PrEP2Prevent An Online PrEP Navigation and Activation Intervention
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      -  The goal of this clinical trial entitled, PrEP2Prevent: An Online PrEP Navigation and
           Activation Intervention for YMSM, is to develop and test a method for supporting access
           to an HIV prevention medication called Pre-Exposure Prophylaxis (PrEP) in young men who
           have sex with men and young transgender and non-binary individuals. The main questions
           it aims to answer are:

        -  What are some of the experiences and barriers providers have seen regarding this
           population accessing PrEP

        -  Using information gathered from PrEP providers and navigators, develop a mobile health
           platform and PrEP related content that will be tested by members of the population to
           see if the features are usable and the content is understandable.

        -  Enroll 150 study participants to see if utilizing the mobile health platform and
           receiving supportive sessions related to motivation and barriers to accessing PrEP is
           achievable.

        -  Participants will

        -  Be given access to the mobile health Platform called PrEPresent, which provides them
           with access to prevention related content, the ability to schedule with a patient
           navigator and create customizable goals

        -  Complete a baseline, 3 month and 6 month assessment about personal health, health
           history and technology, along with a PrEP adherence rapid urine test

        -  Complete up to 4 sessions to assist participants in the intervention group with
           discussing any barriers to accessing PrEP
    

Detailed description: 
      The U.S. Department of Health and Human Services (HHS) has set a goal to end the HIV epidemic
      by the year 2030, which is well within reach given the availability of antiretrovirals that
      effectively prevent and treat HIV. But success can only be achieved if targeted approaches
      are implemented with at-risk populations to address known barriers of engagement along the
      pre-exposure prophylaxis (PrEP) and HIV care continua. In response, obtained funding from
      NIH, using the R34 mechanism, with the goal of the research being to develop and pilot test a
      PrEP activation, navigation and support intervention for YMSM, including young Black and
      Latino YMSM (B-YMSM, L-YMSM), who not only have the highest annual incidence of HIV but who
      are also the least likely to have ever used PrEP. There is very clear evidence demonstrating
      that while YMSM have high levels of knowledge about and intentions to use PrEP, few have ever
      used PrEP. Our own research demonstrate the urgent need for interventions that specifically
      target PrEP uptake while also addressing a complex array of individual (e.g., side effect
      concerns, substance use, depression), sociocultural (e.g., internalized homophobia,
      PrEP-related stigma), and structural (e.g., access to care, medication costs) barriers to
      PrEP uptake. Our research also demonstrates that such an intervention should include four
      components: 1) inclusion of PrEP and other service navigation; 2) provision of skills to
      address patient activation, reduce PrEP-related stigma, and increase PrEP self-efficacy; 3)
      peer/social support; and 4) utilize a mobile health (mHealth) platform or similar technology
      that supports both in-person and virtual intervention delivery (text and live video chat).
      Based on these findings, the investigators propose to conduct research with the following
      specific aims

      Specific Aim 1: Conduct formative research to inform the development of a PrEP activation,
      navigation and support intervention, which the investigators call PrEP2Prevent. Qualitative
      data will be collected using structured guides from working/focus groups with YMSM, Trans,
      and gender non-conforming youth and during Key Informant Interviews (KII) with existing PrEP
      care providers/navigators. These data will inform intervention content and
      activation/navigation services.

      Specific Aim 2: Develop and then conduct usability testing of PrEP2Prevent, including both
      the intervention content and mHealth delivery platform. Data from Aim 1 will inform the
      content and structure of intervention components to be included. During intervention
      development, two rounds of usability testing will be conducted with 8-10 YMSM, Trans, and
      gender non-conforming youth to ensure features are usable and the content is understood.
      Internal beta testing will be performed to assess for full technical functionality.

      Specific Aim 3: Evaluate the feasibility, acceptability and preliminary efficacy of
      PrEP2Prevent with a racially/ethnically diverse sample of 150 (50 Non-Hispanic Whites, 50
      Blacks/African American, 50 Latino/Hispanic) YMSM, Trans, gender non-conforming youth, ages
      16-26 years. Participants will be randomly assigned in a 1:1 ratio to the intervention app
      (PrEP2Prevent) or control app (standard of care). Primary outcomes are feasibility,
      acceptability and preliminary efficacy. Feasibility data will include sources and rates of
      recruitment/retention, barriers and facilitators to recruitment/retention, engagement with
      PrEP navigator both in-person and via mHealth platform, as well as paradata on the mHealth
      platform use (e.g., number of log-ins, time spent, chatroom/text-based discussions).
      Acceptability will be assessed using a survey with validated measures at intervention
      completion. Preliminary efficacy will include linkage to PrEP services and PrEP uptake, these
      data will be collected at baseline and at 3- and 6-months following completion of the
      intervention. Mediators/moderators will include PrEP self-efficacy, PrEP stigma, and patient
      activation. The findings from this research will inform further refinements to the
      intervention and provide estimates of possible intervention effect sizes (group means, SDs)
      for a future randomized controlled trial (RCT). The funded research is highly significant,
      timely and innovative. Its innovation lies in the fact that it: a) targets an intervention
      for YMSM where it is most needed - e.g., on PrEP uptake; b) recognizes that YMSM require
      tools and support to successfully navigate PrEP services; and c) uses mHealth to deliver the
      intervention. Moreover, the intervention can be used for both engagement and re-engagement in
      PrEP uptake for YMSM who cycle in and out of PrEP care. Further, the intervention is
      potentially easily adaptable and transferable to address other critical PrEP and HIV needs
      (e.g., uptake of long-acting PrEP and antiretroviral therapy [ART]).
    

Intervention name(s): PrEPresent
Intervention type(s): Behavioral
Intervention description(s): PrEP2Prevent is being done in several phases (parts) to develop and pilot test a PrEP activation, navigation and support intervention for young men who have sex with men (YMSM), trans youth and non-binary youth in Los Angeles. It targets an intervention for these young people where they need it most - on PrEP uptake. PrEP stands for pre-exposure prophylaxis.
Other intervention name(s): PrEP2Prevent
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrEP; Mobile Health; LGBTQ; Transgender; Adolescent