Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services

Official title

Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services (LYPS): An Innovative Mobile Delivery and Mobile Health (mHealth) Intervention to Optimize PrEP Adherence and Persistence

Overview

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.

Detailed 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.

Interventions

• Other LYPS
  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.
• Other Enhanced Standard of Care
  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.

Primary outcome measures

• PrEP adherence at 6 months [Time frame: 6 months]
• PrEP persistence at 6 months [Time frame: 6 months]

Secondary outcome measures (2)

• PrEP adherence at 9 months [Time frame: 9 months]
• PrEP persistence at 9 months [Time frame: 9 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 4 centers

• San Francisco Department of Public Health — San Francisco
• Emory Atlanta Adolescent Consortium — Atlanta
• Johns Hopkins University — Baltimore
• Baylor College of Medicine — Houston

Identifiers

NCT: NCT07438041 · ATN165

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗