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NCT04865341Completed

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

Optimizing an IMB-guided Intervention to Support HIV Self-testing and PrEP Uptake Among YMSM: A Pilot Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Interventional
Enrollment
118 (actual)
First submitted
26 Apr 2021
Start date
21 Mar 2024
Primary completion date
31 Aug 2024
Lead sponsor
Medical College of Wisconsin
Diseases
HIV
NCT number
NCT04865341

What you commit to

  • Study type: Interventional
  • Participants enrolled: 118
  • From 21 Mar 2024 to the primary completion date, 31 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Unstable, serious psychiatric symptoms;
  • Evidence of gross cognitive impairment.

Other

  • Current PrEP use;
  • Currently suicidal/homicidal; and

Who the study is looking for

  • 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.

Age in the registry: 17 years to 24 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.