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

Completed · Not applicable

Conditions studied: Human Immunodeficiency Virus

In brief

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 facts

Study ID

NCT04865341

Run by

Medical College of Wisconsin

People needed

118

Starts

2024-03-21

Expected to finish

2024-08-31

Last updated by the study team

2026-05-01

Who can join

Age: 17 and older, up to 24. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 17-24 years old;
• Individuals who self-identify as male (including transgender men) and report any male sexual partners in the past 6 months;
• Resident of the US based on home address;
• HIV-negative or unknown status based on self-report; and
• Self-reported risk for HIV (based on CDC criteria for PrEP use) defined as reporting any of the following in the past six months:
• Bacterial STI
• Condomless anal sex (CAS) with a casual male sexual partner
• CAS with an HIV-positive or unknown status main partner
• CAS with an HIV-negative main partner who reports CAS with other male partners.

You may not qualify if…

• Current PrEP use;
• Unstable, serious psychiatric symptoms;
• Currently suicidal/homicidal; and
• Evidence of gross cognitive impairment.

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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