Empowering With PrEP Cluster-Randomized Controlled Trial: A Social Media Based Peer-Led Intervention for HIV Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Number of Participants Intending to Start Using PrEP Over Time
研究概览
简要总结
The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of E-PrEP on reaching young men of color who have sex with men (YMCSM) at high-risk of HIV infection to reduce HIV acquisition. E-PrEP is a peer-designed social media-based health intervention to increase PrEP awareness, knowledge, and motivation as a tool for HIV prevention and to increase linkage to primary care.
详细描述
This study examines a social media based peer-led and delivered intervention focused on increasing PrEP adoption in young men of color who have sex with men (YMCSM). While prior efficacy trials have included YMCSM 18-29, we will focus on PrEP in YMCSM outside clinical trial settings. Rather than an alternative medium for implementation of existing interventions designed for in-person contact, social media may be a true 'game changer' to engage hard to reach individuals. While many online behavioral interventions exist, including some that use social media, this will be one of the few studies to use and test social media to facilitate uptake of a biomedical intervention. E-PrEP will connect the target population (YMCSM) to a new prevention tool (PrEP) through rapid linkage to medical care, accelerating diffusion of PrEP. Given the paucity of data regarding social media-based interventions to change health-related behavior, E-PrEP may have a marked impact on future bio-behavioral interventions, especially those that include diffusion of innovation. Social media offers the power of scale and efficiency for large potential impact, even with relatively low-intensity interventions. Similarly, PrEP, if widely adopted in high-risk populations and offered with behavioral interventions, could markedly decrease HIV infection rates. Social media-based, peer-led approaches like E-PrEP could be used to enhance efforts by community-based and other organizations that employ internet-assisted or peer-outreach strategies to improve health.
Primary Aim: To test the feasibility and preliminary efficacy of E-PrEP for increasing PrEP adoption in a cluster-randomized controlled trial.
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 (Participant, Outcomes Assessor)
盲法说明
Both Peer Leaders and participants will be masked to the group randomized to. The statistician, who will be analyzing the data, will also be masked to group assignment.
入排标准
- 年龄范围
- 18 Years 至 29 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Transgender individual; Ages 18-29; Have had unprotected anal sex with a male partner in the prior 12 months; Fluent in English or Spanish; Are HIV-negative or unknown status (self-report); Identify as Black and/or Latino
排除标准
- •YMCSM who do not consent/assent to study; not currently using at least one of 2 social media sites that will be used for the E-PrEP intervention (not using Facebook, or Instagram), and do not live in New York City.
结局指标
主要结局
Number of Participants Intending to Start Using PrEP Over Time
时间窗: baseline, 6 weeks, and 12 weeks
This primary outcome is intention to use PrEP in the next month measured at baseline, 6 weeks, and 12 weeks. This was assessed with a yes/no question (dichotomous variable). However, this variable does not include anyone who reported PrEP use at either 6 or 12 weeks. This outcome will inform sample size calculations for a subsequent fully powered trial.
Number of Participants Using PrEP Over Time
时间窗: at baseline, 6 weeks, and 12 weeks
This outcome is the number of participants who self-report using PrEP at baseline, 6 weeks, or 12 weeks. This was measure by a yes/no question asking if the participant currently uses PrEP (dichotomous variable).
次要结局
- Self-efficacy About Using PrEP(at baseline, 6 weeks, and 12 weeks)
- PrEP Barriers(baseline, 6 weeks, 12 weeks)
- Communication About PrEP(baseline, 6 weeks, 12 weeks)
- Change in PrEP Knowledge(at baseline, 6 weeks, and 12 weeks)
- PrEP Awareness(baseline, 6 weeks, 12 weeks)
- PrEP Stigma(baseline, 6 weeks, 12 weeks)
研究者
Viraj V. Patel
Assistant Professor
Montefiore Medical Center
