- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06048328
Game Changers for Family Planning Peer Advocacy Program (GC-FP)
December 23, 2025 updated by: RAND
Pilot of a Peer Advocacy Training Intervention to Reduce Unmet Need for Contraception in Uganda
This study will adapt the Game Changers peer advocacy training model for family planning context and pilot test the feasibility, acceptability and preliminary efficacy of the intervention to empower female contraception users to advocate for contraception use among women in their social networks who have unmet need for contraception.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The investigators will conduct a pilot RCT of Game Changers for Family Planning (GC-FP) with 40 female modern contraceptive (MC) users (index participants) at one rural public clinic, with 20 randomly assigned to receive the intervention (in 2 groups of 10) and 20 to the wait-list control; enrollment and randomization will be stratified by age and relationship status.
Each index will recruit up to 3 social network members (alters) with unmet need for MC (max.
total=120).
Data will be collected at baseline and month 6 from all participants; primary outcome is alter MC use at month 6.
Study Type
Interventional
Enrollment (Estimated)
192
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Glenn Wagner
- Phone Number: 3234284376
- Email: gwagner@rand.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Index participants:
Inclusion Criteria:
- MC user for past year
Social network member participant:
Inclusion Criteria:
- Not using MC, but reports trying to prevent pregnancy
- Know about the MC use of their referring index participant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
peer-led, multi-session advocacy training group intervention
|
Game Changers for Family Planning (GC-FP) intervention.
The intervention will consist of 6 group sessions.
The sessions will focus on stigma reduction, disclosure decision making, knowledge, and building skills for advocacy.
The 2-hour, weekly sessions will be facilitated by 2 trained peers who are MC users, and conducted in Luganda using a structured manual, and group format to facilitate: sharing of experiences to build support, modeling and motivation; group problem solving and role playing to build skills and self-efficacy; and homework between sessions to practice skills and generate experiences to be processed in the group.
|
|
No Intervention: Wait-list control
Usual care/no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of use of modern contraceptives (social network participants)
Time Frame: 6 months
|
Proportion of participants who use a modern contraceptive, abstracted from medical chart
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean level of engagement in family planning advocacy (index participants)
Time Frame: 6 months
|
Mean item score on self-report scale measuring engagement in family planning advocacy
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Glenn Wagner, RAND
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 15, 2027
Primary Completion (Estimated)
November 1, 2030
Study Completion (Estimated)
July 1, 2031
Study Registration Dates
First Submitted
September 8, 2023
First Submitted That Met QC Criteria
September 15, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
December 31, 2025
Last Update Submitted That Met QC Criteria
December 23, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-GC-FP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The investigators will create public use data files that include a deidentified quantitative dataset that includes longitudinal participant-level survey scales and social network assessment data (related to the primary research questions around family planning, and moderators and mediators of the associations between the intervention and contraception use); and an excel spreadsheet with the qualitative codebook with representative quotes on key themes by subgroup, linked to ID.
Only predictors and outcomes data (e.g., contraception use) will be shared; additional variables (e.g., socio-demographic characteristics) will not be included to prevent the potential and unintentional de-identification of participants.
IPD Sharing Time Frame
one year after completion of study, for 12 months
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Family Planning
-
Inonu UniversityThe Scientific and Technological Research Council of TurkeyCompletedFamily PlanningTurkey
-
Boston UniversityUnited States Agency for International Development (USAID); Pharmaceutical...Completed
-
Addis Ababa UniversityUnknown
-
University of California, San FranciscoPopulation Services InternationalCompleted
-
Assiut UniversityCompleted
-
Instituto Materno Infantil Prof. Fernando FigueiraCompleted
-
Jacaranda HealthHarvard School of Public Health (HSPH); Jhpiego; IPSOSRecruitingPostpartum Family PlanningKenya
-
Saint-Joseph UniversityRecruitingFamily Planning ServicesLebanon
-
Assiut UniversityNot yet recruiting
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
Clinical Trials on Game Changers for Family Planning
-
RANDMakerere University; Rays of Hope Hospice Jinja; African Palliative Care Association and other collaboratorsCompleted
-
RANDIndiana University; Makerere University; Infectious Diseases Institute, UgandaCompleted
-
RANDInfectious Diseases Institute, UgandaCompleted
-
Adiyaman UniversityNot yet recruitingContraceptionTurkey (Türkiye)
-
Johns Hopkins Bloomberg School of Public HealthBill and Melinda Gates Foundation; Kwame Nkrumah University of Science and...CompletedContraceptionGhana, United States
-
University of PennsylvaniaNational Institute of Allergy and Infectious Diseases (NIAID); University of...Completed
-
Maureen LyonNational Institute of Nursing Research (NINR); St. Jude Children's Research... and other collaboratorsCompleted
-
Hawassa UniversityEngenderHealthCompleted
-
FHI 360Ministry of Health, RwandaCompleted
-
University of UtahDepartment of Health and Human ServicesCompletedPregnancy | FertilityUnited States, Canada