Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS)

Westat

Status: Not yet enrolling

Conditions: PrEP Adherence; HIV; PrEP

Treatments: Other: LYPS; Other: Enhanced Standard of Care

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07438041

ATN165

Details and patient eligibility

About

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.

Full description

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 that evaluate components of the LYPS intervention, tailored for intervention and eSOC conditions. Blood (dried blood spot [DBS] and plasma) will be collected to evaluate PrEP drug concentrations and stored for additional study-related testing.

All participants will receive daily oral PrEP, oral PrEP taken using a 2-1-1 dosing strategy, or injectable PrEP based on their preference and in consultation with their PrEP provider. There is no randomization involved for PrEP provision and participants are allowed to switch between oral and injectable PrEP or vice versa during the study. PrEP care visits (quarterly for those on oral PrEP and two monthly injections followed by an injection every two months for those on injectable PrEP) will include clinical labs such as HIV and STI testing and focused physical exams for signs and symptoms of HIV infection. Other relevant clinical data collected as part of the participant's PrEP clinical care will also be collected.

Enrollment: 272 estimated patients

Sex: All

Ages: 13 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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272 participants in 2 patient groups

LYPS Intervention

Experimental group

Description:

PrEP and PrEP care will be delivered to youth in the communities where they live through a Community Health Professional (CHP) (e.g., a nurse or other qualified health care professional home, friend's home, community venue or clinic, mobile health clinic), supplemented by a mobile app to provide real-time intervention between CHP visits.

Treatment:

Other: LYPS

Enhanced Standard of Care (eSOC) Control Condition

Active Comparator group

Description:

Usual standard of care clinic-based PrEP, enhanced with access to a limited number of LYPS app components, including basic PrEP adherence information and study visit reminders.

Treatment:

Other: Enhanced Standard of Care