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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 is a NA study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 118 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04865341
The ClinicalTrials.gov registry entry for NCT04865341 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IMB is the first listed.
NCT04865341 reports 0 study locations.
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.
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