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HIVNCT03435497

Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

A study testing Game Changers in people with HIV, run by RAND at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Game Changers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteUganda
Study dates
16 Apr 2018to 31 Jul 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Uganda1 site
  • Infectious Diseases Institute

    Kampala

Other trials in Uganda

About this study

Official title: Game Changers: Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

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).
Read the 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.

Conditions
HIV
Being tested
Game Changers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Game ChangersBehavioural

    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.

Study groups in NCT03435497
Study groupRoleWhat they receive
Game Changers InterventionExperimentalGame 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.
Receives: Behavioral: Game Changers
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (4)
  1. Change in Sexual Risk Behavior Among Alters

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

    Measured: Measured at baseline and 5 and 8 months post-baseline

  2. Change in HIV Treatment Adherence

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

    Measured: Measured at baseline and 5 and 8 months post-baseline

  3. Change in Internalized HIV Stigma

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

    Measured: Measured at baseline and 5 and 8 months post-baseline

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

    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).

    Measured: Measured at baseline and 5 and 8 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start16 Apr 2018
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03435497
Sponsor's protocol ID
R34MH111460
Status last verified
May 2020
First submitted
8 Feb 2018
Last updated
18 Jun 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Game Changers in people with HIV, run by RAND at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Engagement HIV Prevention Advocacy (time frame: Past 3 months, measured at baseline and 5 and 8 months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.

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