Randomized Controlled Trial of Game Changers

Not Applicable

Completed

• Conditions: HIV Prevention
• Interventions: Behavioral: Game Changers

• Registration Number: NCT05098015
• Lead Sponsor: RAND

Brief Summary

The study is a randomized controlled trial (RCT) of Game Changers, an 8-session peer-led group intervention that aims to empower and mobilize people living with HIV (PLWH) to be agents for HIV prevention in their social networks.

Detailed Description

This RCT of Game Changers, a peer-led group intervention for persons living with HIV (PLWH) in Uganda, will test intervention effects on the primary outcomes of reduced condomless sex, increased HIV testing, and decreased enacted HIV stigma among social network members. We will recruit 210 PLWH, randomizing 105 to the intervention and 105 to an attention control. Each PLWH will be asked to recruit up to 4 social network members to complete assessments (736 total, 368/arm). All participants will complete surveys at baseline and 6-, 12-, and 18-months post-baseline.

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-28
• Study Start: 2022-01-24
• Primary Completion: 2024-10-25
• Study Completion: 2024-10-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 885

Inclusion Criteria

• age 18 years and older
• HIV-positive
• in HIV care at The Infectious DIseases Institute for at least one year

Exclusion Criteria

• Participated in the prior pilot study of the intervention.
• Has significant cognitive impairment
• Health status is not sufficiently stable to reliably complete 18 month study.
• Does not speak Luganda fluently (index participant); English or Luganda fluently (social network participant)
• spouse/partner or household member are enrolled as index participant in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Game Changers	8-session group intervention to train participants to engage in HIV prevention advocacy.

Primary Outcome Measures

Name	Time	Method
Condom use	Past 6 months	Self-reported consistent condom use during intercourse by social network members (always vs sometime/never)
HIV testing	Past 6 months	Self-reported HIV testing behavior by social network members (yes/no)

Secondary Outcome Measures

Name	Time	Method
Internalized HIV stigma	Past 6 months	Self-reported internalized HIV stigma among people living with HIV (on 1-5 scale)
HIV prevention advocacy	Past 6 months	Self-reported prevention advocacy among people living with HIV (on 1-5 scale)

Trial Locations

Locations (1)

Infectious Diseases Institute; 🇺🇬 Kampala, Uganda