Y2Prevent: Preventing Drug Use and HIV Through Empowerment, Social Support and Mentorship (Y2P)
Condition: HIV; Drug Use
Study type: Interventional

Summary: 
      The goal of this clinical trial is to pilot test a group level intervention, called
      Y2Prevent, which aims to decrease drug use and HIV/STI risk among Black/African American
      young men who have sex with men (AAYMSM). The main question it aims to answer is:

      • determine if Y2Prevent is possible to engage in easily and is accepted by the participants,
      for potential expansion to other cities.

      Participants will engage in 7 weekly group sessions focused on helping AAYMSM identify life
      goals and safeguard their health to achieve those goals. This intervention will also include:

        -  HIV/STI testing and treatment referral

        -  drug screening and treatment referral

        -  positive youth development and future planning through a mentorship program
    

Detailed description: 
      The overarching aim is to develop a culturally tailored and developmentally appropriate HIV
      prevention intervention for African American young men who have sex with men (AAYMSM), ages
      18 to 24 years. No group is at greater risk for acquiring HIV than YMSM, especially those
      living in inner cities, with AAYMSM now accounting for the largest number of new HIV
      infections detected in cities each year. If these trends continue, it is estimated that as
      many as 1 in 2 AAYMSM will be diagnosed with HIV in their lifetime.

      The investigators propose to further refine and pilot test an intervention, called Young
      Men's Adult Identity Mentoring (YM-AIM). Adapted from an existing CDC Diffusing Effective
      Behavioral Intervention (DEBI), YM-AIM is a theory-driven, group-level intervention designed
      to help AAYMSM develop a healthy vision for their future (or "possible future self") by
      defining a set of short- and long-term goals in the areas of education, health, family and
      intimate relationships. Through the facilitated activities, participants consider how their
      involvement in risky behaviors (e.g., illicit drug use, condomless sex, multiple sex
      partners) would interfere with achieving those goals. With funding from NIDA (R21 DA024588),
      the investigators developed YM-AIM in response to findings from our own research, as well as
      those reported in the literature, which demonstrate that experiences of minority stress
      (e.g., racism, homophobia) and exposure to violence and victimization (family, intimate
      partner, community) put AAYMSM at significantly greater risk for illicit drug use, HIV/STI
      sexual risk (condomless anal sex), and mental health problems (e.g., depression) as compared
      to Caucasian and Hispanic/Latino YMSM.

      During our initial pilot, participants (n=36) were enormously enthusiastic about their
      participation in YM-AIM (all participants attended all six weekly sessions), they provided
      positive feedback about the various components, activities, and exercises, and they reported
      that YM-AIM should continue to be delivered using a group-based intervention because they
      enjoyed the support provided by other group members. Participants also reported they wanted
      (and needed) ongoing social support after completing the intervention, to help them achieve
      their short- and long-term goals and maintain positive changes in sexual risk behaviors. This
      feedback is consistent with the literature that suggests mentors are immensely beneficial,
      particularly for youth and young adults, because they can share their worldviews,
      experiences, knowledge, support and advice, as well as provide a positive influence. By
      introducing youth to new experiences and sharing positive values, mentors can help young
      people avoid negative behaviors and achieve success. Having a mentor has also been found to
      reduce youths' risk for delinquency, aggression and drug use and lead to increased academic
      satisfaction and performance. Based on this, the investigators propose to further strengthen
      and refine YM-AIM by adding a youth mentoring/support component, called Youth Initiated
      Mentoring (YIM). YIM uses a positive youth development framework to help young, low-income
      ethnic/racial minorities: a) build social capital to achieve immediate and long-term life
      goals, b) build social support networks, c) identify and engage natural mentors in their
      networks to address structural barriers encountered in their lives, and d) develop
      relationships with supportive adults.

      YM-AIM was developed in 2011, before widespread availability of PrEP/PEP. The investigators
      are therefore also proposing to add three new components: 1) biomedical HIV prevention
      strategies (PrEP, PEP), 2) HIV/STI testing and treatment referral, and 3) drug screening and
      treatment referral. This new intervention, which is called Y2Prevent, will then be evaluated
      for its feasibility and acceptability. Intervention outcomes include drug use in past 30 days
      and 3 months, alcohol use, condomless sex, number of partners, condom use intention, condom
      use self-efficacy, HIV testing recency/frequency, and linkage to care. The specific aims are
      to:

      SPECIFIC AIM 1: Conduct formative research to develop Y2Prevent and refine our assessment
      measures.

      SPECIFIC AIM 2: Finalize Y2Prevent study protocols and consents and develop a manual of
      operations.

      SPECIFIC AIM 3: Pilot and evaluate Y2Prevent to determine intervention feasibility and
      acceptability, and collect prelimiary efficacy data.

      e propose to integrate YM-AIM and YIM into a single new intervention, called Y2Prevent. This
      intervention will then be implemented and evaluated for feasibility and acceptability, and
      manualized. Three phases of research are proposed. In Phase 1, the investigators will conduct
      formative research to integrate YM-AIM and YIM and refine our assessment battery (Aim 1). In
      Phase 2, the investigators will finalize the study protocols and consents and develop a
      manual of operations (Aim 2). In Phase 3, investigators will pilot test Y2Prevent with 30
      participants. Assessment measures will also be pilot tested during three assessment sessions,
      at baseline (first study visit) and 3- and 6-month follow-up (after post-intervention test).
      Intervention outcomes include drug use in past 30 days and 3 months, alcohol use, condomless
      sex, number of partners, condom use intention, condom use self-efficacy, HIV testing
      recency/frequency, and linkage to care. Findings from this pilot research will inform
      selection of measures and outcomes for a future randomized clinical trial (RCT) and provide
      estimates of possible intervention effect sizes (group means, SDs) for trial planning.
      Process measures include data on sources of recruitment and recruitment rates, trial
      retention rates, and identification of barriers and facilitators to recruitment and
      retention.

      WORKING GROUPS - PHASE 1:

      During Phase 1, the investigators will convene two working groups of AAYMS to engage in a
      process of integrating the Young Men's Adult Identity Mentoring (YM-AIM) and Youth Initiated
      Mentoring (YIM). Each work group will include 8-10 young men. These men will be recruited
      from our existing HYM cohort.

      Prior experience has taught us that creating groups with shared key characteristics (e.g.
      risk profile, sexual identity or age) is the most effective means of facilitating more
      in-depth discussions. Each group, consisting of 6-8 members, will be convened on a weekly
      basis and each meeting will focus on one specific topic (i.e.,common challenges that AAYMSM
      experience with HIV prevention; what AAYMSM want from a mentor) - there will be around 7
      weekly lessons that participants will attend. During these meetings, participants will review
      each unit of the original YM-AIM and YIM curricula and discuss what components would be most
      relevant. Groups will be facilitated by the research assistant, and each week a volunteer
      from each group will be asked to serve as a co-facilitator in an effort to increase ownership
      for intervention adaptation and to assist in maintaining order within the group.

      Guided discussions will focus on different aspects of the curricula such as: 1) common
      challenges that AAYMSM experience with HIV prevention; 2) what AAYMSM want from a mentor; 3)
      managing positive and negative influences in their lives; 4) challenges in accessing care;
      and 5) the role that intimate partners play in their lives. The investigators will brainstorm
      potential activities that can be integrated into our newly adapted Y2Prevent curriculum that
      focus on these areas (e.g., PrEP Myth or Truth game).

      PILOT TEST - PHASE 3: In Phase 3, the investigators will pilot test Y2Prevent with three
      working groups of African American young men who have sex with men (AAYMSM) in Los Angeles.
      Each group will have up to 10 members (n=30). The intervention will be delivered to the three
      groups in a sequential order so that the experiences from the first group can be used to
      adapt and/or further refine the intervention before it is pilot tested with the second group.
      Feedback from the first group will be used to further adapt and refine the intervention. It
      will be pilot tested again with a second group of 10 participants. Y2Prevent will be further
      refined as needed, and it will then be pilot tested with a third and final group of up to ten
      participants. The investigators will continue to gather information, solicit input, and
      refine Y2Prevent until the investigators are satisfied that the intervention is truly
      relevant, acceptable, and appropriate for the target population. These group discussions will
      be audio-recorded and professionally transcribed for analysis. The focus groups are expected
      to last 1.5 - 2 hours each.
    

Intervention name(s): Y2Prevent
Intervention type(s): Behavioral
Intervention description(s): Y2Prevent (Y2P) is a groupl level intervention that consists of 7 weekly group sessions focused on helping young African American men who have sex with men (AAYMSM) identify life goals and safeguard their health to achieve those goals
Intervention model: Single Group Assignment
Intervention model description: In Phase 3, we will pilot test Y2Prevent with three groups of African American young men who have sex with men (AAYMSM) in Los Angeles. Each group will have up to 10 members (n=30). The intervention will be delivered to the three groups in a sequential order so that the experiences from the first group can be used to adapt and/or further refine the intervention before it is pilot tested with the second group. Feedback from the first group will be used to further adapt and refine the intervention. It will be pilot tested again with a second group of 10 participants. Y2Prevent will be further refined as needed, and it will then be pilot tested with a third and final group of up to ten participants.
Masking: None (Open Label)
Primary purpose: Prevention