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| Name | Class |
|---|---|
| Infectious Diseases Institute, Uganda | OTHER |
| Makerere University | OTHER |
| Indiana University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention- index | Experimental | 8-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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Wagner | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Institute | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42176077 | Derived | 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. doi: 10.1007/s10461-026-05179-2. Online ahead of print. | |
| 41214256 | Derived |
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A de-identified dataset will be made available upon review of requests from outside researchers
Following publication of primary results of the study (approximately August 2026).
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Both index participants (PLWH) and alter participants were enrolled; as all index participants were asked to recruit up to 4 alters, each index participant may have any where from 0 to 4 alters enrolled in the study. 210 index (PLWH) participants enrolled and 599 alters enrolled.
The flowchart includes statistics on the number of index and alter participants enrolled and completed within each arm.
PLWH are the index participants, and each enrolled index participant was asked to recruit up to 4 social network members (alters) to also enroll in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention- Index | 8-session group intervention to train index participants to engage in HIV prevention advocacy. Game Changers: 8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy. |
| FG001 | Usual Care Control- Index | Participants will receive HIV usual care, and no added intervention. |
| FG002 | Intervention- Alter | Alter participants recruited by enrolled index participants assigned to receive the intervention comprise this group; however, these alter participants did not receive any intervention |
| FG003 | Usual Care Control- Alter | Alter participants recruited by enrolled index participants assigned to the usual care control group comprise this arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled index and alter participants were part of analysis population
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention- Index | 8-session group intervention to train index participants to engage in HIV prevention advocacy. Game Changers: 8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | percentage of alters | Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18) |
|
Each participant was assessed over 18 months from enrollment.
Adverse events were assessed for all index (PLWH) and alter participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention- Index | 8-session group intervention to train participants to engage in HIV prevention advocacy. Game Changers: 8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| domestic violence | Injury, poisoning and procedural complications | domestic violence | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Glenn Wagner | RAND | 310-393-0411 | gwagner@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2021 | Sep 15, 2025 | Prot_SAP_000.pdf |
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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
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The assessment interviewer will be blinded to study arm allocation of the participants at baseline only.
| 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) |
| 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. |
| 35346329 | 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. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Usual Care Control- Index |
Participants will receive HIV usual care, and no added intervention. |
| BG002 | Usual Care Control- Alter | Alter participants recruited by enrolled index participants assigned to the usual care control group |
| BG003 | Intervention- Alter | Alter participants recruited by enrolled index participants assigned to the intervention group; however, these alter participants did not receive any intervention |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time since HIV diagnosis | This measure was only assessed among index participants (in both the intervention-index and usual care control-index arms), all of whom were persons living with HIV | Mean | Standard Deviation | years |
|
| OG000 |
| Intervention- Index |
8-session group intervention to train participants to engage in HIV prevention advocacy. Game Changers: 8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy. |
| OG001 | Usual Care Control- Index | Participants will receive HIV usual care, and no added intervention. |
|
|
|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | percentage of alters | Reports of always using condoms in the past 6 months, as assessed at each follow-up assessment (Month 6, Month 12, Month 18) |
|
|
|
|
| Secondary | 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 | The Participant Flow included data from all index (PLWH) and alter participants, but this measure was only assessed among index participants. Index participants were included in the analysis if they provided data on the measure in at least one follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Reported at each follow-up assessment (Months 6, 12, 18) |
|
|
|
|
| Secondary | 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 | The Participant Flow included data from all index (PLWH) and alter participants, but this measure was only assessed among index participants. Index participants were included in the analysis if they provided data on the measure in at least one follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Past 6 months as assessed at each follow-up (Months 6, 12, 18) |
|
|
|
|
| 1 |
| 105 |
| 2 |
| 105 |
| 0 |
| 105 |
| EG001 | Usual Care Control- Index | Participants will receive HIV usual care, and no added intervention. | 1 | 105 | 0 | 105 | 0 | 105 |
| EG002 | Usual Care Control- Alter | Alter participants recruited by index participants assigned to the usual care control group comprise this arm | 0 | 275 | 0 | 275 | 0 | 275 |
| EG003 | Intervention- Alter | Alter participants recruited by index participants assigned to the intervention group comprise this arm; however, these alter participants did not receive an intervention | 3 | 324 | 0 | 324 | 0 | 324 |
| loss of job | Social circumstances | loss of job | Non-systematic Assessment |
|
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|