Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men
Public ClinicalTrials.gov record NCT04865341. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Optimizing an IMB-guided Intervention to Support HIV Self-testing and PrEP Uptake Among YMSM: A Pilot Randomized Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04865341
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 118 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 17 Years to 24 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 20, 2024
- Primary completion
- Aug 30, 2024
- Completion
- Aug 30, 2024
- Last update posted
- Apr 30, 2026
2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04865341, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04865341 live on ClinicalTrials.gov.