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| Name | Class |
|---|---|
| Infectious Diseases Institute, Uganda | OTHER |
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This randomized controlled pilot study of the "Game Changers" program will:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sexual Risk Behavior Among Alters | Increased percentage of self-reported condom use with main partner in past 3 months | Measured at baseline and 5 and 8 months post-baseline |
| Change in HIV Treatment Adherence |
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Inclusion Criteria (People living with HIV):
Inclusion Criteria (Social network members):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Bogart, PhD | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Institute | Kampala | Uganda |
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1 control was withdrawn because she was exposed to the intervention after randomization. Of the 98 remaining, 1 control did not provide any follow-up data due to moving away from the study area. 4 participants who provided first follow-up data did not provide last follow-up data (2 intervention, 2 control). Retention rate=99%
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 1 control participant did not provide any follow-up data due to moving away from the study area. 2 intervention and 2 control participants who provided follow-up data at 5-months post-baseline did not provide follow-up data at 8-months post-baseline. The retention rate for any follow-up data was 99%, and at last follow-up was 95%. | Posted | Mean | Standard Deviation | units on a scale | Past 3 months, measured at baseline and 5 and 8 months post-baseline |
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Approximately 1 year, 4 months (April 2018 - July 2019)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Bogart, PhD | RAND Corporation | 3103930411 | 7281 | lbogart@rand.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2018 | May 26, 2020 | Prot_SAP_001.pdf |
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Increased antiretroviral treatment adherence (self-reported % doses taken in past month)
| Measured at baseline and 5 and 8 months post-baseline |
| 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 at baseline and 5 and 8 months post-baseline |
| 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 at baseline and 5 and 8 months post-baseline |
| Withdrawal by Subject |
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| Wrong survey administered |
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| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Engagement HIV Prevention Advocacy | Self-reported communication with social network members about protective behaviors: participants asked how much they discussed eight different topics (e.g., HIV testing, condom use) with people they know in the past 3 months, from 1, not at all to 5, very much | Mean | Standard Deviation | units on a scale |
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| Internalized HIV Stigma | Composite of 6 survey items rated on a scale of 1 (low) to 5 (high) | Mean | Standard Deviation | units on a scale (1-5) |
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| Disclosure to main partner/spouse | Count of Participants | Participants |
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| HIV Treatment Adherence Percentage | Self-reported percentage of prescribed HIV antiretroviral medications taken in the past month | Mean | Standard Deviation | mean % of prescribed medication taken |
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| OG001 | 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. |
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| Secondary | Change in Sexual Risk Behavior Among Alters | Increased percentage of self-reported condom use with main partner in past 3 months | We contacted 135 alters, 17 were already enrolled; 1 was withdrawn because the referring participant was exposed to the intervention. Of the remaining 117, 34 could not be reached, and 26 declined. Thus, 56 alters participated (35 referred by intervention participants, 21 referred by control). Alters were not included in the enrollment number. | Posted | Count of Participants | Participants | Measured at baseline and 5 and 8 months post-baseline |
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| Secondary | Change in HIV Treatment Adherence | Increased antiretroviral treatment adherence (self-reported % doses taken in past month) | 1 control participant did not provide any follow-up data due to moving away from the study area. 2 intervention and 2 control participants who provided follow-up data at 5-months post-baseline did not provide follow-up data at 8-months post-baseline. The retention rate for any follow-up data was 99%, and at last follow-up was 95%. | Posted | Mean | Standard Deviation | mean % of prescribed doses taken | Measured at baseline and 5 and 8 months post-baseline |
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| Secondary | Change in Internalized HIV Stigma | Decreased rates of internalized HIV-related stigma on Internalized AIDS Stigma Scale (range=1-5, higher values = high stigma) | 1 control participant did not provide any follow-up data due to moving away from the study area. 2 intervention and 2 control participants who provided follow-up data at 5-months post-baseline did not provide follow-up data at 8-months post-baseline. The retention rate for any follow-up data was 99%, and at last follow-up was 95%. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and 5 and 8 months post-baseline |
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| Secondary | 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). | 1 control participant did not provide any follow-up data due to moving away from the study area. 2 intervention and 2 control participants who provided follow-up data at 5-months post-baseline did not provide follow-up data at 8-months post-baseline. The retention rate for any follow-up data was 99%, and at last follow-up was 95%. | Posted | Count of Participants | Participants | Measured at baseline and 5 and 8 months post-baseline |
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| 1 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | 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. | 0 | 47 | 0 | 47 | 0 | 47 |
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| 5-Month Followup |
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| 8-month Followup |
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| 5-Month Followup |
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| 8-month Followup |
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| 8-month Followup |
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