- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02842060
Development of a Tailored HIV Prevention Intervention for Young Men (myDEx)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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myDEx will consist of a 6-session online 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, participants 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 men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.
|
Active Comparator: 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.
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The investigators will create a 6-session attention-control comparison to match the intervention 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.
The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV.
Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Change in Number of Risky Sexual Partnerships
Time Frame: Count of participants from baseline to 90-day follow-up reported
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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.
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Count of participants from baseline to 90-day follow-up reported
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Number of Participants With Change in HIV Testing Behavior
Time Frame: Count of participants from baseline to 90-day follow-up reported
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The investigators estimated the number of participants who reported testing for HIV from baseline to 90-day follow-up.
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Count of participants from baseline to 90-day follow-up reported
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors
Time Frame: Baseline to 90-day follow-up period
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The investigators will measure the change in safer sex self-efficacy over time using the HIV Risk Behavior Self-Efficacy Scale by Fisher, Fisher, Misovich, Kimble & Malloy (1996).
The scale is measured on a 4-point scale (range 1-4), where higher scores mean less self-efficacy to negotiate safer sex with partners met online.
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Baseline to 90-day follow-up period
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Changes in Psychological Well-being
Time Frame: Baseline to 90-day follow-up period
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The investigators will measure symptoms of depression and anxiety using the Brief Symptom Inventory by Derogatis & Spencer (1982).
Higher mean scores (scale 1-4) indicate greater symptoms of psychological distress.
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Baseline to 90-day follow-up period
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jose A Bauermeister, PhD, University of Pennsylvania
Publications and helpful links
General Publications
- Choi SK, Golinkoff J, Michna M, Connochie D, Bauermeister J. Correlates of Engagement Within an Online HIV Prevention Intervention for Single Young Men Who Have Sex With Men: Randomized Controlled Trial. JMIR Public Health Surveill. 2022 Jun 27;8(6):e33867. doi: 10.2196/33867.
- Connochie D, Tingler RC, Bauermeister JA. Young men who have sex with men's awareness, acceptability, and willingness to participate in HIV vaccine trials: Results from a nationwide online pilot study. Vaccine. 2019 Oct 8;37(43):6494-6499. doi: 10.1016/j.vaccine.2019.08.076. Epub 2019 Sep 13.
- Bauermeister JA, Tingler RC, Demers M, Harper GW. Development of a Tailored HIV Prevention Intervention for Single Young Men Who Have Sex With Men Who Meet Partners Online: Protocol for the myDEx Project. JMIR Res Protoc. 2017 Jul 19;6(7):e141. doi: 10.2196/resprot.7965.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH101997 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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