Implementation and evaluation of a large-scale postpartum family planning program in Rwanda: study protocol for a clinic-randomized controlled trial

• Type of Material: Article
• Authors: Kristin Wall, Emory University; Rosine Ingabire, Center for Family Health Research (CFHR); Amelia Mazzei, Center for Family Health Research (CFHR); Claudine Umuhoza, Center for Family Health Research (CFHR); Rachel Parker, Emory University; Aamanda Tichacek, Emory University; Azhar Nizam, Emory University; Jessica Sales, Emory University; Lisa Haddad, Emory University; Phaedra Corso, Kennesaw State University; Susan Allen, Emory University; Julien Nyombayire, Center for Family Health Research (CFHR); Etienne Karita, Center for Family Health Research (CFHR)
• Language: English
• Date: 2022-04-22
• Publisher: BMC
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2022
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s13063-022-06261-5
• Title of Journal or Parent Work: TRIALS
• Volume: 23
• Issue: 1
• Start Page: 337
• End Page: 337
• Grant/Funding Information: National Institutes of Health, NICHD, R01HD101600. The funding body has no role in the design of the study; collection, analysis, or interpretation of the data; or writing of the manuscript.
• Keywords: Research & Experimental Medicine; HEALTH; HIV; Stepped-wedge randomized trial; Postpartum; Family planning; Life Sciences & Biomedicine; Medicine, Research & Experimental; Science & Technology; Rwanda; Contraception; Birth spacing; COUPLES; Implementation
• Research Categories: Health Sciences, Epidemiology; Health Sciences, Pathology; Biology, Biostatistics

Abstract

Background: Though the Rwandan Ministry of Health (MOH) prioritizes the scale-up of postpartum family planning (PPFP) programs, uptake and sustainability of PPFP services in Rwanda are low. Furthermore, highly effective long-acting reversible contraceptive method use (LARC), key in effective PPFP programs, is specifically low in Rwanda. We previously pilot tested a supply-demand intervention which significantly increased the use of postpartum LARC (PPLARC) in Rwandan government clinics. In this protocol, we use an implementation science framework to test whether our intervention is adaptable to large-scale implementation, cost-effective, and sustainable. Methods: In a type 2 effectiveness-implementation hybrid study, we will evaluate the impact of our PPFP intervention on postpartum LARC (PPLARC) uptake in a clinic-randomized trial in 12 high-volume health facilities in Kigali, Rwanda. We will evaluate this hybrid study using the RE-AIM framework. The independent effectiveness of each PPFP demand creation strategy on PPLARC uptake among antenatal clinic attendees who later deliver in a study facility will be estimated. To assess sustainability, we will assess the intervention adoption, implementation, and maintenance. Finally, we will evaluate intervention cost-effectiveness and develop a national costed implementation plan. Discussion: Adaptability and sustainability within government facilities are critical aspects of our proposal, and the MOH and other local stakeholders will be engaged from the outset. We expect to deliver PPFP counseling to over 21,000 women/couples during the project period. We hypothesize that the intervention will significantly increase the number of stakeholders engaged, PPFP providers and promoters trained, couples/clients receiving information about PPFP, and PPLARC uptake comparing intervention versus standard of care. We expect PPFP client satisfaction will be high. Finally, we also hypothesize that the intervention will be cost-saving relative to the standard of care. This intervention could dramatically reduce unintended pregnancy and abortion, as well as improve maternal and newborn health. Our PPFP implementation model is designed to be replicable and expandable to other countries in the region which similarly have a high unmet need for PPFP. Trial registration: ClinicalTrials.gov NCT05056545. Registered on 31 March 2022.