Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS)

Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS): An Innovative Mobile Delivery and Mobile Health (mHealth) Intervention to Optimize PrEP Adherence and Persistence

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PrEP; HIV; PrEP Adherence
• Intervention / Treatment: Other: LYPS; Other: Enhanced Standard of Care

Detailed Description

LYPS is a two-arm randomized controlled trial (RCT) to assess the efficacy of the LYPS intervention. Up to 272 participants will be randomized in a 1:1 ratio to receive either the LYPS intervention or enhanced standard of care (eSOC) (136 participants per arm). The eSOC control condition will consist of usual clinic-based PrEP care and access to a limited number of LYPS app components. Participants will complete four research assessments, at Enrollment and Weeks 12, 24, and 36, that include computer-assisted self-interviews (CASIs) and blood collection. CASIs will collect information including, but not limited to, demographics, PrEP adherence and persistence, PrEP clinic visit attendance, PrEP knowledge and attitudes, PrEP self-efficacy, PrEP stigma, and psychosocial variables, questions that evaluate components of the LYPS intervention, tailored for intervention and eSOC conditions. Blood (dried blood spot [DBS] and plasma) will be collected to evaluate PrEP drug concentrations and stored for additional study-related testing.

All participants will receive daily oral PrEP, oral PrEP taken using a 2-1-1 dosing strategy, or injectable PrEP based on their preference and in consultation with their PrEP provider. There is no randomization involved for PrEP provision and participants are allowed to switch between oral and injectable PrEP or vice versa during the study. PrEP care visits (quarterly for those on oral PrEP and two monthly injections followed by an injection every two months for those on injectable PrEP) will include clinical labs such as HIV and STI testing and focused physical exams for signs and symptoms of HIV infection. Other relevant clinical data collected as part of the participant's PrEP clinical care will also be collected.

• Study Type: Interventional
• Enrollment (Estimated): 272
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Ricketts; Phone Number: 240-453-2786; Email: ErinRicketts@westat.com
• Study Contact Backup: Name: Nancy Liu; Phone Number: 718-980-3937; Email: NancyLiu@westat.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94102
      • San Francisco Department of Public Health
      • Principal Investigator: Albert Liu
      • Contact: Emily Schaeffer; Phone Number: 628-217-7456; Email: emily.schaeffer@sfdph.org
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Atlanta Adolescent Consortium
      • Principal Investigator: Andres Camacho-Gonzalez
      • Contact: Kaylin Dance; Phone Number: (404) 727-5642; Email: kaylin.dance@emory.edu
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
      • Contact: Jessica Coleman; Phone Number: 301-385-4868; Email: jcolem52@jh.edu
      • Principal Investigator: Allison Agwu
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
      • Contact: Litty Koshy; Phone Number: 832-822-1038; Email: Litty.Koshy@bcm.edu
      • Principal Investigator: Mary Paul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: LYPS; 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.
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.	Other: Enhanced Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP adherence at 9 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.	9 months
PrEP persistence at 9 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 9 months.	9 months

Collaborators and Investigators

• Sponsor: Westat
• Collaborators: National Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH); National Institutes of Health (NIH); Florida State University; The Emmes Company, LLC
• Investigators: Principal Investigator: Lisa Hightow-Weidman, MD, MPH, Florida State University; Study Chair: Kate Muessig, Florida State University; Study Chair: Keith Horvath, San Diego State University; Study Chair: Audrey Pettifor, UNC Chapel Hill; Principal Investigator: Sybil Hosek, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Adherence; PrEP; Oral PrEP; Injectable cabotegravir
• Other Study ID Numbers: ATN165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No