Trial Outcomes & Findings for Onboarding Positives and PrEP Users to Engage Negatives (OPPEN): Peer-driven Education to Link YMSM of Color to PrEP (NCT NCT05356910)
NCT ID: NCT05356910
Last Updated: 2025-07-23
Results Overview
Participants used 5-point Likert scale responses (very uninterested to very interested) to indicate their interest in taking oral PrEP ("How interested are you in taking oral PrEP to prevent HIV?") and injectable PrEP ("How interested are you in taking injectable PrEP to prevent HIV?"). Responses of "interested" or "very interested" in either oral or injectable PrEP defined PrEP interest.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Baseline
Results posted on
2025-07-23
Participant Flow
Participant milestones
| Measure |
OPPEN Index Participants
Index participants randomized to receive the OPPEN intervention, which trains young men who have sex with men (YMSM) of color engaged in HIV or pre-exposure prophylaxis (PrEP) care to be peer PrEP educators within their social networks. OPPEN training sessions (three small-group and two one-on-one sessions) build skills for effective peer PrEP outreach through didactic instruction, group discussions, role-play exercises, and goal planning and problem-solving activities.
|
Control Index Participants
Index participants randomized to receive the time- and attention-matched control condition, which supports diet and nutrition behavior change. Control sessions (three small-group and two one-on-one sessions) build skills for diet and nutrition behavior change through didactic instruction, group discussions, and goal planning and problem-solving activities.
|
OPPEN Peer-Recruit Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
2
|
6
|
|
Overall Study
COMPLETED
|
21
|
14
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
14
|
21
|
0
|
0
|
Reasons for withdrawal
| Measure |
OPPEN Index Participants
Index participants randomized to receive the OPPEN intervention, which trains young men who have sex with men (YMSM) of color engaged in HIV or pre-exposure prophylaxis (PrEP) care to be peer PrEP educators within their social networks. OPPEN training sessions (three small-group and two one-on-one sessions) build skills for effective peer PrEP outreach through didactic instruction, group discussions, role-play exercises, and goal planning and problem-solving activities.
|
Control Index Participants
Index participants randomized to receive the time- and attention-matched control condition, which supports diet and nutrition behavior change. Control sessions (three small-group and two one-on-one sessions) build skills for diet and nutrition behavior change through didactic instruction, group discussions, and goal planning and problem-solving activities.
|
OPPEN Peer-Recruit Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
19
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
0
|
0
|
Baseline Characteristics
Onboarding Positives and PrEP Users to Engage Negatives (OPPEN): Peer-driven Education to Link YMSM of Color to PrEP
Baseline characteristics by cohort
| Measure |
OPPEN Index Participants
n=35 Participants
Index participants randomized to receive the OPPEN intervention, which trains YMSM of color engaged in HIV or PrEP care to be peer PrEP educators within their social networks. OPPEN training sessions (three small-group and two one-on-one sessions) build skills for effective peer PrEP outreach through didactic instruction, group discussions, role-play exercises, and goal planning and problem-solving activities.
|
Control Index Participants
n=35 Participants
Index participants randomized to receive the time- and attention-matched control condition, which supports diet and nutrition behavior change. Control sessions (three small-group and two one-on-one sessions) build skills for diet and nutrition behavior change through didactic instruction, group discussions, and goal planning and problem-solving activities.
|
OPPEN Peer-Recruit Participants
n=2 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=6 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
24.0 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
24.0 years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
26.8 years
STANDARD_DEVIATION 3.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
78 participants
n=21 Participants
|
|
HIV/PrEP care engagement
Engaged in HIV care
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
HIV/PrEP care engagement
Engaged in PrEP care
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
HIV/PrEP care engagement
Not engaged in care
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselineParticipants used 5-point Likert scale responses (very uninterested to very interested) to indicate their interest in taking oral PrEP ("How interested are you in taking oral PrEP to prevent HIV?") and injectable PrEP ("How interested are you in taking injectable PrEP to prevent HIV?"). Responses of "interested" or "very interested" in either oral or injectable PrEP defined PrEP interest.
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=2 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=6 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
PrEP Interest (Peer-Recruit Participants)
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 3-month follow-upAttended a PrEP care visit since baseline.
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=2 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=6 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
PrEP Linkage (Peer-Recruit Participants)
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 3-month follow-upStarted using oral or injectable PrEP since baseline.
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=2 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=6 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
PrEP Uptake (Peer-Recruit Participants)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3-month follow-upPopulation: Index participants who completed the study and reported on conversations with YMSM peers in their social networks.
Reported having conversations about PrEP with at least one YMSM peer in their social network in the last three months.
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=20 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=14 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
PrEP Conversations With Peers (Index Participants)
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: BaselineSum score on 13-item PrEP knowledge scale where higher scores indicate greater PrEP knowledge (range: 0-13).
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=2 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=6 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
PrEP Information (Peer-Recruit Participants)
|
9.0 Score on a scale
Standard Deviation 2.8
|
5.7 Score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: Peer-Recruit participants who responded to all scale items.
Sum of 5-point Likert scale responses (strongly disagree to strongly agree) to scales measuring PrEP attitudes (5 items), PrEP stigma (5 items), subjective PrEP norms (6 items), and descriptive PrEP norms (6 items) where higher scores indicate greater motivation to use PrEP (range: 22-110).
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=2 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=5 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
PrEP Motivation (Peer-Recruit Participants)
|
85.5 Score on a scale
Standard Deviation 9.2
|
77.8 Score on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: BaselineSum score on 8-item PrEP self-efficacy scale where higher scores indicate greater PrEP self-efficacy (range: 8-32).
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=2 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=6 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
PrEP Behavioral Skills (Peer-Recruit Participants)
|
30.5 Score on a scale
Standard Deviation 0.7
|
23.5 Score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 3-month follow-upPopulation: Index participants who completed the study and responded to all acceptability items.
Mean score of 5-point Likert scale responses (strongly disagree to strongly agree) to 21 items measuring acceptability of OPPEN/control sessions among index participants where higher scores indicate greater acceptability (range: 1-5).
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=17 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=14 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
Session Acceptability (Index Participants)
|
4.5 Score on a scale
Standard Deviation 0.4
|
4.3 Score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 3-month follow-upPopulation: Index participants who completed the study and responded to all feasibility items.
Mean score of 5-point Likert scale responses (strongly disagree to strongly agree) to 5 items measuring feasibility of OPPEN/control sessions among index participants where higher scores indicate greater feasibility (range: 1-5).
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=19 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=13 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
Session Feasibility (Index Participants)
|
4.2 Score on a scale
Standard Deviation 0.7
|
3.9 Score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Peer-Recruit participants who responded to all acceptability items.
Mean score of 5-point Likert scale responses (strongly disagree to strongly agree) to 9 items measuring the acceptability of the interaction with their peer (OPPEN or control index) when they referred them to the study among peer-recruit participants where higher scores indicate greater acceptability (range: 1-5).
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=2 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=5 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
Acceptability of Interaction With Referring Index (Peer-Recruit Participants)
|
4.7 Score on a scale
Standard Deviation 0.4
|
3.6 Score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: BaselineMean score of 5-point Likert scale responses (strongly disagree to strongly agree) to 2 items measuring the feasibility of the interaction with their peer (OPPEN or control index) when they referred them to the study among peer-recruit participants where higher scores indicate greater feasibility (range: 1-5).
Outcome measures
| Measure |
OPPEN Peer-Recruit Participants
n=2 Participants
Peers recruited to participate in the study by index participants randomized to the OPPEN intervention.
|
Control Peer-Recruit Participants
n=6 Participants
Peers recruited to participate in the study by index participants randomized to the control condition.
|
|---|---|---|
|
Feasibility of Interaction With Referring Index (Peer-Recruit Participants)
|
4.5 Score on a scale
Standard Deviation 0.7
|
4.0 Score on a scale
Standard Deviation 0.6
|
Adverse Events
OPPEN Index Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Index Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OPPEN Peer-Recruit Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Peer-Recruit Participants
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place