Development of a Tailored HIV Prevention Intervention for Young Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Number of Participants With Change in Number of Risky Sexual Partnerships
研究概览
简要总结
This study uses an interactive design and development process to develop tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies. The study includes a tailored online prevention, intervention, as well as an attention control non--tailored HIV prevention (NTHP) comparison intervention. The pilot RCT will compare the intervention (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and gather preliminary behavioral data to inform a subsequent application. Follow-up assessments will be collected at thirty (30), sixty (60), and ninety (90) days post-intervention.
详细描述
A resurgence of new HIV cases among young men who have sex with men (YMSM; ages 18--24) has underscored the importance of developing culturally- and developmentally- informed HIV programs for YMSM. The investigators are developing and pilot testing a tailored, web- based intervention called myDEx that focuses on delivering HIV prevention messages based on single YMSM's relationship expectations and partner--seeking behaviors. To maximize intervention appeal and appropriateness, the investigators have convened a youth advisory board (YAB) to provide insight and feedback during the 3--stage intervention development process. Using an iterative design and development process, they have developed tailored messages that align YMSM's relationship experiences and desires with HIV prevention strategies. The investigators designed and developed the myDEx tailored online prevention intervention, as well as an attention- control non--tailored HIV/AIDS prevention (NTHP) comparison intervention. After developing both interventions, the investigators used usability testing procedures to collect preliminary data from 16 YMSM on the proposed intervention's design and acceptability. Recommended changes were added to the intervention prior to launching a small pilot randomized controlled trial (RCT). The pilot RCT will compare myDEx (N=120) to NTHP (N=60) to assess intervention feasibility and acceptability, and gather preliminary behavioral data to inform a subsequent application. Assessments will be collected at 30, 60, and 90 days follow--up.
Specific Aims include:
- To develop a tailored (myDEx) and non-tailored (NTHP) HIV prevention intervention focused on addressing HIV risk behaviors among single YMSM;
- To collect preliminary data on the feasibility, acceptability, and intervention content of the myDEx (N=16) in preparation for a small pilot RCT; and,
- To implement a small pilot RCT of the refined myDEx (N=120) as compared to the NTHP (N=60) intervention, in order to evaluate its feasibility and acceptability and gather preliminary efficacy results in reducing sexual risk behaviors.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Cis-gender male
- •Self-report as being single
- •Self report as HIV-negative at baseline
- •Speak and read English
- •Report unprotected anal intercourse with a male partner in prior six (6) months
- •Have access to computer or smartphone device
排除标准
- •Transgender identity
- •HIV positive diagnosis
- •Not residing in the United States
- •Does not engage in male-to-male sexual behavior
研究组 & 干预措施
myDEx Intervention
The proposed intervention will consist of a 6-session web-based program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, YMSM will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help YMSM consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.
干预措施: myDEx (Behavioral)
Non-tailored HIV Prevention
The investigators will create a 6-session web-based attention-control comparison to match myDEx in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites.
干预措施: NTHP (Behavioral)
结局指标
主要结局
Number of Participants With Change in Number of Risky Sexual Partnerships
时间窗: Count of participants from baseline to 90-day follow-up reported
The investigators estimated the change in the total number of participants who reported engaging in condomless anal intercourse from baseline to 90-day follow-up.
Number of Participants With Change in HIV Testing Behavior
时间窗: Count of participants from baseline to 90-day follow-up reported
The investigators estimated the number of participants who reported testing for HIV from baseline to 90-day follow-up.
次要结局
- Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors(Baseline to 90-day follow-up period)
- Changes in Psychological Well-being(Baseline to 90-day follow-up period)
研究者
Jose Bauermeister
Presidential Associate Professor of Nursing
University of Pennsylvania