PrEP iT! Mobile App Intervention
Condition: Treatment Adherence and Compliance
Study type: Interventional

Summary: 
      The long-term goal of this research is to create an effective and sustainable program to
      support retention in PrEP care and PrEP adherence among 18-29 year old men who have sex with
      men (MSM). To reach this goal, we will develop and pilot test a mobile intervention tailored
      to young MSM, called PrEP iT! Primary aims include:

      Aim 1: Develop the PrEP iT! mobile intervention through focus groups with young MSM and
      refine iterations through input from a community advisory board (CAB).

      Aim 2: Conduct a pilot randomized controlled trial to assess the feasibility, acceptability
      and preliminary impact of the PrEP iT! intervention for young MSM.
    

Detailed description: 
      Study Design:

      We propose to evaluate the feasibility, acceptability and preliminary impact of PrEP iT! in a
      pilot RCT (n=80). Young men who have sex with men (YMSM) recently (re)initiating PrEP will be
      randomized to receive either PrEP iT! plus usual care or usual care alone, and followed for 6
      months with assessments at baseline, and 3- and 6-months.

      PrEP iT! will use open source software that conforms to current programming standards, and
      can be used across all devices (desktop, laptop, smartphone, and tablet) to ensure
      sustainability. PrEP iT! will be developed from feedback from PrEP-using YMSM through focus
      groups and a community advisory board (CAB). PrEP iT! is grounded in the Information,
      Motivation, and Behavioral Skills model, and also draws from a model of technology adoption.

      PrEP iT! intervention components are:

        -  PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring

        -  Tailored feedback on PrEP adherence/non-adherence

        -  PrEP and sexual health information tailored for YMSM

        -  Text message reminders for PrEP adherence and healthcare appointments

        -  An "ask the expert" feature

      Control arm participants will receive usual PrEP care only. Locally this entails, clinic
      visits every 3 months in the initial period following PrEP initiation, including HIV/STI
      screening and laboratory toxicity testing.

      Study Sample:

      Recruitment will be stratified by age in a 1:1 ratio (i.e., n=40 per group) of 18-24 and
      25-29 year olds, and will reflect 50% Black and/or Hispanic YMSM participation. This will
      allow us to explore subgroup differences (e.g., by age and race/ethnicity) for PrEP iT! to
      better inform future trials.

      Recruitment and Clinical Sites:

      Participants will be recruited from two clinics in Minneapolis that provide PrEP care. The
      clinical sites include the HIV clinic at Hennepin Healthcare (HH) and the Hennepin County STD
      clinic. We will recruit and enroll study participants concurrent with their PrEP clinical
      visits when possible.

      Participants will be recruited in four ways: a) PrEP clinic patients who are new or returning
      to care (i.e., are not currently receiving PrEP) will be identified by clinic staff and
      referred to research coordinators on the day of their clinic visit when possible; b) flyers
      will be hung in PrEP clinics and other HIV/AIDS NGO service organizations within the Twin
      Cities; and c) the study team will engage and solicit referrals from other community HIV/AIDS
      NGO with focused PrEP and prevention campaigns.

      Enrollment, Randomization, and Follow-up Visits:

      Study candidates will undergo a separate screening visit with a brief questionnaire at/after
      PrEP clinic visits. Participants will have a rapid HIV test as part of usual care. Persons
      whose test positive for HIV will be referred for same-day evaluation and care. Participants
      are randomized 1:1 to either the intervention (PrEP iT! + usual care) or control (usual care)
      arm. The randomization sequence will be stratified by age (18-24 v. 25-29 yrs) and use blocks
      of ten.

      After informed consent, participants will complete a computer-assisted baseline survey. All
      participants will be provided usual PrEP educational information encouraged to attend their
      regular healthcare visits. Participants randomized to the treatment arm (PrEP iT! + usual
      care) will be guided through setting up their user account and user profile, provided with
      basic training on how to navigate and use intervention components, and given the opportunity
      to ask questions. YMSM in the treatment arm will have immediate access to PrEP iT! after the
      initial visit.

      YMSM will undergo a 3- and 6-month follow-up assessment, with multiple reminders sent to
      participants prior to each visit. The 3- and 6-month stud procedures include completing a
      short computerized assessment, and submitting a dried blood spot specimen for the TFV-DP
      analyses. Study data will also be collected from the month 3 and month 6 healthcare visits
      that include laboratory and clinical data generated routinely as part of standard PrEP care
      (e.g., testing for HIV Ab and other STIs). We anticipate that most HIV tests results data
      will be extracted from participant's medical record to confirm their HIV-negative status. In
      the event that we must conduct an HIV test (e.g., we are unable to extract that from the
      medical record or if there is an expressed concern that the participant's HIV status has
      changed), they will be conducted at the Hennepin Healthcare clinical laboratory, using
      standard clinical assays (we use the HIV Ab/Ag combination test for diagnosis). This
      information would be captured in our CRFs via REDCap, and this information will be securely
      transferred to SDSU but would be via a de-identified file.

      Study retention protocols involve the use of multiple contact methods, including telephone
      calls, text messages and e-mail reminders. We anticipate no more than 20% attrition.

      Exit Interviews: A random subset of participants randomized to the PrEP iT! arm will be asked
      if he would be willing to participate in 30-60 minute exit interview to assess a) his
      experience in the intervention, b) suggestions for modifications to the existing interface,
      c) suggestions for new features; and d) and changes to the study procedures. Recruitment for
      exit interviews will entail sufficient numbers for the goal of achieving ten men completing
      the exit interview.
    

Intervention name(s): PrEP iT! (plus usual PrEP care); Usual PrEP care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The PrEP iT! intervention is a mobile-optimized website, with the following components:
PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
Tailored feedback on PrEP adherence/non-adherence
PrEP and sexual health information tailored for YMSM
Text message reminders for PrEP adherence and healthcare appointments
An "ask the expert" feature; Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2-arm RCT with 1:1 randomization to PrEP iT! group or the usual care control group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pre-Exposure Prophylaxis (PrEP; HIV Prevention