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

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

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

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.

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