Postpartum Family Planning Program in Rwanda

Emory University

Status: Enrolling

Conditions: Family Planning

Treatments: Behavioral: C4 Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05056545

STUDY00002354

R01HD101600 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26,215 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26,215 participants in 2 patient groups

PPFP Intervention

Experimental group

Description:

The study team will train government clinic staff in ANC, L\&D, IV, or postpartum services to promote and provide the PPFP intervention at the selected facilities. Community Health Workers (CHW) and 'Happy Clients' will be trained as PPFP promotional agents. Video-based PPFP promotions will be shown at the intervention facilities. If interested in PPFP, women will be referred to the facility by their CHW.

Treatment:

Behavioral: C4 Intervention

Standard of Care

No Intervention group

Description:

Currently, no systematic PPFP training, promotional, or service delivery activities are regularly taking place at the selected facilities. The team will compare the intervention with historical records from the facilities applying intervention and compare