NCT07438041Recruiting
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS): An Innovative Mobile Delivery and Mobile Health (mHealth) Intervention to Optimize PrEP Adherence and Persistence
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 272 (estimated)
- First submitted
- 20 Feb 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 15 Aug 2028
- Lead sponsor
- Westat
- Diseases
- HIV
- NCT number
- NCT07438041
What you commit to
- Study type: Interventional
- Planned participants: 272
- From 30 Oct 2026 to the primary completion date, 15 Aug 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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;
Other
- Has counter-indications for PrEP according to guidelines and approved local label;
- Is currently incarcerated or pending incarceration.
Who the study is looking for
- 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.
Age in the registry: 13 years to 24 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory Atlanta Adolescent Consortium Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| San Francisco Department of Public Health Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.