NCT07438041 · Westat
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
(LYPS)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
PrEP adherence at 6 months
Time frame: 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.
PrEP persistence at 6 months
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- San Francisco, California
- Atlanta, Georgia
- Baltimore, Maryland
- Houston, Texas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Florida State University, The Emmes Company, LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations