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NCT Number: NCT05098015

Randomized Controlled Trial of Game Changers

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.

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Key information

Conditions

HIV Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Infectious Diseases Institute

Kampala, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. HIV Testing

    Time frame: Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18)

    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.

  2. Condom Use

    Time frame: Reports of always using condoms in the past 6 months, as assessed at each follow-up assessment (Month 6, Month 12, Month 18)

    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.

Secondary outcomes

  1. Internalized HIV Stigma

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

    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

  2. HIV Prevention Advocacy

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

    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

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • Indiana University
  • Infectious Diseases Institute, Uganda
  • Makerere University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2021
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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