HIV Prevention
Conditions
Brief summary
The study is a randomized controlled trial (RCT) of Game Changers, an 8-session peer-led group intervention that aims to empower and mobilize people living with HIV (PLWH) to be agents for HIV prevention in their social networks.
Detailed description
This RCT of Game Changers, a peer-led group intervention for persons living with HIV (PLWH) in Uganda, will test intervention effects on the primary outcomes of reduced condomless sex, increased HIV testing, and decreased enacted HIV stigma among social network members. We will recruit 210 PLWH, randomizing 105 to the intervention and 105 to an attention control. Each PLWH will be asked to recruit up to 4 social network members to complete assessments (736 total, 368/arm). All participants will complete surveys at baseline and 6-, 12-, and 18-months post-baseline.
Interventions
BEHAVIORALGame Changers
8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy.
Sponsors
Infectious Diseases Institute, Uganda
Makerere University
Indiana University
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessment interviewer will be blinded to study arm allocation of the participants at baseline only.
Intervention model description
Individual randomization of index participants (and their recruited alter participants) to one of two parallel groups, the intervention or usual care (no intervention) control group. Therefore there are 4 study groups: index intervention, alter intervention, index control and alter control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 years and older * HIV-positive * in HIV care at The Infectious DIseases Institute for at least one year
Exclusion criteria
* Participated in the prior pilot study of the intervention. * Has significant cognitive impairment * Health status is not sufficiently stable to reliably complete 18 month study. * Does not speak Luganda fluently (index participant); English or Luganda fluently (social network participant) * spouse/partner or household member are enrolled as index participant in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Testing | Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18) | For each index participant (PLWH), data is examined from their enrolled alters and the percent of these alters who self-reported HIV testing behavior (yes/no) at each follow-up assessment is calculated, followed by the average percent across all follow-up assessments. Therefore, data from all three follow-up timepoints (months 6, 12 18) were pooled and an average calculated across the timepoints. |
| Condom Use | Reports of always using condoms in the past 6 months, as assessed at each follow-up assessment (Month 6, Month 12, Month 18) | For each index participant (PLWH), data is examined from their enrolled alters and the percent of these alters who self-reported always using condoms use during intercourse at each follow-up assessment is calculated, followed by the average percentage across all follow-up assessments. Therefore, data from all three follow-up timepoints (months 6, 12 18) were pooled and an average calculated across the timepoints. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Internalized HIV Stigma | Reported at each follow-up assessment (Months 6, 12, 18) | This outcome is based solely on data from the index participants. Self-reported internalized HIV stigma (on 1-5 scale, with higher scores represented greater stigma); scale score is averaged across all follow-up assessments |
| HIV Prevention Advocacy | Past 6 months as assessed at each follow-up (Months 6, 12, 18) | This outcome is based solely on data from the index participants. Self-reported prevention advocacy (on 1-5 scale, with higher scores representing greater engagement in advocacy); scores are averaged across all follow-up assessments |
Countries
Uganda
Participant flow
Recruitment details
PLWH are the index participants, and each enrolled index participant was asked to recruit up to 4 social network members (alters) to also enroll in the study.
Pre-assignment details
Both index participants (PLWH) and alter participants were enrolled; as all index participants were asked to recruit up to 4 alters, each index participant may have any where from 0 to 4 alters enrolled in the study. 210 index (PLWH) participants enrolled and 599 alters enrolled. The flowchart includes statistics on the number of index and alter participants enrolled and completed within each arm.
Participants by arm
| Arm | Count |
|---|---|
| Intervention- Index 8-session group intervention to train index participants to engage in HIV prevention advocacy.
Game Changers: 8-session group intervention that uses didactic instruction, role plays and experience sharing to empower participants to engage in HIV prevention advocacy. | 105 |
| Usual Care Control- Index Participants will receive HIV usual care, and no added intervention. | 105 |
| Usual Care Control- Alter Alter participants recruited by enrolled index participants assigned to the usual care control group | 275 |
| Intervention- Alter Alter participants recruited by enrolled index participants assigned to the intervention group; however, these alter participants did not receive any intervention | 324 |
| Total | 809 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 3 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Intervention- Index | Total | Intervention- Alter | Usual Care Control- Alter | Usual Care Control- Index |
|---|---|---|---|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 10.7 | 38.0 years STANDARD_DEVIATION 12 | 36.6 years STANDARD_DEVIATION 12.3 | 38.2 years STANDARD_DEVIATION 12.4 | 39.3 years STANDARD_DEVIATION 10.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 105 Participants | 809 Participants | 324 Participants | 275 Participants | 105 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 74 Participants | 544 Participants | 223 Participants | 174 Participants | 73 Participants |
| Sex: Female, Male Male | 31 Participants | 265 Participants | 101 Participants | 101 Participants | 32 Participants |
| Time since HIV diagnosis | 10.8 years STANDARD_DEVIATION 6.1 | 11.0 years STANDARD_DEVIATION 5.6 | — | — | 11.1 years STANDARD_DEVIATION 5.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 105 | 1 / 105 | 0 / 275 | 3 / 324 |
| other Total, other adverse events | 0 / 105 | 0 / 105 | 0 / 275 | 0 / 324 |
| serious Total, serious adverse events | 2 / 105 | 0 / 105 | 0 / 275 | 0 / 324 |
Outcome results
Primary
Condom Use
For each index participant (PLWH), data is examined from their enrolled alters and the percent of these alters who self-reported always using condoms use during intercourse at each follow-up assessment is calculated, followed by the average percentage across all follow-up assessments. Therefore, data from all three follow-up timepoints (months 6, 12 18) were pooled and an average calculated across the timepoints.
Time frame: Reports of always using condoms in the past 6 months, as assessed at each follow-up assessment (Month 6, Month 12, Month 18)
Population: The Participant Flow included data from all index (PLWH) and alter participants, while the outcome measures are based on index-level measures-- for each index participant, the measure reflects data reported by their enrolled alters. Index participants were included in the analysis if (a) at least one of their alters reported engaging in sexual intercourse in the 6 months prior to the assessment; and (b) data was available in at least one of the follow-up assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- Index | Condom Use | 18.04 percentage of alters | Standard Deviation 29.6 |
| Usual Care Control- Index | Condom Use | 13.15 percentage of alters | Standard Deviation 27.06 |
p-value: 0.16Regression, Linear
Primary
HIV Testing
For each index participant (PLWH), data is examined from their enrolled alters and the percent of these alters who self-reported HIV testing behavior (yes/no) at each follow-up assessment is calculated, followed by the average percent across all follow-up assessments. Therefore, data from all three follow-up timepoints (months 6, 12 18) were pooled and an average calculated across the timepoints.
Time frame: Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18)
Population: The Participant Flow included data from all index (PLWH) and alter participants, while the outcome measures are based on index-level measures-- for each index participant, the measure reflects data reported by their enrolled alters. For this specific measure (HIV testing), index participants provided data for analysis if (a) at least one of their alters was not living with HIV at the time of the assessment; and (2) data was present in at least one of the follow-up assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- Index | HIV Testing | 71.60 percentage of alters | Standard Deviation 35.23 |
| Usual Care Control- Index | HIV Testing | 71.61 percentage of alters | Standard Deviation 37.19 |
p-value: 0.95Regression, Linear
Secondary
HIV Prevention Advocacy
This outcome is based solely on data from the index participants. Self-reported prevention advocacy (on 1-5 scale, with higher scores representing greater engagement in advocacy); scores are averaged across all follow-up assessments
Time frame: Past 6 months as assessed at each follow-up (Months 6, 12, 18)
Population: The Participant Flow included data from all index (PLWH) and alter participants, but this measure was only assessed among index participants. Index participants were included in the analysis if they provided data on the measure in at least one follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- Index | HIV Prevention Advocacy | 3.53 score on a scale | Standard Deviation 0.91 |
| Usual Care Control- Index | HIV Prevention Advocacy | 2.85 score on a scale | Standard Deviation 1.05 |
p-value: <0.001Regression, Linear
Secondary
Internalized HIV Stigma
This outcome is based solely on data from the index participants. Self-reported internalized HIV stigma (on 1-5 scale, with higher scores represented greater stigma); scale score is averaged across all follow-up assessments
Time frame: Reported at each follow-up assessment (Months 6, 12, 18)
Population: The Participant Flow included data from all index (PLWH) and alter participants, but this measure was only assessed among index participants. Index participants were included in the analysis if they provided data on the measure in at least one follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention- Index | Internalized HIV Stigma | 1.62 score on a scale | Standard Deviation 0.72 |
| Usual Care Control- Index | Internalized HIV Stigma | 2.06 score on a scale | Standard Deviation 0.91 |
p-value: <0.001Regression, Linear