HIV
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALOPPEN
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.
BEHAVIORALControl Condition
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.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
(Index Participants): * 18-34 years-old * Cisgender male * Fluent in English * Person of color * Engaged in HIV care or PrEP care * Sexual activity with cisgender men or transgender women in their lifetime * Social networks with at least three 18-34 year-old MSM peers of color * Willing to disclose their HIV status or PrEP use to their 18-34 year-old MSM peers of color * Willing to provide written informed consent Inclusion Criteria (Peer-Recruit Participants): * 18-34 years-old * Cisgender male * Fluent in English or Spanish * Person of color * HIV-negative * Not using PrEP * Sexual activity with cisgender men or transgender women in their lifetime * Willing to provide written informed consent
Exclusion criteria
* Persons who meet the criteria above will be eligible, no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Interest (Peer-Recruit Participants) | Baseline | 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. |
| PrEP Linkage (Peer-Recruit Participants) | 3-month follow-up | Attended a PrEP care visit since baseline. |
| PrEP Uptake (Peer-Recruit Participants) | 3-month follow-up | Started using oral or injectable PrEP since baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Behavioral Skills (Peer-Recruit Participants) | Baseline | Sum score on 8-item PrEP self-efficacy scale where higher scores indicate greater PrEP self-efficacy (range: 8-32). |
| Session Acceptability (Index Participants) | 3-month follow-up | 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). |
| PrEP Conversations With Peers (Index Participants) | 3-month follow-up | Reported having conversations about PrEP with at least one YMSM peer in their social network in the last three months. |
| Acceptability of Interaction With Referring Index (Peer-Recruit Participants) | Baseline | 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). |
| Feasibility of Interaction With Referring Index (Peer-Recruit Participants) | Baseline | 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). |
| Session Feasibility (Index Participants) | 3-month follow-up | 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). |
| PrEP Information (Peer-Recruit Participants) | Baseline | Sum score on 13-item PrEP knowledge scale where higher scores indicate greater PrEP knowledge (range: 0-13). |
| PrEP Motivation (Peer-Recruit Participants) | Baseline | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 35 |
| OPPEN Peer-Recruit Participants Peers recruited to participate in the study by index participants randomized to the OPPEN intervention. | 2 |
| Control Peer-Recruit Participants Peers recruited to participate in the study by index participants randomized to the control condition. | 6 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 19 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | OPPEN Index Participants | Control Index Participants | OPPEN Peer-Recruit Participants | Control Peer-Recruit Participants | Total |
|---|---|---|---|---|---|
| Age, Continuous | 27.3 years STANDARD_DEVIATION 3.5 | 26.9 years STANDARD_DEVIATION 4.3 | 24.0 years STANDARD_DEVIATION 1.4 | 24.0 years STANDARD_DEVIATION 3 | 26.8 years STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 28 Participants | 1 Participants | 6 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 7 Participants | 1 Participants | 0 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| HIV/PrEP care engagement Engaged in HIV care | 11 Participants | 12 Participants | 0 Participants | 0 Participants | 23 Participants |
| HIV/PrEP care engagement Engaged in PrEP care | 24 Participants | 23 Participants | 0 Participants | 0 Participants | 47 Participants |
| HIV/PrEP care engagement Not engaged in care | 0 Participants | 0 Participants | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 7 Participants | 1 Participants | 1 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 2 Participants | 1 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 13 Participants | 0 Participants | 2 Participants | 25 Participants |
| Race (NIH/OMB) White | 8 Participants | 12 Participants | 0 Participants | 1 Participants | 21 Participants |
| Region of Enrollment United States | 35 participants | 35 participants | 2 participants | 6 participants | 78 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 35 Participants | 35 Participants | 2 Participants | 6 Participants | 78 Participants |
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 | 0 / 35 | 0 / 35 | 0 / 2 | 0 / 6 |
| other Total, other adverse events | 0 / 35 | 0 / 35 | 0 / 2 | 0 / 6 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 | 0 / 2 | 0 / 6 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPPEN Peer-Recruit Participants | PrEP Interest (Peer-Recruit Participants) | 2 Participants |
| Control Peer-Recruit Participants | PrEP Interest (Peer-Recruit Participants) | 3 Participants |
Primary
PrEP Linkage (Peer-Recruit Participants)
Attended a PrEP care visit since baseline.
Time frame: 3-month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPPEN Peer-Recruit Participants | PrEP Linkage (Peer-Recruit Participants) | 1 Participants |
| Control Peer-Recruit Participants | PrEP Linkage (Peer-Recruit Participants) | 2 Participants |
Primary
PrEP Uptake (Peer-Recruit Participants)
Started using oral or injectable PrEP since baseline.
Time frame: 3-month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPPEN Peer-Recruit Participants | PrEP Uptake (Peer-Recruit Participants) | 1 Participants |
| Control Peer-Recruit Participants | PrEP Uptake (Peer-Recruit Participants) | 2 Participants |
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).
Time frame: Baseline
Population: Peer-Recruit participants who responded to all acceptability items.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPPEN Peer-Recruit Participants | Acceptability of Interaction With Referring Index (Peer-Recruit Participants) | 4.7 Score on a scale | Standard Deviation 0.4 |
| Control Peer-Recruit Participants | Acceptability of Interaction With Referring Index (Peer-Recruit Participants) | 3.6 Score on a scale | Standard Deviation 0.8 |
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPPEN Peer-Recruit Participants | Feasibility of Interaction With Referring Index (Peer-Recruit Participants) | 4.5 Score on a scale | Standard Deviation 0.7 |
| Control Peer-Recruit Participants | Feasibility of Interaction With Referring Index (Peer-Recruit Participants) | 4.0 Score on a scale | Standard Deviation 0.6 |
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPPEN Peer-Recruit Participants | PrEP Behavioral Skills (Peer-Recruit Participants) | 30.5 Score on a scale | Standard Deviation 0.7 |
| Control Peer-Recruit Participants | PrEP Behavioral Skills (Peer-Recruit Participants) | 23.5 Score on a scale | Standard Deviation 5.8 |
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.
Time frame: 3-month follow-up
Population: Index participants who completed the study and reported on conversations with YMSM peers in their social networks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| OPPEN Peer-Recruit Participants | PrEP Conversations With Peers (Index Participants) | 15 Participants |
| Control Peer-Recruit Participants | PrEP Conversations With Peers (Index Participants) | 9 Participants |
Secondary
PrEP Information (Peer-Recruit Participants)
Sum score on 13-item PrEP knowledge scale where higher scores indicate greater PrEP knowledge (range: 0-13).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPPEN Peer-Recruit Participants | PrEP Information (Peer-Recruit Participants) | 9.0 Score on a scale | Standard Deviation 2.8 |
| Control Peer-Recruit Participants | PrEP Information (Peer-Recruit Participants) | 5.7 Score on a scale | Standard Deviation 2.9 |
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).
Time frame: Baseline
Population: Peer-Recruit participants who responded to all scale items.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPPEN Peer-Recruit Participants | PrEP Motivation (Peer-Recruit Participants) | 85.5 Score on a scale | Standard Deviation 9.2 |
| Control Peer-Recruit Participants | PrEP Motivation (Peer-Recruit Participants) | 77.8 Score on a scale | Standard Deviation 13.9 |
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).
Time frame: 3-month follow-up
Population: Index participants who completed the study and responded to all acceptability items.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPPEN Peer-Recruit Participants | Session Acceptability (Index Participants) | 4.5 Score on a scale | Standard Deviation 0.4 |
| Control Peer-Recruit Participants | Session Acceptability (Index Participants) | 4.3 Score on a scale | Standard Deviation 0.4 |
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).
Time frame: 3-month follow-up
Population: Index participants who completed the study and responded to all feasibility items.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPPEN Peer-Recruit Participants | Session Feasibility (Index Participants) | 4.2 Score on a scale | Standard Deviation 0.7 |
| Control Peer-Recruit Participants | Session Feasibility (Index Participants) | 3.9 Score on a scale | Standard Deviation 0.5 |