Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      YMHP is a counseling intervention program for which the goals are to better understand
      HIV-prevention focused self-management behaviors among HIV-negative YMSM, and to study the
      implementation of YMHP to improve portability and scalability. The clinic sites will help
      investigators to assess and address practical problems at the frontline of service provision
      to pave the way for a comprehensive program to reduce HIV infection among YMSM that reflects
      the complexities of real world adolescent HIV clinics.
    

Detailed description: 
      1. Adapt YMHP for clinic and phone delivery by existing HIV clinic staff community health
           workers (CHWs), who work with YMSM ages 15-24. Investigators will conduct focus groups
           with staff to obtain input on how best to implement YMHP to maximize feasibility,
           acceptability, and sustainability, as well as issues with adapting the YMHP for delivery
           to YMSM ages 15-18 and for phone delivery.

        2. Compare the effectiveness of clinic-based versus phone-based delivery of YMHP in the
           context of health care access. In order to inform future implementation, investigators
           will test the effectiveness of YMHP delivered via these two modalities.

             1. Assess the cost-effectiveness of both delivery formats of YMHP to enhance the
                likelihood of uptake of this best evidence intervention. The hypothesis is that
                phone-based will be more cost-effective than clinic-based

             2. Assess the Five Components of the Self-Management Model and how these components
                vary over time, are directly improved by the interventions, and mediate
                intervention effects.

        3. Test a sustainable model of YMHP implementation in real world adolescent clinics.
           Investigators will utilize local supervisors within the clinic setting to sustain the
           CHWs fidelity to delivering the motivational interviewing (MI)-based YMHP intervention.
           Fidelity will be monitored throughout the trial and assessments and qualitative
           interviews will be conducted with key stakeholders to determine the barriers and
           facilitators of YMHP implementation utilizing the Exploration, Preparation,
           Implementation, Sustainment model (EPIS).

      Aims will be achieved over two phases of the study.

      Phase I: Investigators will conduct research (Exploration and Preparation phases of EPIS
      model) to obtain implementation feedback to best adapt YMHP for clinic-based CHWs, further
      incorporate PrEP navigation services, and expand the YMHP protocol to be relevant for
      Telephone-based Motivational Interviewing (TBMI). We will train a minimum of 2 CHWs at each
      clinic drawing on the Implementation Science Core (ISC) to apply best-practices in training.
      Once CHWs demonstrate competence according to the Motivational Interviewing Treatment
      Integrity (MITI), Phase 2 will begin.

      Phase II: Personnel will recruit and enroll 180 YMSM, ages 15-24, 60 at each of the three
      sites. Sessions will be audio-recorded for MITI fidelity coding, and CHWs and supervisors
      will be given implementation support throughout. Prior to implementation, immediately at the
      conclusion of the intervention delivery phase, and one year after, the ISC will conduct
      interviews with CHWs, supervisors, and clinic leaders to obtain information about the
      barriers and facilitators of implementation and sustainment.

      Target n: 180 YMSM across three sites (60 per site).
    

Intervention name(s): Clinic-based Delivery; Remote Delivery; Multi-modal Delivery
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.; A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.; A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Intervention; Men Who Have Sex with Men (MSM); PrEP; YMHP; YMSM