Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda
|ClinicalTrials.gov Identifier: NCT03435497|
Recruitment Status : Completed
First Posted : February 19, 2018
Results First Posted : June 18, 2020
Last Update Posted : June 18, 2020
This randomized controlled pilot study of the "Game Changers" program will:
- 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.
- 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.
- 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).
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Game Changers||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Game Changers: Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda|
|Actual Study Start Date :||April 16, 2018|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
Experimental: Game Changers Intervention
Game Changers is an intervention that aims to empower and mobilize people living with HIV to be agents for HIV prevention and behavioral change in their social networks.
Behavioral: Game Changers
Game Changers is an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks.
No Intervention: Control
The control group will receive standard of care during the intervention assessment period. All control participants will be offered the Game Changers program once all assessments for the primary study outcomes have been completed.
- Change in Engagement HIV Prevention Advocacy [ Time Frame: 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).
- Change in Sexual Risk Behavior Among Alters [ Time Frame: Measured at baseline and 5 and 8 months post-baseline ]Increased percentage of self-reported condom use with main partner in past 3 months
- Change in HIV Treatment Adherence [ Time Frame: Measured at baseline and 5 and 8 months post-baseline ]Increased antiretroviral treatment adherence (self-reported % doses taken in past month)
- Change in Internalized HIV Stigma [ Time Frame: 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)
- Number of Participants Who Have Reported Their HIV Status to Their Main Partner [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435497
|Infectious Diseases Institute|
|Principal Investigator:||Laura Bogart, PhD||RAND|