GC-FP: Pilot Controlled Trial of Game Changers for Family Planning Peer Advocacy Program

Sponsor

RAND (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06048328

Collaborator

Makerere University (Other)

160

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Family Planning	Behavioral: Game Changers for Family Planning	Phase 1/Phase 2

Detailed Description

we 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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel randomized controlled trial, with individual randomization to receive the intervention or wait-list controlparallel randomized controlled trial, with individual randomization to receive the intervention or wait-list control

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 2, 2025

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention peer-led, multi-session advocacy training group intervention	Behavioral: Game Changers for Family Planning Game Changers for Family Planning (GC-FP) intervention. We expect the intervention to 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.
No Intervention: Wait-list control Usual care/no intervention

Arm

Intervention/Treatment

Experimental: Intervention

peer-led, multi-session advocacy training group intervention

Behavioral: Game Changers for Family Planning

Game Changers for Family Planning (GC-FP) intervention. We expect the intervention to 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.

No Intervention: Wait-list control

Usual care/no intervention

Outcome Measures

Primary Outcome Measures

Rate of use of modern contraceptives (social network participants) [6 months]
Proportion of participants who use a modern contraceptive, abstracted from medical chart

Secondary Outcome Measures

Mean level of engagement in family planning advocacy (index participants) [6 months]
Mean item score on self-report scale measuring engagement in family planning advocacy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

RAND
Makerere University

Investigators

Principal Investigator: Glenn Wagner, RAND

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

RAND

ClinicalTrials.gov Identifier:

NCT06048328

Other Study ID Numbers:

2024-GC-FP

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by RAND

contraception

Study Results

No Results Posted as of Sep 21, 2023