HIV PreventionNCT05098015

Randomized Controlled Trial of Game Changers

A study testing Game Changers in people with HIV Prevention, run by RAND at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Prevention
What is being tested?: Game Changers
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 809 participants
Where: 1 siteUganda
Study dates: 24 Jan 2022to 25 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Uganda1 site

Infectious Diseases Institute
Kampala

Other trials in Uganda

About this study

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

Read the 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.

Conditions: HIV Prevention
Being tested: Game Changers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05098015
Study group	Role	What they receive
Intervention- index	Experimental	8-session group intervention to train index participants to engage in HIV prevention advocacy. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 202225 Oct 2024

First posted28 Oct 2021
Study start24 Jan 2022
Primary completion25 Oct 2024
Study completion25 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HIV PreventionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 809 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05098015
Sponsor's protocol ID: 2021-N0155
Status last verified: Dec 2025
First submitted: 18 Oct 2021
Last updated: 15 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A de-identified dataset will be made available upon review of requests from outside researchers

Publications

Wagner GJ, Bogart LM, Matovu JKB, Gwokyalya V, Green HD Jr, Ninsiima S, Klein DJ, Okoboi S. Mediators of the effects of an HIV prevention advocacy training intervention on prevention advocacy among persons living with HIV in Uganda. J Behav Med. 2026 Aug 31. doi: 10.1007/s10865-026-00704-z. Online ahead of print.
PubMed 42671691
Wagner GJ, Bogart LM, Okoboi S, Gwokyalya V, Green HD, Klein DJ, Ninsiima S, Matovu JKB. HIV Disclosure and Prevention Advocacy Partially Mediate Advocacy Training Intervention Effect on Reduced Internalized HIV Stigma. AIDS Behav. 2026 May 23:10.1007/s10461-026-05179-2. doi: 10.1007/s10461-026-05179-2. Online ahead of print.
PubMed 42176077
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. 2026 Apr;30(4):1007-1021. doi: 10.1007/s10461-025-04907-4. Epub 2025 Nov 11.
PubMed 41214256
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.
PubMed 35346329

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Prevention trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Controlled Trial of Game Changers: A Group Intervention to Train HIV Clients to be Change Agents for HIV Prevention in Uganda
ClinicalTrials.gov ID: NCT05098015
Acronym / sponsor ID: 2021-N0155
Conditions: HIV Prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 809 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Infectious Diseases Institute, Uganda, Makerere University, Indiana University
Study start: 24 Jan 2022 (actual)
Primary completion: 25 Oct 2024 (actual)
Study completion: 25 Oct 2024 (actual)
First posted: 28 Oct 2021 (actual)
Results: Posted 15 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: 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

Arm	Type	Receives
Intervention- index	Experimental	Behavioral: Game Changers8-session group intervention to train index participants to engage in HIV prevention advocacy.
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Game Changers8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy.	Behavioural	Intervention- index

Primary outcome

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.
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.

2 secondary outcomes

Internalized HIV Stigma
Time frame: Reported at each follow-up assessment (Months 6, 12, 18)
HIV Prevention Advocacy
Time frame: Past 6 months as assessed at each follow-up (Months 6, 12, 18)

Results and safety

Results posted to the registry on 15 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention- Index	105	103
Usual Care Control- Index	105	102
Intervention- Alter	324	318
Usual Care Control- Alter	275	270

Primary outcome: HIV Testing

Time frame: Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18). Mean (Standard Deviation). Unit: percentage of alters

Measure	Intervention- Index n = 91	Usual Care Control- Index n = 78
Value	71.60 (35.23)	71.61 (37.19)

Intervention- Index vs Usual Care Control- Index: Slope: 0.25, p = 0.95, Regression, Linear

Population analysed: The Participant Flow included data from all index (PLWH) and alter participants, while the outcome measures are based on index-level measures-- for each index participant, the measure reflects data reported by their enrolled alters. For this specific measure (HIV testing), index participants provided data for analysis if (a) at least one of their alters was not living with HIV at the time of the assessment; and (2) data was present in at least one of the follow-up assessments

Primary outcome: 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). Mean (Standard Deviation). Unit: percentage of alters

Measure	Intervention n = 92	Usual Care Control n = 88
Value	18.04 (29.60)	13.15 (27.06)

Intervention vs Usual Care Control: Slope: 4.38, p = 0.16, Regression, Linear

Population analysed: The Participant Flow included data from all index (PLWH) and alter participants, while the outcome measures are based on index-level measures-- for each index participant, the measure reflects data reported by their enrolled alters. Index participants were included in the analysis if (a) at least one of their alters reported engaging in sexual intercourse in the 6 months prior to the assessment; and (b) data was available in at least one of the follow-up assessments

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Each participant was assessed over 18 months from enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention- Index	2 of 105 (1.9%)	0 of 105 (0%)	1 of 105
Usual Care Control- Index	0 of 105 (0%)	0 of 105 (0%)	1 of 105
Usual Care Control- Alter	0 of 275 (0%)	0 of 275 (0%)	0 of 275
Intervention- Alter	0 of 324 (0%)	0 of 324 (0%)	3 of 324

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42671691Wagner GJ, Bogart LM, Matovu JKB, Gwokyalya V, Green HD Jr, Ninsiima S, Klein DJ, Okoboi S. Mediators of the effects of an HIV prevention advocacy training intervention on prevention advocacy among persons living with HIV in Uganda. J Behav Med. 2026 Aug 31. doi: 10.1007/s10865-026-00704-z. Online ahead of print.
Derived from this study: PubMed 42176077Wagner GJ, Bogart LM, Okoboi S, Gwokyalya V, Green HD, Klein DJ, Ninsiima S, Matovu JKB. HIV Disclosure and Prevention Advocacy Partially Mediate Advocacy Training Intervention Effect on Reduced Internalized HIV Stigma. AIDS Behav. 2026 May 23:10.1007/s10461-026-05179-2. doi: 10.1007/s10461-026-05179-2. Online ahead of print.
Derived from this study: PubMed 41214256Bogart 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. 2026 Apr;30(4):1007-1021. doi: 10.1007/s10461-025-04907-4. Epub 2025 Nov 11.
Derived from this study: PubMed 35346329Wagner 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.
Individual participant dataSharing planned: Yes. A de-identified dataset will be made available upon review of requests from outside researchers

Related trials for HIV Prevention

Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Glenn Wagner principal investigator

RAND

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Game Changers in people with HIV Prevention, run by RAND at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV Testing (time frame: Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05098015, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.