RECRUITING Not applicable ClinicalTrials.gov

Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services

Sponsor: Westat • ClinicalTrials.gov ID: NCT07438041

Registry updated: 2026-10-16

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Description

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.

Interventions

LYPS (Other)
The LYPS intervention combines the use of a CHP to deliver PrEP services 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 an android-based smartphone or iphone app to support PrEP use between CHP visits.
Enhanced Standard of Care (Other)
Clinic-based PrEP services per usual standard of care (e.g., HIV and STI testing, clinical assessments for signs and symptoms of HIV and PrEP safety) with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders.

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.

Conditions

HIV PrEP PrEP Adherence

Locations

San Francisco Department of Public Health — San Francisco, California, United States
Emory Atlanta Adolescent Consortium — Atlanta, Georgia, United States
Johns Hopkins University — Baltimore, Maryland, United States
Baylor College of Medicine — Houston, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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