Trial Outcomes & Findings for Randomized Controlled Trial of Game Changers (NCT NCT05098015)
NCT ID: NCT05098015
Last Updated: 2026-01-15
Results Overview
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.
COMPLETED
NA
809 participants
Data regarding HIV testing over the past 6 months, assessed at each follow-up assessment (Months 6, 12, 18)
2026-01-15
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Usual Care Control- Index
Participants will receive HIV usual care, and no added intervention.
|
Intervention- Alter
Alter participants recruited by enrolled index participants assigned to receive the intervention comprise this group; however, these alter participants did not receive any intervention
|
Usual Care Control- Alter
Alter participants recruited by enrolled index participants assigned to the usual care control group comprise this arm
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
105
|
105
|
324
|
275
|
|
Overall Study
COMPLETED
|
103
|
102
|
318
|
270
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
6
|
5
|
Reasons for withdrawal
| Measure |
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.
|
Usual Care Control- Index
Participants will receive HIV usual care, and no added intervention.
|
Intervention- Alter
Alter participants recruited by enrolled index participants assigned to receive the intervention comprise this group; however, these alter participants did not receive any intervention
|
Usual Care Control- Alter
Alter participants recruited by enrolled index participants assigned to the usual care control group comprise this arm
|
|---|---|---|---|---|
|
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
This measure was only assessed among index participants (in both the intervention-index and usual care control-index arms), all of whom were persons living with HIV
Baseline characteristics by cohort
| Measure |
Intervention- Index
n=105 Participants
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.
|
Usual Care Control- Index
n=105 Participants
Participants will receive HIV usual care, and no added intervention.
|
Usual Care Control- Alter
n=275 Participants
Alter participants recruited by enrolled index participants assigned to the usual care control group
|
Intervention- Alter
n=324 Participants
Alter participants recruited by enrolled index participants assigned to the intervention group; however, these alter participants did not receive any intervention
|
Total
n=809 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=105 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=275 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=809 Participants
|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 10.7 • n=105 Participants
|
39.3 years
STANDARD_DEVIATION 10.5 • n=105 Participants
|
38.2 years
STANDARD_DEVIATION 12.4 • n=275 Participants
|
36.6 years
STANDARD_DEVIATION 12.3 • n=324 Participants
|
38.0 years
STANDARD_DEVIATION 12.0 • n=809 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=105 Participants
|
73 Participants
n=105 Participants
|
174 Participants
n=275 Participants
|
223 Participants
n=324 Participants
|
544 Participants
n=809 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=105 Participants
|
32 Participants
n=105 Participants
|
101 Participants
n=275 Participants
|
101 Participants
n=324 Participants
|
265 Participants
n=809 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=105 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=275 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=809 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=105 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=275 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=809 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=105 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=275 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=809 Participants
|
|
Race (NIH/OMB)
Black or African American
|
105 Participants
n=105 Participants
|
105 Participants
n=105 Participants
|
275 Participants
n=275 Participants
|
324 Participants
n=324 Participants
|
809 Participants
n=809 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=105 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=275 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=809 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=105 Participants
|
0 Participants
n=105 Participants
|
0 Participants
n=275 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=809 Participants
|
|
Time since HIV diagnosis
|
10.8 years
STANDARD_DEVIATION 6.1 • n=105 Participants • This measure was only assessed among index participants (in both the intervention-index and usual care control-index arms), all of whom were persons living with HIV
|
11.1 years
STANDARD_DEVIATION 5.2 • n=105 Participants • This measure was only assessed among index participants (in both the intervention-index and usual care control-index arms), all of whom were persons living with HIV
|
—
|
—
|
11.0 years
STANDARD_DEVIATION 5.6 • n=210 Participants • This measure was only assessed among index participants (in both the intervention-index and usual care control-index arms), all of whom were persons living with HIV
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention- Index
n=91 Participants
8-session group intervention to train 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.
|
Usual Care Control- Index
n=78 Participants
Participants will receive HIV usual care, and no added intervention.
|
|---|---|---|
|
HIV Testing
|
71.60 percentage of alters
Standard Deviation 35.23
|
71.61 percentage of alters
Standard Deviation 37.19
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention- Index
n=92 Participants
8-session group intervention to train 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.
|
Usual Care Control- Index
n=88 Participants
Participants will receive HIV usual care, and no added intervention.
|
|---|---|---|
|
Condom Use
|
18.04 percentage of alters
Standard Deviation 29.60
|
13.15 percentage of alters
Standard Deviation 27.06
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Intervention- Index
n=105 Participants
8-session group intervention to train 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.
|
Usual Care Control- Index
n=104 Participants
Participants will receive HIV usual care, and no added intervention.
|
|---|---|---|
|
Internalized HIV Stigma
|
1.62 score on a scale
Standard Deviation 0.72
|
2.06 score on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Intervention- Index
n=105 Participants
8-session group intervention to train 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.
|
Usual Care Control- Index
n=104 Participants
Participants will receive HIV usual care, and no added intervention.
|
|---|---|---|
|
HIV Prevention Advocacy
|
3.53 score on a scale
Standard Deviation 0.91
|
2.85 score on a scale
Standard Deviation 1.05
|
Adverse Events
Intervention- Index
Usual Care Control- Index
Usual Care Control- Alter
Intervention- Alter
Serious adverse events
| Measure |
Intervention- Index
n=105 participants at risk
8-session group intervention to train 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.
|
Usual Care Control- Index
n=105 participants at risk
Participants will receive HIV usual care, and no added intervention.
|
Usual Care Control- Alter
n=275 participants at risk
Alter participants recruited by index participants assigned to the usual care control group comprise this arm
|
Intervention- Alter
n=324 participants at risk
Alter participants recruited by index participants assigned to the intervention group comprise this arm; however, these alter participants did not receive an intervention
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
domestic violence
|
0.95%
1/105 • Number of events 1 • Each participant was assessed over 18 months from enrollment.
Adverse events were assessed for all index (PLWH) and alter participants.
|
0.00%
0/105 • Each participant was assessed over 18 months from enrollment.
Adverse events were assessed for all index (PLWH) and alter participants.
|
0.00%
0/275 • Each participant was assessed over 18 months from enrollment.
Adverse events were assessed for all index (PLWH) and alter participants.
|
0.00%
0/324 • Each participant was assessed over 18 months from enrollment.
Adverse events were assessed for all index (PLWH) and alter participants.
|
|
Social circumstances
loss of job
|
0.95%
1/105 • Number of events 1 • Each participant was assessed over 18 months from enrollment.
Adverse events were assessed for all index (PLWH) and alter participants.
|
0.00%
0/105 • Each participant was assessed over 18 months from enrollment.
Adverse events were assessed for all index (PLWH) and alter participants.
|
0.00%
0/275 • Each participant was assessed over 18 months from enrollment.
Adverse events were assessed for all index (PLWH) and alter participants.
|
0.00%
0/324 • Each participant was assessed over 18 months from enrollment.
Adverse events were assessed for all index (PLWH) and alter participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place