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NCT04865341
IMB-guided Intervention to Encourage PrEP Uptake Among Young Men Who Have Sex With Men
NA trial testing IMB in Human Immunodeficiency Virus in 118 participants. Completed in 31 August 2024.
31 August 2024
Quick facts
| Lead sponsor | Medical College of Wisconsin |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 118 |
| Start date | 21 March 2024 |
| Primary completion | 31 August 2024 |
| Estimated completion | 31 August 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- IMB
- Information-Only Control
Conditions studied
- Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
Sponsor
Medical College of Wisconsin
Who can join
Adults 17 to 24, male only, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 in each study. 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 professionally produced videos 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 brief single-session intervention (45-60 minutes). Intervention content is subject to change depending on feedback from focus groups, survey results, YAB 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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04865341
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Human Immunodeficiency Virus
Currently open trials in the same condition.
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- NCT06408142 — Universal Test and Connect for HIV Service Delivery in South Africa · recruiting
- NCT07101458 — The Eswatini PRISM Study on Adolescents Living With HIV · NA · recruiting
- NCT06554223 — The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care · NA · recruiting
Other Medical College of Wisconsin trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04865341 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
- Last refreshed: 11 December 2024
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