Family Planning Clinical Trial
Official title:
Implementation and Evaluation of a Large-scale Postpartum Family Planning Program in Rwanda
This trial wants to address high unmet need for postpartum family planning (PPFP) in Rwanda. A previous pilot study tested the intervention (informed by formative work with couples/clients, clinic providers, champions, and community health workers), which significantly increased the use of PPFP in government clinics. This study now proposes to use an implementation science framework to test the hypothesis that the proposed PPFP intervention is adaptable to large-scale implementation, cost-effective, and sustainable. This PPFP could dramatically reduce unintended pregnancy and abortion and improve birth spacing and maternal and newborn health.
Status | Recruiting |
Enrollment | 26215 |
Est. completion date | March 31, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Eligible PPFP promoters will be government facility providers working in ANC,L&D, IV and/or postpartum services at one of the study facilities. - Eligible PPFP providers will be government facility providers working in L&D, and/or family planning services at one of the study facilities. - Eligible Happy Client promotors will be postpartum women who received promotions and selected a PPFP method. - Eligible nurse/midwife and CHW promotors will be women working as nurses or CHWs at one of the intervention facilities. - All women eligible for PPFP services in this study will be at any stage of pregnancy or up to 14 weeks postpartum, and receiving antenatal care (ANC), L&D, IV, or postpartum services at one of the intervention or pilot facilities Exclusion Criteria: - Prisoners |
Country | Name | City | State |
---|---|---|---|
Rwanda | Project San Francisco, Kigali | Kigali | Kigali Province |
Lead Sponsor | Collaborator |
---|---|
Emory University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Rwanda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numbers of clinic directors engaged | Numbers of clinic directors engaged to provide the PPFP Intervention | Through study completion, an average of 3 years | |
Primary | Number of Nurses trained to promote PPFP | The number of nurses who complete PPFP intervention session to promote PPFP use | After completion of a 2-day training | |
Primary | Number of CHWs trained to promote PPFP | The number of CHWs who complete C4 training session to promote PPFP use | After completion of a 2-day training session | |
Primary | Number of providers trained to provide PPFP | Nurses and midwives working labor and delivery and family planning will attend a 2-day didactic training session. Providers will complete a post-training test consisting of 10 true or false questions. Those who do not score at least 80% on the post-training test will be offered re-training after one week. | After completion of a 2-day training session | |
Primary | Number of providers certified to provide PPFP | After completing the didactic training, providers will have the opportunity to become certified, by correctly inserting 5 PPIUDs and 5 PP implants under supervision. | After completion of a 2-day training session | |
Primary | Number of promotions to pregnant or postpartum women/couples | The number of pregnant or postpartum women/couples receiving one-on-one C4 counseling | Beginning at the first antenatal care visit up to post-partum week 14 (up to 54 weeks) | |
Primary | Number of PPIUD insertions | The number of postpartum women who opt to have a PPIUD inserted | Up to postpartum week 14 | |
Primary | Number of PP implant insertions | The number of postpartum women who opt to have a PP implant inserted. | Up to postpartum week 14 | |
Secondary | Cost-effectiveness/cost-utility: Couple Years Protection (CYP) | Cost, in US dollars adjusted for the year of data analysis per CYP | Years 2 and 4 of the project period | |
Secondary | Cost-effectiveness/cost-utility: Cost per Quality Adjusted life years (QALY) | Cost, in US dollars adjusted for the year of data analysis of cost per QALY saved | Years 2 and 4 of the project period |
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