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临床试验/NCT05356910
NCT05356910已完成不适用

Onboarding Positives and PrEP Users to Engage Negatives (OPPEN): Peer-driven Education to Link YMSM of Color to PrEP

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
PrEP Interest (Peer-Recruit Participants)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •(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

排除标准

  • •Persons who meet the criteria above will be eligible, no other exclusion criteria will apply.

研究组 & 干预措施

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.

干预措施: OPPEN (Behavioral)

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.

干预措施: Control Condition (Behavioral)

结局指标

主要结局

PrEP Interest (Peer-Recruit Participants)

时间窗: 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)

时间窗: 3-month follow-up

Attended a PrEP care visit since baseline.

PrEP Uptake (Peer-Recruit Participants)

时间窗: 3-month follow-up

Started using oral or injectable PrEP since baseline.

次要结局

  • Session Feasibility (Index Participants)(3-month follow-up)
  • PrEP Conversations With Peers (Index Participants)(3-month follow-up)
  • PrEP Information (Peer-Recruit Participants)(Baseline)
  • PrEP Motivation (Peer-Recruit Participants)(Baseline)
  • PrEP Behavioral Skills (Peer-Recruit Participants)(Baseline)
  • Session Acceptability (Index Participants)(3-month follow-up)
  • Acceptability of Interaction With Referring Index (Peer-Recruit Participants)(Baseline)
  • Feasibility of Interaction With Referring Index (Peer-Recruit Participants)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Pines

Associate Professor

University of California, San Diego

研究点 (1)

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