Randomized Controlled Trial of Game Changers

NCT05098015 | Completed Results DMC

• 1 other identifier: 2021-N0155
• Study Type: interventional
• Target: 809
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Internalized HIV Stigma

  Reported at each follow-up assessment (Months 6, 12, 18)

• HIV Prevention Advocacy

  Past 6 months as assessed at each follow-up (Months 6, 12, 18)

Study Arms (4)

Intervention- index

EXPERIMENTAL

8-session group intervention to train index participants to engage in HIV prevention advocacy.

Behavioral: Game Changers

Usual care control- index

NO INTERVENTION

Participants will receive HIV usual care, and no added intervention.

Intervention- alter

NO INTERVENTION

Enrolled alter participants recruited by index participants assigned to the intervention comprise this arm

Usual care control- alter

NO INTERVENTION

ALter participants recruited by index participants assigned to the usual care control group comprise this arm

Interventions

Game Changers BEHAVIORAL

8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy.

Intervention- index

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RAND: lead
• Infectious Diseases Institute, Uganda: collaborator
• Makerere University: collaborator
• Indiana University: collaborator

Study Sites (1)

Infectious Diseases Institute

Kampala, Uganda

Location

Related Publications (2)

• 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.

  PMID: 41214256 DERIVED

• 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.

  PMID: 35346329 DERIVED

Results Point of Contact

• Title: Glenn Wagner
• Organization: RAND

gwagner@rand.org

310-393-0411

Study Officials

• Glenn Wagner

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment interviewer will be blinded to study arm allocation of the participants at baseline only.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individual randomization of index participants (and their recruited alter participants) to one of two parallel groups, the intervention or usual care (no intervention) control group. Therefore there are 4 study groups: index intervention, alter intervention, index control and alter control

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 28, 2021
• Study Start: January 24, 2022
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following publication of primary results of the study (approximately August 2026).

Locations

UG (1)