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NCT04865341 · ClinicalTrials.gov registry record · NA
Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men
A NA study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- NA
- Development phase
- 118
- Enrollment target
NCT04865341: Completed NA study, sponsored by Medical College of Wisconsin.
NCT04865341 is a NA study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 118 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04865341, a NA study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
Study 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).
Primary Outcome
Self-reported self-administration of HIV testing within the past 3 months (i.e., since baseline assessment).
Interventions
- BEHAVIORAL IMB
- BEHAVIORAL Information-Only Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2024-03-21 |
| Est. Completion | 2024-08-31 |
| Phase | NA |
What the finished NCT04865341 record still lists
NCT04865341 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which IMB is the first listed.
NCT04865341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04865341 about?
NCT04865341 is a clinical study titled "Mobile-health (mHealth) Intervention to Support HIV Self-testing and PrEP Uptake Among Young Men Who Have Sex With Men". 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 prov...
What is the current status of trial NCT04865341?
This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2024-03-21. Estimated completion is 2024-08-31.
What interventions are being tested in trial NCT04865341?
The interventions under investigation include: IMB (BEHAVIORAL), Information-Only Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT04865341?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04865341's enrollment target sits among peer trials
118 803rd of 2000 higher than 1,194 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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