NCT07438041 Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
| NCT ID | NCT07438041 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Westat |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 272 participants |
| Start Date | 2026-11-30 |
| Primary Completion | 2028-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 272 participants in total. It began in 2026-11-30 with a primary completion date of 2028-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The LYPS intervention is a multi-level intervention that combines: a) structural-level delivery of PrEP and PrEP services by a community health professional (CHP) at a designated place in the community being offered by the SC where PrEP is not yet provided (e.g., participant's home, community partner location, or traveling mobile van), with b) an individual-level mobile application (app) to support PrEP adherence and persistence between CHP visits.
Eligibility Criteria
Inclusion Criteria: * Age 13-24 years, inclusive; * Reports anal or vaginal sex in the past year; * Is not living with HIV; * Weighs at least 35 kilograms (77 pounds); * Willing to receive PrEP care from a provider at a participating SC either in the clinic or at one of the designated places in the community being offered by the SC SC; * Has an Android-based smartphone or iPhone; * Has fluency in English (able to read, speak, and understand English); and * Willing to provide informed consent to participate in the study. Exclusion Criteria: * Has counter-indications for PrEP according to guidelines and approved local label; * Has any clinically significant systemic disease (including but not limited to significant or uncontrolled liver disease, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis, or bone disease) or diabetes; * Any other medical, behavioral, or other conditions that, in the opinion of the SC project lead or designee, could interfere with adherence to study procedures or compromise interpretation of study results; * Concurrent participation in ATN 166, ATN 170, or any other clinical trial providing HIV medications (PrEP, vaccine, etc.) or currently receiving any PrEP-adherence or persistence behavioral intervention; or * Is currently incarcerated or pending incarceration.
Contact & Investigator
Kate Muessig
STUDY CHAIR
Florida State University
Frequently Asked Questions
Who can join the NCT07438041 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 24 Years, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07438041 currently recruiting?
Yes, NCT07438041 is actively recruiting participants. Contact the research team at NancyLiu@westat.com for enrollment information.
Where is the NCT07438041 trial being conducted?
This trial is being conducted at San Francisco, United States, Atlanta, United States, Baltimore, United States, Houston, United States.
Who is sponsoring the NCT07438041 clinical trial?
NCT07438041 is sponsored by Westat. The principal investigator is Kate Muessig at Florida State University. The trial plans to enroll 272 participants.
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