P3 (Prepared, Protected, emPowered)
Condition: Sexually Transmitted Diseases; Safe Sex; Adherence, Medication
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM
      and YTW that utilizes social networking and game-based mechanics as well as a comprehensive
      understanding of what constitutes "best practices" in app development to improve PrEP
      adherence and persistence in PrEP care.
    

Detailed description: 
      Sustainable, integrated PrEP adherence interventions are critically needed to reduce HIV
      incidence among YMSM and YTW. It is imperative that the investigators develop adherence
      interventions for YMSM and YTW initiating PrEP that are engaging, age-appropriate and take
      advantage of technologies that are already embedded in these individual's lives. A
      smartphone-delivered PrEP adherence intervention is well suited for this population, given
      they have a high-uptake and utilization of smartphone technology. The use of smartphones to
      deliver HIV prevention and care interventions has grown substantially in recent years due to:
      a) wide-scale adoption of smartphone technology among high-risk groups, b) the ability to
      deliver interventions in real-time within risk contexts, and c) low implementation costs.The
      accessibility, affordability, anonymity and acceptability of smartphones make them the
      intervention medium of choice for engaging youth and a logical platform to deliver an
      adherence intervention targeting PrEP. Further, smartphone interventions address can overcome
      issues that impede engagement with in-person interventions such as transportation logistics,
      stigma and confidentiality. Further youth, including YMSM and YTW are receptive to smartphone
      delivered interventions and these interventions can impact HIV related prevention behaviors.

      P3 (Prepared, Protected, emPowered) is an interactive smartphone app for HIV-uninfected YMSM
      and YTW that utilizes social networking and game-based mechanics as well as a comprehensive
      understanding of what constitutes "best practices" in app development to improve PrEP
      adherence and persistence in PrEP care. Built on a successful, evidence-based platform
      designed and tested by our collaborating technology partner, Ayogo, P3 is flexible and
      responsive to changes in technology. This flexibility will also allow us to quickly respond
      to and modify our intervention to align with emerging PrEP practice standards and guidelines.

      Despite the benefits of app-based interventions, maintaining engagement over time can be
      particularly challenging. Lack of rapport building may contribute to lower retention rates in
      technology-based interventions. Further, the available literature suggests that some tools,
      including technology based tools, may be more beneficial to patient adherence when combined
      with education or counseling. To investigate this possibility, the investigators will include
      a study arm (P3+) that includes P3 and adherence counseling delivered by a counselor through
      the P3 app.

      This study has three phases, usability testing, field testing, and a randomized-controlled
      trial (RCT). In usability testing the investigators will test beta versions of the app and
      gain feedback about the intervention from the target population, identify any technical
      issues, and get feedback on app content. Field testing is to ensure that the features,
      platform and content of P3 and P3+ are acceptable to the target population and that there are
      no technical challenges or user concerns with either the app, the dried blood spot (DBS),
      hair, or mitra sampling collection.

      The last phase is a three arm, RCT that will test the efficacy of P3, a novel, theory-based
      mobile app that utilizes game mechanics and social networking features to improve PrEP
      adherence, retention in PrEP clinical care, and PrEP persistence among young men who have sex
      with men (YMSM) and young trans women (YTW) who have sex with men, ages 16-24. The
      investigators will test the efficacy of P3 and P3+, which adds Next Step Counseling delivered
      by an adherence counselor through the app, against PrEP standard of care. Participants will
      be randomized to P3, P3+, or standard of care. A cost comparison between P3 and P3+ will be
      conducted.
    

Intervention name(s): P3; P3+; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.; In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.; Control participants will receive the standard of care for receiving a prescription for PrEP.
Other intervention name(s): Prepared, Protected, emPowered
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The trial will consist of a three-arm RCT to test intervention efficacy among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM) who are starting PrEP or are non-adherent to PrEP. Study arms will include P3, P3+, and standard of care (SOC). Participants will be recruited from seven cities. The investigators will enroll up to 240 participants and randomize them 1:1:1 to receive P3, P3+, or SOC. Assessments will be completed at months 0, 3, and 6.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrEP; gamification; mHealth; HIV prevention; truvada; eHealth; app; adherence; ymsm; transgender women