Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT04865341
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
17 Years - 24 Years
Healthy Volunteers
Accepted

Interventions

  • IMB — BEHAVIORAL
    Intervention content will be focused on the Information-Motivation-Behavioral Skills (IMB) model. We plan to incorporate previously developed content as much as possible and will include content about HIV testing and PrEP and other resources. We believe our approach of guiding YMSM through intervention modules based on theory will help improve content retention/use and ultimately influence constructs posited to result in behavior change. We foresee using multiple forms of attention-matched material, media, and programming to engage (and retain engagement) of YMSM throughout the intervention.
  • Information-Only Control — BEHAVIORAL
    Intervention content will be focused on the information construct of the Information-Motivation-Behavioral Skills (IMB) model. We plan to incorporate previously developed content as much as possible and will include professionally produced videos about HIV testing and PrEP and other resources. We believe our approach of guiding YMSM through intervention modules based on theory will help improve content retention/use and ultimately influence constructs posited to result in behavior change. We foresee using multiple forms of attention-matched material, media, and programming to engage (and retain engagement) of YMSM throughout the brief single-session intervention (45-60 minutes).

Study Details

The proposed study will involve adolescent (17-24 years old) men who have sex with men (described as YMSM hereafter) who meet eligibility criteria to participate. Prospective study candidates will receive a copy of the IRB-approved informed consent forms and, if they choose to participate, will provide consent before enrollment into this study. Involvement of human subjects is detailed in the Research Strategy portion of this proposal, Recruitment and Retention Plan, and Protection of Human Subjects sections. Briefly, investigators will develop and pilot a randomized controlled trial (RCT) to support HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP) uptake. Intervention content will be focused on constructs of the Information-Motivation-Behavioral Skills (IMB) model. To reduce cost and increase feasibility, investigators plan to incorporate previously developed content as much as possible-investigators see integration of this content as a major strength. Investigators will include content about HIV testing and PrEP and other resources including the geo-targeted directories to find clinic settings that offer HIV testing and PrEP, all of which are publicly available. Investigators believe our approach of guiding YMSM through intervention modules based on theory will help improve content retention/use and ultimately influence constructs posited to result in behavior change. Investigators foresee using multiple forms of attention-matched material, media, and programming to engage (and retain engagement) of YMSM throughout the intervention. Intervention content was developed on feedback from focus groups, survey results, youth advisory board feedback, and usability testing. Primary endpoints of this study include HIVST and PrEP uptake, including stage of change towards HIVST and PrEP uptake. Secondary outcomes include changes in IMB model indicators (e.g., HIV prevention knowledge).

Key Dates

Start date
Mar 21, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
118 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: IMB
    Individuals randomized to this arm will receive a behavioral intervention based on the Information-Motivation-Behavior (IMB) model designed to increase HIV self-testing, among other protective behaviors.
  • Other: Information-Only Control
    Attention-matched comparison condition (information-only)

Primary Outcome Measure

Number of Participants With Self-reported Self-administration of HIV Testing [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Milwaukee, WI

By condition
HIV
By specialty
Infectious disease
By research site
Medical College of Wisconsin· Milwaukee, WI

Related Studies