Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

NCT03435497 | Completed Results

• 1 other identifier: R34MH111460
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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. 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).

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Change in Engagement HIV Prevention Advocacy

  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).

  Past 3 months, measured at baseline and 5 and 8 months post-baseline

Secondary Outcomes (4)

• Change in Sexual Risk Behavior Among Alters

  Measured at baseline and 5 and 8 months post-baseline

• Change in HIV Treatment Adherence

  Measured at baseline and 5 and 8 months post-baseline

• Change in Internalized HIV Stigma

  Measured at baseline and 5 and 8 months post-baseline

• Number of Participants Who Have Reported Their HIV Status to Their Main Partner

  Measured at baseline and 5 and 8 months post-baseline

Study Arms (2)

Game Changers Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Game Changers BEHAVIORAL

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.

Game Changers Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old
• In HIV care for \> 1 year
• Having disclosed serostatus to at least one person
• + years old
• Referred by a patient participant because they are family members, friends, or other people in patients' social network
• knows patient participant's serostatus

Sponsors & Collaborators

• RAND: lead
• Infectious Diseases Institute, Uganda: collaborator

Study Sites (1)

Infectious Diseases Institute

Kampala, Uganda

Location

Results Point of Contact

• Title: Laura Bogart, PhD
• Organization: RAND Corporation

lbogart@rand.org

3103930411

Study Officials

• Laura Bogart, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 19, 2018
• Study Start: April 16, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: June 18, 2020
• Results First Posted: June 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)