Development of a Tailored HIV Prevention Intervention for Young Men
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Number of Participants With Change in HIV Testing Behavior
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 24 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Transgender identity
- •HIV positive diagnosis
- •Not residing in the United States
- •Does not engage in male-to-male sexual behavior
Arms & Interventions
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.
Intervention: NTHP (Behavioral)
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.
Intervention: myDEx (Behavioral)
Outcomes
Primary Outcomes
Number of Participants With Change in HIV Testing Behavior
Time Frame: 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.
Number of Participants With Change in Number of Risky Sexual Partnerships
Time Frame: 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.
Secondary Outcomes
- Changes in Psychological Well-being(Baseline to 90-day follow-up period)
- Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors(Baseline to 90-day follow-up period)
Investigators
Jose Bauermeister
Presidential Associate Professor of Nursing
University of Pennsylvania