An interventional study of C4 Intervention in Family Planning, sponsored by Emory University. Active, not recruiting at 1 site in Rwanda. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Emory University · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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.
Behavioral: C4 Intervention
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
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.
Numbers of Clinic Directors Engaged
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.
Time frame: Through study completion, an average of 2 years
Number of Nurses Trained to Promote PPFP
The number of nurses who complete PPFP intervention session to promote PPFP use
Time frame: After completion of a 2-day training session
Number of CHWs Trained to Promote PPFP
The number of community health workers (CHWs) who complete C4 training session to promote PPFP use
Time frame: After completion of a 2-day training session
Number of Providers Trained to Provide PPFP
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.
Time frame: After completion of a 2-day training session
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.
Time frame: After completion of a 2-day training session
Number of Promotions to Pregnant or Postpartum Women/Couples
The number of one-on-one C4 counseling promotions received by pregnant or postpartum women/couples.
Time frame: Beginning at the first antenatal care visit up to post-partum week 14 (up to 54 weeks)
Number of PPIUD Insertions
The number of PPIUDs provided to postpartum women after C4 counseling. PPIUDs may refer to hormonal or copper IUDs.
Time frame: Up to postpartum week 14
Percentage of Deliveries Followed by PPIUD Insertions
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.
Time frame: Before discharge after delivery (up to 2 days after delivery)
Number of PP Implant Insertions
The number of PP Implants provided to postpartum women after C4 counseling.
Time frame: Up to postpartum week 14
Percentage of Deliveries Followed by PP Implant Insertion
This outcome reports the percentage of deliveries followed by a PP Implant insertion in the Standard of Care and C4 Intervention time periods.
Time frame: Before discharge after delivery (up to 2 days after delivery)
Cost-effectiveness/Cost-utility: Couple Years Protection (CYP)
Cost, in US dollars adjusted for the year of data analysis per CYP
Time frame: Years 2 and 4 of the project period
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
Time frame: Years 2 and 4 of the project period
The study was conducted under a waiver of informed consent. Participants include women receiving services during the intervention period; these are counted in Enrollment, Baseline Characteristics, and Participant Flow. Aggregate facility-level data from pre-intervention and intervention periods are not individual participants and are not included as enrolled.
| Milestone | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities |
|---|---|---|---|---|---|
| Started | 6954 | 5855 | 3958 | 2461 | 18992 |
| Completed | 6954 | 5855 | 3958 | 2461 | 18992 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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.
| clinic directors | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities |
|---|---|---|---|---|---|
| Numbers of Clinic Directors Engaged | 2 | 2 | 3 | 3 | 4 |
The number of nurses who complete PPFP intervention session to promote PPFP use
| Nurses | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities |
|---|---|---|---|---|---|
| Number of Nurses Trained to Promote PPFP | 60 | 70 | 54 | 20 | 89 |
The number of community health workers (CHWs) who complete C4 training session to promote PPFP use
| CHWs | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities |
|---|---|---|---|---|---|
| Number of CHWs Trained to Promote PPFP | 11 | 10 | 30 | 23 | 22 |
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.
| providers | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities |
|---|---|---|---|---|---|
| Number of Providers Trained to Provide PPFP | 20 | 21 | 15 | 16 | 41 |
After completing the didactic training, providers will have the opportunity to become certified, by correctly inserting 5 PPIUDs and 5 PP implants under supervision.
| providers | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities |
|---|---|---|---|---|---|
| Number of Providers Certified to Provide PPFP | 15 | 17 | 11 | 4 | 34 |
The number of one-on-one C4 counseling promotions received by pregnant or postpartum women/couples.
| promotions | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities |
|---|---|---|---|---|---|
| Number of Promotions to Pregnant or Postpartum Women/Couples | 7695 | 7010 | 4798 | 2629 | 20245 |
The number of PPIUDs provided to postpartum women after C4 counseling. PPIUDs may refer to hormonal or copper IUDs.
| PPIUD insertions | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities |
|---|---|---|---|---|---|
| Number of PPIUD Insertions | 943 | 572 | 563 | 151 | 3074 |
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.
| percentage of deliveries | PPFP Intervention | Standard of Care | Pilot/Training Facilities: PPFP Intervention | Pilot/Training Facilities: Standard of Care |
|---|---|---|---|---|
| Percentage of Deliveries Followed by PPIUD Insertions | 9 | 1 | 11 | 3 |
The number of PP Implants provided to postpartum women after C4 counseling.
| PP Implant insertions | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities |
|---|---|---|---|---|---|
| Number of PP Implant Insertions | 2660 | 2066 | 789 | 681 | 4775 |
Cost, in US dollars adjusted for the year of data analysis per CYP
Results for this outcome have not been posted.
Cost, in US dollars adjusted for the year of data analysis of cost per QALY saved
Results for this outcome have not been posted.
This outcome reports the percentage of deliveries followed by a PP Implant insertion in the Standard of Care and C4 Intervention time periods.
| percentage of deliveries | PPFP Intervention | Standard of Care | Pilot/Training Facilities: PPFP Intervention | Pilot/Training Facilities: Standard of Care |
|---|---|---|---|---|
| Percentage of Deliveries Followed by PP Implant Insertion | 38 | 31 | 17 | 11 |
Collected over Through the end of study follow-up, up to post-partum week 14 (total up to 54 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PPFP Intervention | 1/16,254 (0%) | 2/16,254 (0%) | 25/16,254 (0.2%) |
| Event | PPFP Intervention |
|---|---|
| Ascites post Copper PPIUD insertionGastrointestinal disorders | 1/5283 |
| Sudden death post Copper PPIUD insertionInjury, poisoning and procedural complications | 1/5283 |
| Event | PPFP Intervention |
|---|---|
| Back pain post copper PPIUD insertionMusculoskeletal and connective tissue disorders | 3/5283 |
| Infection post copper IUD insertionInfections and infestations | 2/5283 |
| Vaginal infection post copper PPIUD insertionInfections and infestations | 2/5283 |
| Vertigo post copper PPIUD insertionEar and labyrinth disorders | 2/5283 |
| Insertion site infection post PP ImplantInfections and infestations | 4/10971 |
| Urinary tract infection post copper PPIUD insertionRenal and urinary disorders | 1/5283 |
| Influenza post copper PPIUD insertionInfections and infestations | 1/5283 |
| Malaria post copper PPIUD insertionInfections and infestations | 1/5283 |
| Gonorrhea post copper PPIUD insertionReproductive system and breast disorders | 1/5283 |
| STI post copper PPIUD insertion (Gonorrhea/Chlamydia)Reproductive system and breast disorders | 1/5283 |
Participants refer to women receiving services at study facilities during the intervention period. Enrollment is defined as inclusion in the analytic dataset under a waiver of informed consent. Clinic staff and promoters were not participants.
| Age, Continuous(years) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities | Total |
|---|---|---|---|---|---|---|
| Mean | 28.4 ± 6.5 | 28.1 ± 6.4 | 28.1 ± 6.3 | 28.1 ± 6.4 | 28.5 ± 6.2 | 28.3 ± 6.3 |
| Sex: Female, Male(Participants) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities | Total |
|---|---|---|---|---|---|---|
| Female | 6954 | 5855 | 3958 | 2461 | 18992 | 38220 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 6954 | 5855 | 3958 | 2461 | 18992 | 38220 |
| White | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Pilot/Training Facilities | Total |
|---|---|---|---|---|---|---|
| Rwanda | 6954 | 5855 | 3958 | 2461 | 18992 | 38220 |
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Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification
Supporting information: Study protocol
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Emory University