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Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435497
Recruitment Status : Completed
First Posted : February 19, 2018
Results First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
Infectious Diseases Institute, Uganda
Information provided by (Responsible Party):
RAND

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
HIV Behavioral: Game Changers Not Applicable

Detailed Description:
People living with HIV (PLWH) have a critical role to play in HIV prevention, not only in the context of Prevention for Positives and Treatment as Prevention, but as powerful change agents for HIV protective behaviors among others. Our research suggests that as PLWH receive HIV treatment and restore their health and functioning, many are motivated to protect their loved ones and engage in prevention advocacy (i.e., to encourage friends and family to seek HIV testing and treatment, and to reduce risk behavior); however, the quality of this advocacy is hampered by challenges related to message content, style and timing of delivery, and selection of advocacy recipients. With effective advocacy training, mobilizing PLWH to be change agents within their social networks has the potential to be a "game changer" for HIV prevention, particularly in high prevalence settings such as Uganda, where virtually every family is touched by someone living with HIV. Drawing upon theoretical frameworks for network-based interventions, such as theories of social diffusion, cognitive consistency, and social influence, the proposed study will develop and pilot test "Game Changers"-- an intervention that aims to empower and mobilize PLWH to be agents for HIV prevention and behavioral change in their social networks. In Phase 1, separate focus groups of PLWH and members of their social networks (family and friends) were conducted to explore barriers to and facilitators of mobilizing clients to advocate for HIV prevention, perceptions on how advocacy could be most effective in motivating behavior change, and how to best structure the intervention and its content. In Phase 2 findings from Phase 1 and network-based intervention models were used to develop the structure and content of an intervention designed to help clients cope with stigma, manage their disease, live positively, and develop motivation and skills for HIV disclosure and prevention advocacy. In Phase 3 a pilot group intervention will be conducted in a controlled trial of 96 clients, with 48 randomly assigned to receive the intervention and 48 to the wait-list control. Assessments will be administered to all participants at baseline, 5 months later, and again 8 months after baseline, after which the control group will receive the intervention (but not the interviews). PLWH interviews and social network assessments will examine intervention effects on protective behaviors of the participant (condom use, HIV treatment adherence), and 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. At the end of the intervention period a focus group with program participants will be conducted to get feedback on the intervention. To help understand how participation in the program might affect health, date of HIV diagnosis, last two CD4 counts and HIV viral loads, and prescribed HIV medications will be obtained from PLWH participant medical charts. Participants (about 15/arm) will be asked to recruit up to 3 alters each, who know the participant's serostatus, to be interviewed to assess their HIV protective behaviors (e.g., condom use) and receipt of prevention advocacy from the intervention participant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (People living with HIV):

  • 18+ years old
  • In HIV care for > 1 year
  • Having disclosed serostatus to at least one person

Inclusion Criteria (Social network members):

  • 18+ 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

Exclusion Criteria:

  • Individuals who meet the inclusion criteria above will be eligible to participate, and no other exclusion criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435497


Locations
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Uganda
Infectious Diseases Institute
Kampala, Uganda
Sponsors and Collaborators
RAND
Infectious Diseases Institute, Uganda
Investigators
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Principal Investigator: Laura Bogart, PhD RAND
  Study Documents (Full-Text)

Documents provided by RAND:
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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT03435497    
Other Study ID Numbers: R34MH111460 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2018    Key Record Dates
Results First Posted: June 18, 2020
Last Update Posted: June 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No