Life Steps for PrEP for Youth
Condition: HIV; Pre-exposure Prophylaxis; Medication Adherence
Study type: Interventional

Summary: 
      This is a formative study, designed to provide information required to tailor Life-Steps for
      Pre-Exposure Prophylaxis (PrEP), an evidence-based cognitive behavioral adherence
      intervention, to enhance PrEP uptake and adherence in high risk young men who have sex with
      men (YMSM) and young transgender women who have sex with men (YTWSM).

      Life-Steps for Pre-exposure prophylaxis (PrEP) is a manualized modular adherence intervention
      based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the
      intervention to focus on the greatest challenges that they perceive in maintaining optimal
      adherence to PrEP.
    

Detailed description: 
      Aim 1:

      To adapt Life-Steps for Pre-Exposure Prophylaxis (PrEP) to be culturally relevant and
      appropriate for at-risk young men who have sex with men (YMSM) and transgender women who have
      sex with men (TWSM). The investigators will conduct in-depth qualitative interviews with up
      to 20 HIV-uninfected, at risk YMSM/TWSM at Fenway Health, an Adolescent Trials Network (ATN)
      clinical center. The investigators will also conduct in-depth, individual qualitative
      interviews with up to 10 key informants, including PrEP providers and staff at
      community-based organizations that work with YMSM/TWSM. Through these interviews, perceived
      facilitators and barriers to initiating and adhering to PrEP will be identified, and
      potential strategies to optimize adherence to PrEP for YMSM/TWSM. The investigators will
      explore youth perspectives on the use of nurses to deliver health messages and weekly text
      messages. YMSM/TWSM will be recruited at various points in the PrEP continuum of care,
      including those have opted not to initiate PrEP despite recommendations from clinicians,
      those who are using PrEP who report high levels of adherence and those who report adherence
      challenges through clinician referrals and direct recruitment in clinic waiting areas.
      Interviews will last approximately 60 minutes and will be digitally-recorded. Recordings will
      be transcribed and analyzed rapidly to inform the design of the youth-tailored Life-Steps for
      PrEP for YMSM/TWSM that we will test in Aim 2.

      Aim 2:

      To conduct a 2-arm pilot randomized control trial (RCT) to assess feasibility and
      acceptability of the Life-Steps for PrEP for youth intervention and preliminary efficacy of
      the intervention to improve PrEP adherence and retention in PrEP care compared to the
      standard of PrEP care at three different clinical sites. Investigators will enroll 50
      YMSM/TWSM in the RCT (randomized 1:1 to the 2 arms) across the 3 sites. The primary efficacy
      outcomes will be PrEP adherence-as measured by dried blood spot testing -and retention in
      PrEP care-as measured by attendance at quarterly clinic appointments-at 3 and 6 months post
      baseline. Secondary outcomes include changes in sexual behaviors, retention in prevention
      services, and acceptability of the interventions which will be assessed at each major visit.
      Investigators will also conduct a brief, 15-minute semi-structured exit interview with
      participants in the Life-Steps for PrEP for youth intervention arm to provide an opportunity
      for more in-depth (open-ended) feedback on intervention satisfaction and acceptability. These
      data will be used to finalize the intervention manual to enhance participant acceptability.
    

Intervention name(s): Life Steps for PrEP for Youth
Intervention type(s): Behavioral
Intervention description(s): Life-Steps is a modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to pre-exposure prophylaxis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention