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Active, not recruiting

NCT Number: NCT05056545

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Project San Francisco, Kigali

Kigali, Rwanda

About this study

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.

In this trial, the study team used 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, the study team evaluated 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. The study team expected that this project would deliver PPFP counseling to over 21,000 women/couples during the project period. They also evaluated the PPFP intervention effectiveness and implementation processes using RE-AIM (Aim 2). The team hypothesized that the PPFP intervention would 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 was expected that PPFP client satisfaction resulted high and side-effects, rare. The independent effectiveness of each demand creation strategy on LARC uptake was estimated. Assessment of measures of PPFP intervention adoption, implementation, and maintenance at the patient-, provider- and stakeholder-level to assess PPFP intervention sustainability was 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C4 Intervention

Behavioral

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.

Primary outcomes

  1. Numbers of Clinic Directors Engaged

    Time frame: Through study completion, an average of 2 years

    Number of clinic directors engaged to support implementation of the PPFP intervention. Clinic directors were engaged at the beginning and end of intervention activities in each cluster and as needed, throughout intervention implementation to facilitate study activities until study completion.

  2. Number of Nurses Trained to Promote PPFP

    Time frame: After completion of a 2-day training session

    The number of nurses who complete PPFP intervention session to promote PPFP use

  3. Number of CHWs Trained to Promote PPFP

    Time frame: After completion of a 2-day training session

    The number of community health workers (CHWs) who complete C4 training session to promote PPFP use

  4. Number of Providers Trained to Provide PPFP

    Time frame: After completion of a 2-day training session

    Nurses and midwives working in 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.

  5. Number of Providers Certified to Provide PPFP

    Time frame: After completion of a 2-day training session

    After completing the didactic training, providers will have the opportunity to become certified, by correctly inserting 5 PPIUDs and 5 PP implants under supervision.

  6. Number of Promotions to Pregnant or Postpartum Women/Couples

    Time frame: Beginning at the first antenatal care visit up to post-partum week 14 (up to 54 weeks)

    The number of one-on-one C4 counseling promotions received by pregnant or postpartum women/couples.

  7. Number of PPIUD Insertions

    Time frame: Up to postpartum week 14

    The number of PPIUDs provided to postpartum women after C4 counseling. PPIUDs may refer to hormonal or copper IUDs.

  8. Percentage of Deliveries Followed by PPIUD Insertions

    Time frame: Before discharge after delivery (up to 2 days after delivery)

    This outcome reports the percentage of deliveries followed by a PPIUD insertion in postpartum women in the Standard of Care (SOC) and C4 Intervention time periods.

  9. Number of PP Implant Insertions

    Time frame: Up to postpartum week 14

    The number of PP Implants provided to postpartum women after C4 counseling.

  10. Percentage of Deliveries Followed by PP Implant Insertion

    Time frame: Before discharge after delivery (up to 2 days after delivery)

    This outcome reports the percentage of deliveries followed by a PP Implant insertion in the Standard of Care and C4 Intervention time periods.

Secondary outcomes

  1. Cost-effectiveness/Cost-utility: Couple Years Protection (CYP)

    Time frame: Years 2 and 4 of the project period

    Cost, in US dollars adjusted for the year of data analysis per CYP

  2. Cost-effectiveness/Cost-utility: Cost Per Quality Adjusted Life Years (QALY)

    Time frame: Years 2 and 4 of the project period

    Cost, in US dollars adjusted for the year of data analysis of cost per QALY saved

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Sep 24, 2021
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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