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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date May 2024
Source RAND
Contact Glenn Wagner
Phone 3234284376
Email gwagner@rand.org
Is FDA regulated No
Health authority
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 192
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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Game Changers for Family Planning
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.

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
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