Family PlanningNCT05056545

Postpartum Family Planning Program in Rwanda

A study testing C4 Intervention in people with Family Planning, run by Emory University at 1 site in Rwanda.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Family Planning
What is being tested?: C4 Intervention
Type of treatment: Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38,220 participants
Where: 1 siteRwanda
Study dates: 1 Aug 2022to Mar 2027
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Prisoners

Trial locations and contacts

1 site in 1 country.

Rwanda1 site

Project San Francisco, Kigali
Kigali, Kigali Province

Other trials in Rwanda

About this study

Official title: Implementation and Evaluation of a Large-scale 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.

Read the 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.

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.

Conditions: Family Planning
Being tested: C4 Intervention
Keywords: Postpartum, Intrauterine Device, Long-acting reversible contraception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

C4 InterventionBehavioural
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.

Study groups in NCT05056545
Study group	Role	What they receive
PPFP Intervention	Experimental	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. Receives: Behavioral: C4 Intervention
Standard of Care	No 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before discharge after delivery (up to 2 days after delivery)

Secondary outcomes (2)

Cost-effectiveness/Cost-utility: Couple Years Protection (CYP)
Cost, in US dollars adjusted for the year of data analysis per CYP
Measured: 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
Measured: Years 2 and 4 of the project period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 2022Mar 2027

First posted24 Sep 2021
Study start1 Aug 2022
Primary completion30 Sep 2024
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Family PlanningStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 38,220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05056545
Sponsor's protocol ID: STUDY00002354
Other IDs: R01HD101600, 2023P006031
Status last verified: Aug 2026
First submitted: 14 Sep 2021
Last updated: 23 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification

Publications

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.
PubMed 35459259

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation and Evaluation of a Large-scale Postpartum Family Planning Program in Rwanda
ClinicalTrials.gov ID: NCT05056545
Acronym / sponsor ID: STUDY00002354
Conditions: Family Planning
Keywords: Postpartum, Intrauterine Device, Long-acting reversible contraception
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 38,220 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 1 Aug 2022 (actual)
Primary completion: 30 Sep 2024 (actual)
Study completion: Mar 2027 (estimated)
First posted: 24 Sep 2021 (actual)
Results: Posted 23 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
PPFP Intervention	Experimental	Behavioral: C4 InterventionThe 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.
Standard of Care	No 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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

Prisoners

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
C4 InterventionC4 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.	Behavioural	PPFP Intervention

Primary outcome

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.
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
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
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.
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.
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.
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.
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.
Number of PP Implant Insertions
Time frame: Up to postpartum week 14
The number of PP Implants provided to postpartum women after C4 counseling.
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.

2 secondary outcomes

Cost-effectiveness/Cost-utility: Couple Years Protection (CYP)
Time frame: Years 2 and 4 of the project period
Cost-effectiveness/Cost-utility: Cost Per Quality Adjusted Life Years (QALY)
Time frame: Years 2 and 4 of the project period

Results and safety

Results posted to the registry on 23 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cluster 1	6,954	6,954
Cluster 2	5,855	5,855
Cluster 3	3,958	3,958
Cluster 4	2,461	2,461
Pilot/Training Facilities	18,992	18,992

Primary outcome: Numbers of Clinic Directors Engaged

Time frame: Through study completion, an average of 2 years. Number. Unit: clinic directors

Measure	Cluster 1 n = 2	Cluster 2 n = 2	Cluster 3 n = 3	Cluster 4 n = 3	Pilot/Training Facilities n = 4
Value	2	2	3	3	4

Population analysed: This outcome refers to the clinic directors of facilities in each cluster (one clinic director per facility). Clinic directors were not considered enrolled in the study but were assessed for this measure.

Primary outcome: Number of Nurses Trained to Promote PPFP

Time frame: After completion of a 2-day training session. Number. Unit: Nurses

Measure	Cluster 1 n = 60	Cluster 2 n = 70	Cluster 3 n = 54	Cluster 4 n = 20	Pilot/Training Facilities n = 89
Value	60	70	54	20	89

Population analysed: This outcome refers to the nurses who complete PPFP promotion training per cluster of facilities. Nurses were not considered enrolled in the study but were assessed for this measure.

Primary outcome: Number of CHWs Trained to Promote PPFP

Time frame: After completion of a 2-day training session. Number. Unit: CHWs

Measure	Cluster 1 n = 11	Cluster 2 n = 10	Cluster 3 n = 30	Cluster 4 n = 23	Pilot/Training Facilities n = 22
Value	11	10	30	23	22

Population analysed: This outcome refers to the community health workers (CHWs) who completed the PPFP promotion training per cluster of facilities. CHWs were not considered enrolled in the study but were assessed for this measure.

Primary outcome: Number of Providers Trained to Provide PPFP

Time frame: After completion of a 2-day training session. Number. Unit: providers

Measure	Cluster 1 n = 20	Cluster 2 n = 21	Cluster 3 n = 15	Cluster 4 n = 16	Pilot/Training Facilities n = 41
Value	20	21	15	16	41

Population analysed: This outcome looks at the providers trained to provide PPFP per cluster of facilities. Providers were not considered enrolled in the study but were assessed for this measure.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through the end of study follow-up, up to post-partum week 14 (total up to 54 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PPFP Intervention	2 of 16,254 (0%)	25 of 16,254 (0.2%)	1 of 16,254

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35459259Wall 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.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristin Wall, PhD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing C4 Intervention in people with Family Planning, run by Emory University at 1 site in Rwanda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numbers of Clinic Directors Engaged (time frame: Through study completion, an average of 2 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05056545, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.