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Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services

Sponsored by Westat

About this study

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.

LYPS is a two-arm randomized controlled trial (RCT) to assess the efficacy of the LYPS intervention. Up to 272 participants will be randomized in a 1:1 ratio to receive either the LYPS intervention or enhanced standard of care (eSOC) (136 participants per arm). The eSOC control condition will consist of usual clinic-based PrEP care and access to a limited number of LYPS app components. Participants will complete four research assessments, at Enrollment and Weeks 12, 24, and 36, that include computer-assisted self-interviews (CASIs) and blood collection. CASIs will collect information including, but not limited to, demographics, PrEP adherence and persistence, PrEP clinic visit attendance, PrEP knowledge and attitudes, PrEP self-efficacy, PrEP stigma, and psychosocial variables, questions t…

Where this study is enrolling (4)

Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.