Postpartum Family Planning Program in Rwanda

Family Planning Clinical Trial

Official title:

Implementation and Evaluation of a Large-scale Postpartum Family Planning Program in Rwanda

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056545
• Other study ID #: STUDY00002354
• Secondary ID: R01HD101600
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: Emory University
• Contact: Kristin Wall, PhD
• Phone: 404-727-9088
• Email: kmwall[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Family Planning

Intervention

Behavioral:
• C4 Intervention
C4 Intervention, is an innovative form of Post Partum Family Planning (PPFP). PPFP methods include: the copper intrauterine device, hormonal implant, tubal ligation, and (after 6 weeks post-partum in breastfeeding women) Depo-Provera and oral contraceptive pills. These are provided as current, standard of care in Rwanda, are procured by the government, and administered by trained nurses and doctors. The C4 training will occur at the 4 pilot facilities. Training will include a 2-day didactic session covering PPFP provision, follow-up, use of the C4 counseling flipchart; mock counseling sessions; and PPIUD and PP implant insertion and removal trainings. The study team will train government clinic staff in family planning, ANC, L&D, and IV to promote C4 at the selected facilities. 'Happy Clients' will be recruited from women who received promotions and selected PPFP to join a clinic-based PPFP promotions team. Women interested in PPFP will be referred to the facility by their CHW.

Locations

Country	Name	City	State
Rwanda	Project San Francisco, Kigali	Kigali	Kigali Province

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Rwanda, 

Outcome

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