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Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services

Westat · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA) · NCT07438041

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 13–24 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
272
US sites recruiting
4
Study start
October 30, 2026
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LYPS; Enhanced Standard of Care

Conditions: HIV; PrEP; PrEP Adherence

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • San Francisco Department of Public Health

    San Francisco, CA 94102

    Site contact: Emily Schaeffer · 628-217-7456 · emily.schaeffer@sfdph.org

  • Emory Atlanta Adolescent Consortium

    Atlanta, GA 30322

    Site contact: Kaylin Dance · (404) 727-5642 · kaylin.dance@emory.edu

  • Johns Hopkins University

    Baltimore, MD 21287

    Site contact: Jessica Coleman · 301-385-4868 · jcolem52@jh.edu

  • Baylor College of Medicine

    Houston, TX 77030

    Site contact: Litty Koshy · 832-822-1038 · Litty.Koshy@bcm.edu

Study contacts (from the official record)

  • Nancy Liu · 718-980-3937 · NancyLiu@westat.com
  • Erin Ricketts · 240-453-2786 · ErinRicketts@westat.com
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Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (NCT07438041) | Bored Studies