Westat
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…
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 gui…
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.
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.