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

Summary

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).

Conditions

• Human Immunodeficiency Virus

Interventions

BEHAVIORAL

IMB

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.

BEHAVIORAL

Information-Only Control

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).

Sponsors & Collaborators

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Steven A John, MPH, PhD · Medical College of Wisconsin

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

17 Years

Max Age

24 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-21

Primary Completion

2024-08-31

Completion

2024-08-31

Countries

• United States

Study Locations