Development of a Tailored HIV Prevention Intervention for Young Men
myDEx
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Nov 2016
Shorter than P25 for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
July 16, 2019
CompletedJuly 16, 2019
June 1, 2019
6 months
July 16, 2016
February 25, 2019
June 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Change in Number of Risky Sexual Partnerships
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.
Count of participants from baseline to 90-day follow-up reported
Number of Participants With Change in HIV Testing Behavior
The investigators estimated the number of participants who reported testing for HIV from baseline to 90-day follow-up.
Count of participants from baseline to 90-day follow-up reported
Secondary Outcomes (2)
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
Study Arms (2)
myDEx Intervention
EXPERIMENTALThe 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.
Non-tailored HIV Prevention
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Transgender identity
- HIV positive diagnosis
- Not residing in the United States
- Does not engage in male-to-male sexual behavior
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- University of Michigancollaborator
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (3)
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.
PMID: 35759333DERIVEDConnochie 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.
PMID: 31522806DERIVEDBauermeister 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.
PMID: 28724513DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We did not include biological confirmation of HIV/STI status through serologic tests, as this pilot trial did not seek to detect statistical differences in outcomes. HIV testing will be included in a full-scale efficacy trial.
Results Point of Contact
- Title
- Dr. Jose Bauermeister
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Jose A Bauermeister, PhD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Presidential Associate Professor of Nursing
Study Record Dates
First Submitted
July 16, 2016
First Posted
July 22, 2016
Study Start
November 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
July 16, 2019
Results First Posted
July 16, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.