Randomized Controlled Trial of Game Changers

Controlled Trial of Game Changers: A Group Intervention to Train HIV Clients to be Change Agents for HIV Prevention in Uganda

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.

Study Overview

• Status: Completed
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: Game Changers

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 Type: Interventional
• Enrollment (Actual): 809
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Infectious Diseases Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention- index; 8-session group intervention to train index participants to engage in HIV prevention advocacy.	Behavioral: Game Changers; 8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy.
No Intervention: Usual care control- index; Participants will receive HIV usual care, and no added intervention.
No Intervention: Intervention- alter; Enrolled alter participants recruited by index participants assigned to the intervention comprise this arm
No Intervention: Usual care control- alter; ALter participants recruited by index participants assigned to the usual care control group comprise this arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Testing	For each index participant (PLWH), data is examined from their enrolled alters and the percent of these alters who self-reported HIV testing behavior (yes/no) at each follow-up assessment is calculated, followed by the average percent across all follow-up assessments. Therefore, data from all three follow-up timepoints (months 6, 12 18) were pooled and an average calculated across the timepoints.	Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18)
Condom Use	For each index participant (PLWH), data is examined from their enrolled alters and the percent of these alters who self-reported always using condoms use during intercourse at each follow-up assessment is calculated, followed by the average percentage across all follow-up assessments. Therefore, data from all three follow-up timepoints (months 6, 12 18) were pooled and an average calculated across the timepoints.	Reports of always using condoms in the past 6 months, as assessed at each follow-up assessment (Month 6, Month 12, Month 18)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internalized HIV Stigma	This outcome is based solely on data from the index participants. Self-reported internalized HIV stigma (on 1-5 scale, with higher scores represented greater stigma); scale score is averaged across all follow-up assessments	Reported at each follow-up assessment (Months 6, 12, 18)
HIV Prevention Advocacy	This outcome is based solely on data from the index participants. Self-reported prevention advocacy (on 1-5 scale, with higher scores representing greater engagement in advocacy); scores are averaged across all follow-up assessments	Past 6 months as assessed at each follow-up (Months 6, 12, 18)

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: Indiana University; Makerere University; Infectious Diseases Institute, Uganda
• Investigators: Principal Investigator: Glenn Wagner, RAND

Publications and helpful links

General Publications

• Wagner GJ, Bogart LM, Green HD, Storholm ED, Klein DJ, McBain RK, Serunkuuma R, Mubiru K, Matovu JKB, Okoboi S. Social network-based group intervention to promote HIV prevention in Uganda: study protocol for a cluster randomized controlled trial of Game Changers. Trials. 2022 Mar 28;23(1):233. doi: 10.1186/s13063-022-06186-z.
• Bogart LM, Matovu JKB, Green HD Jr, Ninsiima S, Klein DJ, Gwokyalya V, Serunkuuma R, Ghosh-Dastidar B, Mubiru K, Nabukeera M, Malika N, Okoboi S, Wagner GJ. Randomized Controlled Trial of Game Changers, a Social Network Intervention for HIV Prevention in Uganda. AIDS Behav. 2025 Nov 11:10.1007/s10461-025-04907-4. doi: 10.1007/s10461-025-04907-4. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Actual): October 25, 2024
• Study Completion (Actual): October 25, 2024

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2021-N0155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified dataset will be made available upon review of requests from outside researchers
• IPD Sharing Time Frame: Following publication of primary results of the study (approximately August 2026).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No