Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services

Part of paid clinical trials in San Francisco, California.

Sponsor
Westat
Study ID
NCT07438041
Status
Not Yet Recruiting

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Conditions

  • HIV
  • PrEP
  • PrEP Adherence

Eligibility Criteria

Sex
ALL
Age
13 Years - 24 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
272 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: LYPS Intervention
    PrEP and PrEP care will be delivered to youth in the communities where they live through a Community Health Professional (CHP) (e.g., a nurse or other qualified health care professional home, friend's home, community venue or clinic, mobile health clinic), supplemented by a mobile app to provide real-time intervention between CHP visits.
  • Active Comparator: Enhanced Standard of Care (eSOC) Control Condition
    Usual standard of care clinic-based PrEP, enhanced with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders.

Primary Outcome Measure

PrEP adherence at 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
San Francisco Department of Public HealthSan FranciscoCalifornia94102
Emily Schaeffer
[email protected]
628-217-7456
Albert Liu (PRINCIPAL_INVESTIGATOR)
Emory Atlanta Adolescent ConsortiumAtlantaGeorgia30322
Kaylin Dance
[email protected]
(404) 727-5642
Andres Camacho-Gonzalez (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Jessica Coleman
[email protected]
301-385-4868
Allison Agwu (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Litty Koshy
[email protected]
832-822-1038
Mary Paul (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
HIV
By specialty
Infectious disease
By research site
San Francisco Department of Public Health· San Francisco, CAEmory Atlanta Adolescent Consortium· Atlanta, GAJohns Hopkins University· Baltimore, MDBaylor College of Medicine· Houston, TX

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