Game Changers for Family Planning Peer Advocacy Program

Family Planning Clinical Trial

— GC-FP  

Official title:

Pilot of a Peer Advocacy Training Intervention to Reduce Unmet Need for Contraception in Uganda

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06048328
• Other study ID #: 2024-GC-FP
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2, 2025
• Est. completion date: November 1, 2025

Study information

• Verified date: October 2023
• Source: RAND
• Contact: Glenn Wagner
• Phone: 3234284376
• Email: gwagner[@]rand.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Family Planning

Intervention

Behavioral:
• Game Changers for Family Planning
Game Changers for Family Planning (GC-FP) intervention. The intervention will consist of 7 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
RAND	Makerere University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of use of modern contraceptives (social network participants)	Proportion of participants who use a modern contraceptive, abstracted from medical chart	6 months
Secondary	Mean level of engagement in family planning advocacy (index participants)	Mean item score on self-report scale measuring engagement in family planning advocacy	6 months