ATN 165: Linking Youth to PrEP Services

Study Summary:

The goal of the ATN 165 study, “Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services” (LYPS), is to improve pre-exposure prophylaxis (PrEP) adherence and persistence among young transgender women and gay, bisexual and other sexual minority men. LYPS is a multi-level intervention with two main features. The first feature is delivery of PrEP medication and PrEP services by a community health professional (CHP) at a place the participant chooses (for example, in the home or a private room in a community center). The second feature is a digital health platform (smartphone app) that offers PrEP support tools like tailored health information, social support, skill-building activities, and medication adherence tracking.

What is the study trying to discover?

The LYPS intervention is trying to discover whether removing structural barriers (for example, transportation) to getting PrEP care and providing tailored PrEP adherence support tools helps more youth and young adults take their PrEP successfully over time to reduce the likelihood of acquiring HIV.

Why is this study important?

PrEP is highly effective at preventing HIV and is now covered by almost all health insurance plans, Family Planning Medicaid, and drug assistance programs. However, getting and staying on PrEP is still challenging for many young people due to structural and individual barriers that include long distances to the PrEP clinic, inaccessible clinic locations, limited office hours, lack of adolescent friendly sexual health services, and stigma and discrimination. Home- and community-based care delivery models could improve PrEP use for persons in communities who have a hard time accessing PrEP due to greater health inequities. This way of providing services could provide more options for individuals who would like to access PrEP and support people who might otherwise stop using PrEP after initially trying it.

Who is this study for?   

This study is for transgender women and gay, bisexual and other sexual minority men, ages 13-24 years who are on PrEP or are PrEP eligible. The study will be available in English and Spanish.

What happens during the study?

Participants will be screened for eligibility and enroll into the study at a participating ATN site consortium partner location. After enrolling in the study, participants will be randomly assigned to receive either the full LYPS intervention or usual PrEP care provided at their study enrollment site. For the next 9 months, participants in the LYPS intervention condition will complete their subsequent PrEP care visits at a location of their choice outside of the clinic. The usual care arm will receive PrEP care at the participating clinic. Both the LYPS intervention arm and the usual care arm will receive training on a smartphone app that they can access for the duration of the study. Oral PrEP (that is, PrEP as a pill) and long-acting injectable PrEP will be provided for all participants as part of the study.