Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services

NCT07438041 | Not Yet Recruiting DMC

• 1 other identifier: ATN165
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV; PrEP; PrEP Adherence

Keywords

PrEP; Adherence; Oral PrEP; Injectable cabotegravir

Outcome Measures

Primary Outcomes (2)

• PrEP adherence at 6 months

  Determine adherence outcomes as measured by blood will be tailored for oral PrEP modality (daily oral or 2-1-1) and target vs. non-target PrEP concentration thresholds (depending on regimen) will be examined. Adherence outcomes for participants on injectable PrEP will be determined by the timely (± 1 week for the second injection; ± 2 weeks for any subsequent injection) administration of injections.

  6 months

• PrEP persistence at 6 months

  Access persistence measures as based on 1) participant's self-report of currently taking PrEP (daily or 2-1-1) or having received last shot of injectable PrEP, and 2) has an active prescription for PrEP based on study records or drug level associated with use at 6 months.

  6 months

Secondary Outcomes (2)

• PrEP adherence at 9 months

  9 months

• PrEP persistence at 9 months

  9 months

Study Arms (2)

LYPS Intervention

EXPERIMENTAL

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.

Other: LYPS

Enhanced Standard of Care (eSOC) Control Condition

ACTIVE COMPARATOR

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.

Other: Enhanced Standard of Care

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.

LYPS Intervention

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.

Enhanced Standard of Care (eSOC) Control Condition

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Westat: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institutes of Health (NIH): collaborator
• Florida State University: collaborator
• The Emmes Company, LLC: collaborator

Study Sites (4)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Emory Atlanta Adolescent Consortium

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Officials

• Kate Muessig

  Florida State University

  STUDY CHAIR

• Keith Horvath

  San Diego State University

  STUDY CHAIR

• Audrey Pettifor

  UNC Chapel Hill

  STUDY CHAIR

• Lisa Hightow-Weidman, MD, MPH

  Florida State University

  PRINCIPAL INVESTIGATOR

• Sybil Hosek, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Liu

CONTACT

718-980-3937; NancyLiu@westat.com

Erin Ricketts

CONTACT

240-453-2786; ErinRicketts@westat.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive either the LYPS intervention or eSOC. The LYPS intervention arm consists of 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 an individual-level mobile application to support PrEP adherence and persistence between CHP visits. The eSOC control condition consists of usual clinic-based PrEP care and access to a limited number of LYPS app components.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)