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Onboarding Positives and PrEP users to Engage Negatives (OPPEN) is an intervention to train young men who have sex with men (YMSM) of color living with HIV or using pre-exposure prophylaxis (PrEP) to promote PrEP use among HIV-negative YMSM of color in their social networks. This pilot randomized controlled trial will evaluate OPPEN's acceptability, feasibility, and preliminary effect on PrEP care engagement among YMSM of color.
Pre-exposure prophylaxis (PrEP) uptake has been slow among young men who have sex with men (YMSM), particularly those of color who experience a high rate of new HIV infections in the United States. Limited PrEP knowledge, unfamiliarity with how to access PrEP, medical mistrust, and stigma are barriers to PrEP care engagement among YMSM, including those of color. Peer-driven social network interventions that train individuals as peer educators to disseminate information about HIV prevention and treatment within their social networks have been implemented to address similar barriers and improve HIV outcomes within hard to reach populations. YMSM of color engaged in HIV/PrEP care often employ resilience processes to overcome socio-structural barriers to HIV prevention and care. As such, training YMSM of color engaged in HIV/PrEP care as peer PrEP educators may position them as credible sources of PrEP information who can influence behavior change (i.e., PrEP care engagement) among YMSM peers of color in their social networks via their ability to disseminate culturally competent PrEP messages in the context of their personal experiences using these resilience processes to navigate the healthcare system, medical mistrust, and stigma. Drawing on existing peer-driven social network interventions, the diffusion of innovations and information-motivation-behavioral skills models, and Harper et al.'s resilience framework, this study will develop and pilot Onboarding Positives and PrEP users to Engage Negatives (OPPEN), a peer-driven PrEP education social network intervention, among YMSM of color in San Diego, California. Through three small-group and two one-on-one sessions, OPPEN will train YMSM of color engaged in HIV/PrEP care to be peer PrEP educators within their social networks. In Phase I, OPPEN was developed, pretested, and refined using an iterative process that integrated feedback elicited from YMSM of color living with HIV and YMSM using PrEP trained via OPPEN as well as HIV-negative YMSM who could benefit from PrEP (AIM 1). In Phase II, OPPEN will be piloted in a randomized controlled trial with 70 YMSM of color engaged in HIV/PrEP care (i.e., indexes; up to two-thirds engaged in PrEP care) randomly assigned to OPPEN (n=35) or a time- and attention-matched control condition (n=35). All indexes will receive coupons to recruit YMSM peers of color within their social networks to the study. Assuming ~2 peers will be recruited per index, ~140 peers will present at the study site (i.e., peer-recruits) and undergo HIV testing. HIV-negative peer-recruits interested in PrEP will be scheduled for a PrEP clinic visit. Data collected via surveys (baseline and 3-month study visits) and medical records will be used to evaluate the preliminary effect of OPPEN on PrEP interest, linkage, and uptake among peer-recruits (AIM 2) and theory-based mechanisms targeted by OPPEN among indexes and peer-recruits (AIM 3). OPPEN acceptability and feasibility will be evaluated using a mixed-methods approach (AIM 4).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPPEN Intervention | Experimental | OPPEN consists of three small-group and two one-on-one sessions to train YMSM of color engaged in HIV or PrEP care to be peer PrEP educators within their social networks. |
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| Control Condition | Other | The time- and attention-matched control condition consists of three small-group and two one-on-one sessions to support diet and nutrition behavior change. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPPEN | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Interest (Peer-Recruit Participants) | 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. | Baseline |
| PrEP Linkage (Peer-Recruit Participants) | Attended a PrEP care visit since baseline. | 3-month follow-up |
| PrEP Uptake (Peer-Recruit Participants) | Started using oral or injectable PrEP since baseline. | 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Conversations With Peers (Index Participants) | Reported having conversations about PrEP with at least one YMSM peer in their social network in the last three months. | 3-month follow-up |
| PrEP Information (Peer-Recruit Participants) |
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Inclusion Criteria (Index Participants):
Inclusion Criteria (Peer-Recruit Participants):
Exclusion Criteria:
Persons screened for eligibility will be asked their gender identity. Those who identify as cisgender men will be eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Heather A Pines, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92103 | United States |
De-identified data will be made available upon review of written requests from researchers.
Approximately 6 months after the publication of the study's primary findings.
Requests from researchers for de-identified data will be reviewed by the research team (Principal Investigator and Co-Investigators).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | OPPEN Peer-Recruit Participants | Peers recruited to participate in the study by index participants randomized to the OPPEN intervention. |
| FG003 | Control Peer-Recruit Participants | Peers recruited to participate in the study by index participants randomized to the control condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | OPPEN Index 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PrEP Interest (Peer-Recruit Participants) | 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. | Posted | Count of Participants | Participants | Baseline |
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We collected adverse event data throughout recruitment and follow-up, spanning ~2.5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OPPEN Index 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Pines | University of California, San Diego | 619-594-2481 | hpines@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2025 | Jul 1, 2025 | Prot_SAP_000.pdf |
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| Control Condition | Behavioral | 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. |
|
Sum score on 13-item PrEP knowledge scale where higher scores indicate greater PrEP knowledge (range: 0-13).
| Baseline |
| PrEP Motivation (Peer-Recruit Participants) | 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). | Baseline |
| PrEP Behavioral Skills (Peer-Recruit Participants) | Sum score on 8-item PrEP self-efficacy scale where higher scores indicate greater PrEP self-efficacy (range: 8-32). | Baseline |
| Session Acceptability (Index Participants) | 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). | 3-month follow-up |
| Session Feasibility (Index Participants) | 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). | 3-month follow-up |
| Acceptability of Interaction With Referring Index (Peer-Recruit Participants) | 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). | Baseline |
| Feasibility of Interaction With Referring Index (Peer-Recruit Participants) | Mean 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). | Baseline |
| Withdrawal by Subject |
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| BG001 | 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. |
| BG002 | OPPEN Peer-Recruit Participants | Peers recruited to participate in the study by index participants randomized to the OPPEN intervention. |
| BG003 | Control Peer-Recruit Participants | Peers recruited to participate in the study by index participants randomized to the control condition. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HIV/PrEP care engagement | Count of Participants | Participants |
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| Primary | PrEP Linkage (Peer-Recruit Participants) | Attended a PrEP care visit since baseline. | Posted | Count of Participants | Participants | 3-month follow-up |
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| Primary | PrEP Uptake (Peer-Recruit Participants) | Started using oral or injectable PrEP since baseline. | Posted | Count of Participants | Participants | 3-month follow-up |
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| Secondary | PrEP Conversations With Peers (Index Participants) | Reported having conversations about PrEP with at least one YMSM peer in their social network in the last three months. | Index participants who completed the study and reported on conversations with YMSM peers in their social networks. | Posted | Count of Participants | Participants | 3-month follow-up |
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| Secondary | PrEP Information (Peer-Recruit Participants) | Sum score on 13-item PrEP knowledge scale where higher scores indicate greater PrEP knowledge (range: 0-13). | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
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| Secondary | PrEP Motivation (Peer-Recruit Participants) | 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). | Peer-Recruit participants who responded to all scale items. | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
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| Secondary | PrEP Behavioral Skills (Peer-Recruit Participants) | Sum score on 8-item PrEP self-efficacy scale where higher scores indicate greater PrEP self-efficacy (range: 8-32). | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
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| Secondary | Session Acceptability (Index Participants) | 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). | Index participants who completed the study and responded to all acceptability items. | Posted | Mean | Standard Deviation | Score on a scale | 3-month follow-up |
|
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| Secondary | Session Feasibility (Index Participants) | 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). | Index participants who completed the study and responded to all feasibility items. | Posted | Mean | Standard Deviation | Score on a scale | 3-month follow-up |
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| Secondary | Acceptability of Interaction With Referring Index (Peer-Recruit Participants) | 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). | Peer-Recruit participants who responded to all acceptability items. | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
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| Secondary | Feasibility of Interaction With Referring Index (Peer-Recruit Participants) | Mean 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). | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
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|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | 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. | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | OPPEN Peer-Recruit Participants | Peers recruited to participate in the study by index participants randomized to the OPPEN intervention. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Control Peer-Recruit Participants | Peers recruited to participate in the study by index participants randomized to the control condition. | 0 | 6 | 0 | 6 | 0 | 6 |
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