Development of a Tailored HIV Prevention Intervention for Young Men (myDEx)

• ClinicalTrials.gov Identifier: NCT02842060
• Recruitment Status: Completed
• First Posted: July 22, 2016
• Results First Posted: July 16, 2019
• Last Update Posted: July 16, 2019
• Sponsor: University of Pennsylvania
• Collaborator: University of Michigan
• Information provided by (Responsible Party): Jose Bauermeister, University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Behavioral: myDEx; Behavioral: NTHP	Not Applicable

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:

1. To develop a tailored (myDEx) and non-tailored (NTHP) HIV prevention intervention focused on addressing HIV risk behaviors among single YMSM;
2. To collect preliminary data on the feasibility, acceptability, and intervention content of the myDEx (N=16) in preparation for a small pilot RCT; and,
3. 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 (Clinical Trial)
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Development of a Tailored HIV Prevention Intervention for Young Men
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: May 2017
• Actual Study Completion Date: May 2017

Arms and Interventions

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.	Behavioral: myDEx; 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.	Behavioral: NTHP; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors [ Time Frame: Baseline to 90-day follow-up period ]
   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.
2. Changes in Psychological Well-being [ Time Frame: Baseline to 90-day follow-up period ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 24 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

University of Michigan

Investigators

• Principal Investigator: Jose A Bauermeister, PhD; University of Pennsylvania

  Study Documents (Full-Text)

Documents provided by Jose Bauermeister, University of Pennsylvania:

Study Protocol and Statistical Analysis Plan  [PDF] May 20, 2019

Informed Consent Form  [PDF] October 11, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jose Bauermeister, Presidential Associate Professor of Nursing, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02842060
• Other Study ID Numbers: R34MH101997 ( U.S. NIH Grant/Contract )
• First Posted: July 22, 2016
• Results First Posted: July 16, 2019
• Last Update Posted: July 16, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.

Keywords provided by Jose Bauermeister, University of Pennsylvania:

Prevention & Control; Young Adult; Internet

Additional relevant MeSH terms:

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases