PMID- 35459259 OWN - NLM STAT- MEDLINE DCOM- 20220426 LR - 20240214 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 23 IP - 1 DP - 2022 Apr 22 TI - Implementation and evaluation of a large-scale postpartum family planning program in Rwanda: study protocol for a clinic-randomized controlled trial. PG - 337 LID - 10.1186/s13063-022-06261-5 [doi] LID - 337 AB - 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. CI - (c) 2022. The Author(s). FAU - Wall, Kristin M AU - Wall KM AUID- ORCID: 0000-0001-8547-2004 AD - Department of Epidemiology, School of Public Health, Emory University, Atlanta, USA. kmwall@emory.edu. FAU - Ingabire, Rosine AU - Ingabire R AD - Projet San Francisco (PSF)/Center for Family Health Research (CFHR), Kigali, Rwanda. FAU - Mazzei, Amelia AU - Mazzei A AD - Projet San Francisco (PSF)/Center for Family Health Research (CFHR), Kigali, Rwanda. AD - Department of Pathology, School of Medicine, Emory University, Atlanta, USA. FAU - Umuhoza, Claudine AU - Umuhoza C AD - Projet San Francisco (PSF)/Center for Family Health Research (CFHR), Kigali, Rwanda. FAU - Parker, Rachel AU - Parker R AD - Department of Pathology, School of Medicine, Emory University, Atlanta, USA. FAU - Tichacek, Amanda AU - Tichacek A AD - Department of Pathology, School of Medicine, Emory University, Atlanta, USA. FAU - Nizam, Azhar AU - Nizam A AD - Department of Biostatistics and Bioinformatics, School of Public Health, Emory University, Atlanta, USA. FAU - Sales, Jessica M AU - Sales JM AD - Department of Behavioral, Social and Health Education Sciences, School of Public Health, Emory University, Atlanta, USA. FAU - Haddad, Lisa B AU - Haddad LB AD - Population Council, New York, USA. FAU - Corso, Phaedra AU - Corso P AD - Office of Research, Department of Health Policy, Kennesaw State University, Kennesaw, USA. FAU - Allen, Susan AU - Allen S AD - Department of Pathology, School of Medicine, Emory University, Atlanta, USA. FAU - Nyombayire, Julien AU - Nyombayire J AD - Projet San Francisco (PSF)/Center for Family Health Research (CFHR), Kigali, Rwanda. FAU - Karita, Etienne AU - Karita E AD - Projet San Francisco (PSF)/Center for Family Health Research (CFHR), Kigali, Rwanda. AD - Department of Pathology, School of Medicine, Emory University, Atlanta, USA. LA - eng SI - ClinicalTrials.gov/NCT05056545 GR - R01 HD101600/HD/NICHD NIH HHS/United States PT - Clinical Trial Protocol PT - Journal Article DEP - 20220422 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Ambulatory Care Facilities MH - *Contraception/methods MH - *Family Planning Services/methods MH - Female MH - Humans MH - Infant, Newborn MH - Male MH - Postpartum Period MH - Pregnancy MH - Program Evaluation MH - Randomized Controlled Trials as Topic MH - Rwanda PMC - PMC9027832 OTO - NOTNLM OT - Birth spacing OT - Contraception OT - Family planning OT - Implementation OT - Postpartum OT - Rwanda OT - Stepped-wedge randomized trial COIS- The authors declare that they have no competing interests. EDAT- 2022/04/24 06:00 MHDA- 2022/04/27 06:00 PMCR- 2022/04/22 CRDT- 2022/04/23 05:15 PHST- 2021/09/25 00:00 [received] PHST- 2022/03/31 00:00 [accepted] PHST- 2022/04/23 05:15 [entrez] PHST- 2022/04/24 06:00 [pubmed] PHST- 2022/04/27 06:00 [medline] PHST- 2022/04/22 00:00 [pmc-release] AID - 10.1186/s13063-022-06261-5 [pii] AID - 6261 [pii] AID - 10.1186/s13063-022-06261-5 [doi] PST - epublish SO - Trials. 2022 Apr 22;23(1):337. doi: 10.1186/s13063-022-06261-5.