Department of Epidemiology, School of Public Health, Emory University, Atlanta, USA.
Projet San Francisco (PSF)/Center for Family Health Research (CFHR), Kigali, Rwanda.
Trials. 2022 Apr 22;23(1):337. doi: 10.1186/s13063-022-06261-5.
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.
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.
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.
ClinicalTrials.gov NCT05056545 . Registered on 31 March 2022.
尽管卢旺达卫生部（MOH）优先扩大产后计划生育（PPFP）项目的规模，但卢旺达的 PPFP 服务的利用率和可持续性仍然很低。此外，在卢旺达，高效长效可逆避孕方法（LARC）的使用特别低，而这是有效 PPFP 项目的关键。我们之前曾试点测试过一项供需干预措施，该措施显著增加了卢旺达政府诊所产后使用 LARC（PPLARC）的数量。在本方案中，我们使用实施科学框架来测试我们的干预措施是否具有适应性、成本效益和可持续性。
在 2 型有效性-实施混合研究中，我们将在卢旺达基加利的 12 个高容量卫生设施中进行诊所随机试验，评估我们的 PPFP 干预措施对产后 LARC（PPLARC）使用率的影响。我们将使用 RE-AIM 框架评估这项混合研究。将估计每个 PPFP 需求创造策略对在研究设施中分娩的产前诊所就诊者中 PPLARC 使用率的独立有效性。为了评估可持续性，我们将评估干预措施的采用、实施和维持情况。最后，我们将评估干预措施的成本效益，并制定国家实施计划。
在政府设施内的适应性和可持续性是我们提案的关键方面，MOH 和其他当地利益相关者将从一开始就参与其中。我们预计在项目期间将为 21000 多名妇女/夫妇提供 PPFP 咨询服务。我们假设该干预措施将显著增加参与的利益相关者数量、接受培训的 PPFP 提供者和促进者数量、接受 PPFP 信息的夫妇/客户数量以及与标准护理相比的 PPLARC 使用率。我们预计 PPFP 客户满意度将很高。最后，我们还假设该干预措施将比标准护理更具成本效益。该干预措施可以显著减少意外怀孕和流产，并改善母婴健康。我们的 PPFP 实施模式旨在具有可复制性，并可扩展到该地区其他同样对 PPFP 有高度未满足需求的国家。
ClinicalTrials.gov NCT05056545。注册于 2022 年 3 月 31 日。
