Linking Youth to PrEP Services for HIV Prevention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial will enroll up to 272 participants aged 13–24 who are at risk for HIV and not living with HIV. Participants are assigned to LYPS, a multi-level intervention with community-based PrEP delivery plus a mobile app to support adherence, or to enhanced standard of care with usual clinic PrEP and limited app access. PrEP choices (daily oral, 2-1-1 dosing, or injectable) can be switched during the study based on preference and medical advice, and visits include biospecimen collection to measure drug concentrations. The study uses four assessments over 36 weeks to track adherence, clinic attendance, knowledge, attitudes, self-efficacy, stigma, and other psychosocial factors.

Why it matters

Who can join: the full rules

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 it's running

• San Francisco Department of Public Health
  San Francisco, California, United States Recruiting
• Emory Atlanta Adolescent Consortium
  Atlanta, Georgia, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Lisa Hightow-Weidman, MD, MPH — Florida State University
• Study coordinator: Nancy Liu
• Email: NancyLiu@westat.com
• Phone: 718-980-3937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CHAMPION: Combining HIV Prevention and Meth Treatment for HIV-Negative MSM

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• ICONA Prevention Program for People Using PrEP in Italy

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  Recruiting at 18 sites Fondazione ICONA · Chieti, Abruzzo and 52 other locations · NCT07186244

• Bringing PrEP to a family planning clinic

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• Evaluating a PrEP implementation strategy for incarcerated individuals

  This study is testing a new way to help people in jail get access to PrEP and learn about HIV prevention to see if it can improve their health outcomes.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT06919419

• Predicting STIs in people using HIV prevention medication in Spain

  This study is trying to see if a new way to predict sexually transmitted infections can help people using HIV prevention medication in Spain stay healthier.

  Recruiting at 26 sites Hospital Universitario de Valme · Almería and 25 other locations · NCT06860945

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.