Recruiting

PrEP with App

Sponsor:

Westat

Code:

NCT07438041

Conditions

HIV

PrEP

PrEP Adherence

Eligibility Criteria

Sex: All

Age: 13 - 24

Healthy Volunteers: Accepted

Interventions

LYPS

Enhanced Standard of Care

Study Details

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

Study ID

NCT07438041

Start date

Oct 15, 2026

Status verified date

Oct, 2026

Completion date

Dec 15, 2028

Anticipated

Primary completion date

Aug 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 24

Healthy Volunteers: Accepted

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 Design

Enrollment

272 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nancy Liu

718-980-3937NancyLiu@westat.com

Erin Ricketts

240-453-2786ErinRicketts@westat.com

Locations

San Francisco Department of Public Health

Recruiting

San Francisco, California, United States, 94102

Contacts

Emily Schaeffer

628-217-7456emily.schaeffer@sfdph.org

Principal Investigator:

Albert Liu

Emory Atlanta Adolescent Consortium

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kaylin Dance

(404) 727-5642kaylin.dance@emory.edu

Principal Investigator:

Andres Camacho-Gonzalez

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jessica Coleman

301-385-4868jcolem52@jh.edu

Principal Investigator:

Allison Agwu

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Litty Koshy

832-822-1038Litty.Koshy@bcm.edu

Principal Investigator:

Mary Paul

More Information

Sponsor

Westat

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • PrEP
  • Adherence
  • Oral PrEP
  • Injectable cabotegravir

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Westat on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.