NCT03435497

Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

Completed NA Results posted Last updated 18 June 2020

What this trial tests

NA trial testing Game Changers in HIV in 99 participants. Completed in 31 July 2019.

Timeline

16 April 2018

Primary endpoint
31 July 2019

31 July 2019

Quick facts

Lead sponsor	RAND
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	99
Start date	16 April 2018
Primary completion	31 July 2019
Estimated completion	31 July 2019
Sites	1 location across Uganda

Drugs / interventions tested

• Game Changers

Conditions studied

• HIV — all drugs for HIV →

Sponsor

RAND — full company profile →

Who can join

18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Engagement HIV Prevention Advocacy Primary · Past 3 months, measured at baseline and 5 and 8 months post-baseline

Self-reported communication with social network members about protective behaviors. This is a composite of 14 survey items rated on a scale of 1 (low level of communication) to 5 (high level of communication).

Baseline

Group	Value	95% CI
Game Changers Intervention	4.1	± 0.9
Control	3.8	± 1.0

5-Month Followup

Group	Value	95% CI
Game Changers Intervention	4.2	± 0.9
Control	3.5	± 1.1

8-month Followup

Group	Value	95% CI
Game Changers Intervention	4.0	± 1.0
Control	3.6	± 1.0

Change in Sexual Risk Behavior Among Alters Secondary · Measured at baseline and 5 and 8 months post-baseline

Increased percentage of self-reported condom use with main partner in past 3 months

5-Month Followup

Group	Value	95% CI
Game Changers Intervention	13
Control	14

8-month Followup

Group	Value	95% CI
Game Changers Intervention	16
Control	12

Change in HIV Treatment Adherence Secondary · Measured at baseline and 5 and 8 months post-baseline

Increased antiretroviral treatment adherence (self-reported % doses taken in past month)

Baseline

Group	Value	95% CI
Game Changers Intervention	.91	± .09
Control	.93	± .08

5-Month Followup

Group	Value	95% CI
Game Changers Intervention	.92	± .09
Control	.93	± .10

8-month Followup

Group	Value	95% CI
Game Changers Intervention	.95	± .06
Control	.93	± .12

Change in Internalized HIV Stigma Secondary · Measured at baseline and 5 and 8 months post-baseline

Decreased rates of internalized HIV-related stigma on Internalized AIDS Stigma Scale (range=1-5, higher values = high stigma)

Baseline

Group	Value	95% CI
Game Changers Intervention	1.7	± .7
Control	1.8	± .8

5-Month Followup

Group	Value	95% CI
Game Changers Intervention	1.6	± 0.6
Control	1.9	± 0.7

8-month Followup

Group	Value	95% CI
Game Changers Intervention	1.4	± 0.6
Control	1.7	± 0.8

Number of Participants Who Have Reported Their HIV Status to Their Main Partner Secondary · Measured at baseline and 5 and 8 months post-baseline

Increased self-reported rates of HIV status disclosure: Participants were asked if they had disclosed their HIV-serostatus to their main partner or spouse (yes/no).

Baseline

Group	Value	95% CI
Game Changers Intervention	31
Control	30

5-Month Followup

Group	Value	95% CI
Game Changers Intervention	29
Control	28

8-month Followup

Group	Value	95% CI
Game Changers Intervention	31
Control	27

Sponsor's own description

This randomized controlled pilot study of the "Game Changers" program will:

1. Assess the feasibility and acceptability of implementing an HIV prevention advocacy intervention with people living with HIV who are in HIV care, and who will be trained to be advocates of HIV protective behaviors within their social networks.
2. Assess preliminary intervention effects on a) protective behavior of the HIV-positive clients (condom use, partner concurrency/number of partners, engagement in HIV care, ART adherence); and b) diffusion of prevention messages across the network, as assessed by the content and extent of communication with network members about protective behaviors (condom use, partner concurrency/number of partners, HIV testing, engagement in HIV care, circumcision), HIV disclosure, and HIV stigma.
3. Explore characteristics of HIV-positive clients who more effectively engage in prevention advocacy (in terms of socio-demographics, network characteristics, and network position and type of alters receiving advocacy).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Association of Condom Use Advocacy with Perceived Condom Use Among Social Network Members: The Mediating Role of Advocates' Internalized HIV Stigma and Own Condom Use.
   Wagner GJ, Bogart LM, Klein DJ, Green HD, et al · · 2022 · cited 7× · PMID 35091879 · DOI 10.1007/s10461-022-03601-z
2. Examination of Mediators and Moderators to Understand How and in What Context Game Changers Increases HIV Prevention Advocacy Among Persons Living With HIV in Uganda.
   Wagner GJ, Bogart LM, Klein DJ, Green HD, et al · · 2021 · cited 4× · PMID 33791991 · DOI 10.1007/s12529-021-09983-z
3. Randomized Controlled Trial of Game Changers, a Social Network Intervention for HIV Prevention in Uganda.
   Bogart LM, Matovu JKB, Green HD, Ninsiima S, et al · · 2026 · PMID 41214256 · DOI 10.1007/s10461-025-04907-4