Clinical trial NCT05056545: Postpartum Family Planning Program in Rwanda
Official title: Implementation and Evaluation of a Large-scale Postpartum Family Planning Program in Rwanda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Family Planning
Keywords: Postpartum
Intrauterine Device
Long-acting reversible contraception
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-09-24
Enrollment: 26215
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This step-wedge clinical trial will train all nurse/midwives working in antenatal care (ANC), labor and delivery (L\&D), infant vaccination (IV), or postpartum services at one of the study facilities in PPFP promotions or provision. The study team will train 'Happy Clients' (postpartum women who received promotions and selected a PPFP method) and community health workers affiliated with the intervention facilities as PPFP promotional agents. Women eligible for PPFP services in this study will be at any stage of pregnancy or up to 14 weeks postpartum, and receiving ANC, L\&D, IV, or postpartum services at one of the intervention facilities.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: In 2017-2018, the study team worked closely with the Rwanda Ministry of Health (MOH) to develop and pilot test a theory-based, multi-level intervention targeting postpartum family planning (PPFP) supply and demand in 4 government health facilities in Kigali, the capital. This innovative PPFP intervention was informed by clients, clinic providers, champions, and Community Health Workers. Long-acting reversible contraceptives (LARC), the intrauterine device (PPIUD) and implant, are fundamental to PPFP programs. LARCs are highly effective and are the only reversible methods that may be safely used in early postpartum period by breastfeeding women. During the pilot, LARC uptake among postpartum women increased significantly (172% for PP implant, 2,687% for PPIUD), PPFP feasibility and acceptability were high among providers and clients, and side-effects were rare.

The study team now proposes to use an implementation science framework to evaluate the effectiveness of different PPFP demand creation strategies and test the hypothesis that our PPFP intervention is adaptable to large-scale implementation, cost-effective, and sustainable. In a Type 2 effectiveness-implementation hybrid study, we will evaluate facility organizational readiness prior to implementing the PPFP intervention in a clinic randomized trial in 10 high-volume health facilities in Kigali, Rwanda (Aim 1). Adaptability and sustainability within government facilities is a critical aspect of the proposal, and the MOH and other local stakeholders will be engaged from the outset. It is expected that this project will deliver PPFP counseling to over 21,000 women/couples during the project period. They will then evaluate the PPFP intervention effectiveness and implementation processes using RE-AIM (Aim 2). The team hypothesizes that the PPFP intervention will significantly increase the number of stakeholders engaged, PPFP providers and promoters, couples/clients receiving information about PPFP (reach), and LARC uptake (effectiveness) comparing intervention versus standard of care. It is expected that PPFP client satisfaction will be high and side-effects will be rare. The independent effectiveness of each demand creation strategy on LARC uptake will be estimated. Assessment of measures of PPFP intervention adoption, implementation, and maintenance at the patient-, provider- and stakeholder-level to assess PPFP intervention sustainability will be completed by the study team. Finally, this project will evaluate PPFP intervention cost-effectiveness and develop a national costed implementation plan to guide Rwandan MOH decision-making for nationwide roll-out of PPFP services (Aim 3). This trial hypothesizes that the PPFP intervention will be cost-saving relative to standard of care.

This intervention represents an important contribution to the Rwanda Family Planning 2020 goals and the MOH are enthusiastic to see our successful pilot efforts expanded to a larger number of facilities for greater and sustained impact. The new PPFP implementation model is designed to be replicable and expandable to other countries in the region which similarly have high unmet need for PPFP.

Eligibility criteria: 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

Primary outcomes:
measure: Numbers of clinic directors engaged
timeFrame: Through study completion, an average of 3 years
measure: Number of Nurses trained to promote PPFP
timeFrame: After completion of a 2-day training
measure: Number of CHWs trained to promote PPFP
timeFrame: After completion of a 2-day training session
measure: Number of providers trained to provide PPFP
timeFrame: After completion of a 2-day training session
measure: Number of providers certified to provide PPFP
timeFrame: After completion of a 2-day training session
measure: Number of promotions to pregnant or postpartum women/couples
timeFrame: Beginning at the first antenatal care visit up to post-partum week 14 (up to 54 weeks)
measure: Number of PPIUD insertions
timeFrame: Up to postpartum week 14
measure: Number of PP implant insertions
timeFrame: Up to postpartum week 14
Secondary outcomes:
measure: Cost-effectiveness/cost-utility: Couple Years Protection (CYP)
timeFrame: Years 2 and 4 of the project period
measure: Cost-effectiveness/cost-utility: Cost per Quality Adjusted life years (QALY)
timeFrame: Years 2 and 4 of the project period
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Project San Francisco, Kigali
state: Kigali Province
Study officials:
affiliation: Emory University
name: Kristin Wall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wall KM, Ingabire R, Mazzei A, Umuhoza C, Parker R, Tichacek A, Nizam A, Sales JM, Haddad LB, Corso P, Allen S, Nyombayire J, Karita E. Implementation and evaluation of a large-scale postpartum family planning program in Rwanda: study protocol for a clinic-randomized controlled trial. Trials. 2022 Apr 22;23(1):337. doi: 10.1186/s13063-022-06261-5.