Skip to content

Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03435497
Enrollment
99
Registered
2018-02-19
Start date
2018-04-16
Completion date
2019-07-31
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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

BEHAVIORALGame 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.

Sponsors

Infectious Diseases Institute, Uganda
CollaboratorOTHER
RAND
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Change in Engagement HIV Prevention AdvocacyPast 3 months, measured at baseline and 5 and 8 months post-baselineSelf-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

MeasureTime frameDescription
Change in Sexual Risk Behavior Among AltersMeasured at baseline and 5 and 8 months post-baselineIncreased percentage of self-reported condom use with main partner in past 3 months
Change in HIV Treatment AdherenceMeasured at baseline and 5 and 8 months post-baselineIncreased antiretroviral treatment adherence (self-reported % doses taken in past month)
Change in Internalized HIV StigmaMeasured at baseline and 5 and 8 months post-baselineDecreased 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 PartnerMeasured at baseline and 5 and 8 months post-baselineIncreased 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

ArmCount
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
Total98

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath10
Overall StudyLost to Follow-up10
Overall StudyWithdrawal by Subject04
Overall StudyWrong survey administered02

Baseline characteristics

CharacteristicTotalGame Changers InterventionControl
Age, Continuous35.4 years
STANDARD_DEVIATION 10.5
33.8 years
STANDARD_DEVIATION 10.7
37.1 years
STANDARD_DEVIATION 10
Disclosure to main partner/spouse91 Participants46 Participants45 Participants
Engagement HIV Prevention Advocacy4.0 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 Stigma1.8 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 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
98 Participants51 Participants47 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Uganda
98 participants51 participants47 participants
Sex: Female, Male
Female
52 Participants27 Participants25 Participants
Sex: Female, Male
Male
46 Participants24 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 510 / 47
other
Total, other adverse events
0 / 510 / 47
serious
Total, serious adverse events
0 / 510 / 47

Outcome results

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).

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%.

ArmMeasureGroupValue (MEAN)Dispersion
Game Changers InterventionChange in Engagement HIV Prevention AdvocacyBaseline4.1 units on a scaleStandard Deviation 0.9
Game Changers InterventionChange in Engagement HIV Prevention Advocacy5-Month Followup4.2 units on a scaleStandard Deviation 0.9
Game Changers InterventionChange in Engagement HIV Prevention Advocacy8-month Followup4.0 units on a scaleStandard Deviation 1
ControlChange in Engagement HIV Prevention AdvocacyBaseline3.8 units on a scaleStandard Deviation 1
ControlChange in Engagement HIV Prevention Advocacy5-Month Followup3.5 units on a scaleStandard Deviation 1.1
ControlChange in Engagement HIV Prevention Advocacy8-month Followup3.6 units on a scaleStandard Deviation 1
p-value: 0.017Regression, Linear
Secondary

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%.

ArmMeasureGroupValue (MEAN)Dispersion
Game Changers InterventionChange in HIV Treatment AdherenceBaseline.91 mean % of prescribed doses takenStandard Deviation 0.09
Game Changers InterventionChange in HIV Treatment Adherence5-Month Followup.92 mean % of prescribed doses takenStandard Deviation 0.09
Game Changers InterventionChange in HIV Treatment Adherence8-month Followup.95 mean % of prescribed doses takenStandard Deviation 0.06
ControlChange in HIV Treatment AdherenceBaseline.93 mean % of prescribed doses takenStandard Deviation 0.08
ControlChange in HIV Treatment Adherence5-Month Followup.93 mean % of prescribed doses takenStandard Deviation 0.1
ControlChange in HIV Treatment Adherence8-month Followup.93 mean % of prescribed doses takenStandard Deviation 0.12
p-value: 0.48Regression, Linear
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)

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%.

ArmMeasureGroupValue (MEAN)Dispersion
Game Changers InterventionChange in Internalized HIV StigmaBaseline1.7 units on a scaleStandard Deviation 0.7
Game Changers InterventionChange in Internalized HIV Stigma5-Month Followup1.6 units on a scaleStandard Deviation 0.6
Game Changers InterventionChange in Internalized HIV Stigma8-month Followup1.4 units on a scaleStandard Deviation 0.6
ControlChange in Internalized HIV StigmaBaseline1.8 units on a scaleStandard Deviation 0.8
ControlChange in Internalized HIV Stigma5-Month Followup1.9 units on a scaleStandard Deviation 0.7
ControlChange in Internalized HIV Stigma8-month Followup1.7 units on a scaleStandard Deviation 0.8
p-value: 0.012Regression, Linear
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Game Changers InterventionChange in Sexual Risk Behavior Among Alters5-Month Followup13 Participants
Game Changers InterventionChange in Sexual Risk Behavior Among Alters8-month Followup16 Participants
ControlChange in Sexual Risk Behavior Among Alters5-Month Followup14 Participants
ControlChange in Sexual Risk Behavior Among Alters8-month Followup12 Participants
p-value: 0.0595% CI: [0.2, 1.6]Regression, Logistic
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).

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%.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Game Changers InterventionNumber of Participants Who Have Reported Their HIV Status to Their Main PartnerBaseline31 Participants
Game Changers InterventionNumber of Participants Who Have Reported Their HIV Status to Their Main Partner5-Month Followup29 Participants
Game Changers InterventionNumber of Participants Who Have Reported Their HIV Status to Their Main Partner8-month Followup31 Participants
ControlNumber of Participants Who Have Reported Their HIV Status to Their Main PartnerBaseline30 Participants
ControlNumber of Participants Who Have Reported Their HIV Status to Their Main Partner5-Month Followup28 Participants
ControlNumber of Participants Who Have Reported Their HIV Status to Their Main Partner8-month Followup27 Participants
p-value: 0.02295% CI: [1.5, 67.7]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026