Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services

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

Interventions

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.

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Florida State University

  collaborator OTHER

• The Emmes Company, LLC

  collaborator INDUSTRY

• Westat

  lead OTHER

Principal Investigators

• Kate Muessig · Florida State University

• Keith Horvath · San Diego State University

• Audrey Pettifor · UNC Chapel Hill

• Lisa Hightow-Weidman, MD, MPH · Florida State University

• Sybil Hosek, PhD · University of Illinois at Chicago

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2028-03-31

Completion

2028-12-31

Countries

• United States

Study Locations