HIV
Conditions
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).
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Engagement HIV Prevention Advocacy | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Sexual Risk Behavior Among Alters | 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 | 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 | 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 | 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). |
Countries
Uganda
Participant flow
Pre-assignment details
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%
Participants by arm
| Arm | Count |
|---|---|
| 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. | 51 |
| 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. | 47 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
| Overall Study | Wrong survey administered | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Game Changers Intervention | Control |
|---|---|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 10.5 | 33.8 years STANDARD_DEVIATION 10.7 | 37.1 years STANDARD_DEVIATION 10 |
| Disclosure to main partner/spouse | 91 Participants | 46 Participants | 45 Participants |
| Engagement HIV Prevention Advocacy | 4.0 units on a scale STANDARD_DEVIATION 1 | 4.1 units on a scale STANDARD_DEVIATION 0.9 | 3.8 units on a scale STANDARD_DEVIATION 1 |
| HIV Treatment Adherence Percentage | .9 mean % of prescribed medication taken STANDARD_DEVIATION 0.1 | 0.9 mean % of prescribed medication taken STANDARD_DEVIATION 0.1 | .9 mean % of prescribed medication taken STANDARD_DEVIATION 0.1 |
| Internalized HIV Stigma | 1.8 units on a scale (1-5) STANDARD_DEVIATION 0.7 | 1.7 units on a scale (1-5) STANDARD_DEVIATION 0.7 | 1.8 units on a scale (1-5) STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 98 Participants | 51 Participants | 47 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Uganda | 98 participants | 51 participants | 47 participants |
| Sex: Female, Male Female | 52 Participants | 27 Participants | 25 Participants |
| Sex: Female, Male Male | 46 Participants | 24 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 51 | 0 / 47 |
| other Total, other adverse events | 0 / 51 | 0 / 47 |
| serious Total, serious adverse events | 0 / 51 | 0 / 47 |
Outcome results
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).
Time frame: Past 3 months, measured at baseline and 5 and 8 months post-baseline
Population: 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%.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Game Changers Intervention | Change in Engagement HIV Prevention Advocacy | Baseline | 4.1 units on a scale | Standard Deviation 0.9 |
| Game Changers Intervention | Change in Engagement HIV Prevention Advocacy | 5-Month Followup | 4.2 units on a scale | Standard Deviation 0.9 |
| Game Changers Intervention | Change in Engagement HIV Prevention Advocacy | 8-month Followup | 4.0 units on a scale | Standard Deviation 1 |
| Control | Change in Engagement HIV Prevention Advocacy | Baseline | 3.8 units on a scale | Standard Deviation 1 |
| Control | Change in Engagement HIV Prevention Advocacy | 5-Month Followup | 3.5 units on a scale | Standard Deviation 1.1 |
| Control | Change in Engagement HIV Prevention Advocacy | 8-month Followup | 3.6 units on a scale | Standard Deviation 1 |
Change in HIV Treatment Adherence
Increased antiretroviral treatment adherence (self-reported % doses taken in past month)
Time frame: Measured at baseline and 5 and 8 months post-baseline
Population: 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%.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Game Changers Intervention | Change in HIV Treatment Adherence | Baseline | .91 mean % of prescribed doses taken | Standard Deviation 0.09 |
| Game Changers Intervention | Change in HIV Treatment Adherence | 5-Month Followup | .92 mean % of prescribed doses taken | Standard Deviation 0.09 |
| Game Changers Intervention | Change in HIV Treatment Adherence | 8-month Followup | .95 mean % of prescribed doses taken | Standard Deviation 0.06 |
| Control | Change in HIV Treatment Adherence | Baseline | .93 mean % of prescribed doses taken | Standard Deviation 0.08 |
| Control | Change in HIV Treatment Adherence | 5-Month Followup | .93 mean % of prescribed doses taken | Standard Deviation 0.1 |
| Control | Change in HIV Treatment Adherence | 8-month Followup | .93 mean % of prescribed doses taken | Standard Deviation 0.12 |
Change in Internalized HIV Stigma
Decreased rates of internalized HIV-related stigma on Internalized AIDS Stigma Scale (range=1-5, higher values = high stigma)
Time frame: Measured at baseline and 5 and 8 months post-baseline
Population: 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%.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Game Changers Intervention | Change in Internalized HIV Stigma | Baseline | 1.7 units on a scale | Standard Deviation 0.7 |
| Game Changers Intervention | Change in Internalized HIV Stigma | 5-Month Followup | 1.6 units on a scale | Standard Deviation 0.6 |
| Game Changers Intervention | Change in Internalized HIV Stigma | 8-month Followup | 1.4 units on a scale | Standard Deviation 0.6 |
| Control | Change in Internalized HIV Stigma | Baseline | 1.8 units on a scale | Standard Deviation 0.8 |
| Control | Change in Internalized HIV Stigma | 5-Month Followup | 1.9 units on a scale | Standard Deviation 0.7 |
| Control | Change in Internalized HIV Stigma | 8-month Followup | 1.7 units on a scale | Standard Deviation 0.8 |
Change in Sexual Risk Behavior Among Alters
Increased percentage of self-reported condom use with main partner in past 3 months
Time frame: Measured at baseline and 5 and 8 months post-baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Game Changers Intervention | Change in Sexual Risk Behavior Among Alters | 5-Month Followup | 13 Participants |
| Game Changers Intervention | Change in Sexual Risk Behavior Among Alters | 8-month Followup | 16 Participants |
| Control | Change in Sexual Risk Behavior Among Alters | 5-Month Followup | 14 Participants |
| Control | Change in Sexual Risk Behavior Among Alters | 8-month Followup | 12 Participants |
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).
Time frame: Measured at baseline and 5 and 8 months post-baseline
Population: 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%.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Game Changers Intervention | Number of Participants Who Have Reported Their HIV Status to Their Main Partner | Baseline | 31 Participants |
| Game Changers Intervention | Number of Participants Who Have Reported Their HIV Status to Their Main Partner | 5-Month Followup | 29 Participants |
| Game Changers Intervention | Number of Participants Who Have Reported Their HIV Status to Their Main Partner | 8-month Followup | 31 Participants |
| Control | Number of Participants Who Have Reported Their HIV Status to Their Main Partner | Baseline | 30 Participants |
| Control | Number of Participants Who Have Reported Their HIV Status to Their Main Partner | 5-Month Followup | 28 Participants |
| Control | Number of Participants Who Have Reported Their HIV Status to Their Main Partner | 8-month Followup | 27 Participants |