Trial Outcomes & Findings for Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda (NCT NCT03435497)

Last Updated: 2020-06-18

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

99 participants

Primary outcome timeframe

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

Results posted on

2020-06-18

Participant Flow

1 control was withdrawn because she was exposed to the intervention after randomization.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%

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	51	47
Overall Study COMPLETED	49	41
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	1	0
Overall Study Death	1	0
Overall Study Withdrawal by Subject	0	4
Overall Study Wrong survey administered	0	2

Baseline Characteristics

Pilot Intervention to Empower HIV Clients as Prevention Advocates in Uganda

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Game Changers Intervention n=51 Participants 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.	Control n=47 Participants 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.	Total n=98 Participants Total of all reporting groups
Age, Continuous	33.8 years STANDARD_DEVIATION 10.7 • n=93 Participants	37.1 years STANDARD_DEVIATION 10.0 • n=4 Participants	35.4 years STANDARD_DEVIATION 10.5 • n=27 Participants
Sex: Female, Male Female	27 Participants n=93 Participants	25 Participants n=4 Participants	52 Participants n=27 Participants
Sex: Female, Male Male	24 Participants n=93 Participants	22 Participants n=4 Participants	46 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	51 Participants n=93 Participants	47 Participants n=4 Participants	98 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Uganda	51 participants n=93 Participants	47 participants n=4 Participants	98 participants n=27 Participants
Engagement HIV Prevention Advocacy	4.1 units on a scale STANDARD_DEVIATION 0.9 • n=93 Participants	3.8 units on a scale STANDARD_DEVIATION 1.0 • n=4 Participants	4.0 units on a scale STANDARD_DEVIATION 1.0 • n=27 Participants
Internalized HIV Stigma	1.7 units on a scale (1-5) STANDARD_DEVIATION 0.7 • n=93 Participants	1.8 units on a scale (1-5) STANDARD_DEVIATION 0.8 • n=4 Participants	1.8 units on a scale (1-5) STANDARD_DEVIATION 0.7 • n=27 Participants
Disclosure to main partner/spouse	46 Participants n=93 Participants	45 Participants n=4 Participants	91 Participants n=27 Participants
HIV Treatment Adherence Percentage	0.9 mean % of prescribed medication taken STANDARD_DEVIATION 0.1 • n=93 Participants	.9 mean % of prescribed medication taken STANDARD_DEVIATION .1 • n=4 Participants	.9 mean % of prescribed medication taken STANDARD_DEVIATION .1 • n=27 Participants

PRIMARY outcome

Timeframe: 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%.

Outcome measures

Outcome measures
Measure	Game Changers Intervention n=51 Participants 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.	Control n=46 Participants 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.
Change in Engagement HIV Prevention Advocacy Baseline	4.1 units on a scale Standard Deviation 0.9	3.8 units on a scale Standard Deviation 1.0
Change in Engagement HIV Prevention Advocacy 5-Month Followup	4.2 units on a scale Standard Deviation 0.9	3.5 units on a scale Standard Deviation 1.1
Change in Engagement HIV Prevention Advocacy 8-month Followup	4.0 units on a scale Standard Deviation 1.0	3.6 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Game Changers Intervention n=35 Participants 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.	Control n=21 Participants 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.
Change in Sexual Risk Behavior Among Alters 5-Month Followup	13 Participants	14 Participants
Change in Sexual Risk Behavior Among Alters 8-month Followup	16 Participants	12 Participants

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Game Changers Intervention n=50 Participants 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.	Control n=46 Participants 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.
Change in HIV Treatment Adherence Baseline	.91 mean % of prescribed doses taken Standard Deviation .09	.93 mean % of prescribed doses taken Standard Deviation .08
Change in HIV Treatment Adherence 5-Month Followup	.92 mean % of prescribed doses taken Standard Deviation .09	.93 mean % of prescribed doses taken Standard Deviation .10
Change in HIV Treatment Adherence 8-month Followup	.95 mean % of prescribed doses taken Standard Deviation .06	.93 mean % of prescribed doses taken Standard Deviation .12

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Game Changers Intervention n=51 Participants 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.	Control n=46 Participants 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.
Change in Internalized HIV Stigma Baseline	1.7 units on a scale Standard Deviation .7	1.8 units on a scale Standard Deviation .8
Change in Internalized HIV Stigma 5-Month Followup	1.6 units on a scale Standard Deviation 0.6	1.9 units on a scale Standard Deviation 0.7
Change in Internalized HIV Stigma 8-month Followup	1.4 units on a scale Standard Deviation 0.6	1.7 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Game Changers Intervention n=31 Participants 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.	Control n=30 Participants 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.
Number of Participants Who Have Reported Their HIV Status to Their Main Partner 5-Month Followup	29 Participants	28 Participants
Number of Participants Who Have Reported Their HIV Status to Their Main Partner 8-month Followup	31 Participants	27 Participants
Number of Participants Who Have Reported Their HIV Status to Their Main Partner Baseline	31 Participants	30 Participants

Adverse Events

Game Changers Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laura Bogart, PhD

RAND Corporation

Phone: 3103930411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place