitted: Nov 4, 2026
Open Peer Review Period: Nov 5, 2026 - Dec 31, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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
ABSTRACT
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 Clinical Trial: The trial was registered at the American Economic Association’s (AEA) registry for randomized controlled trials. Trial registration number: AEARCTR-0018907
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