Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-24
SponsorWestat
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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
Trial design
Treatments tested in this trial
- LYPS
- Enhanced Standard of Care
Treatment groups
272 Participants
are divided into 2 treatment groupsSponsors and collaborators
Westat
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
National Institutes of Health (NIH)
Collaborator
Florida State University
Collaborator
The Emmes Company, LLC
Collaborator
Source ClinicalTrials.gov