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Completed

NCT Number: NCT03577301

Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse

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.

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Key information

Age range

15 year–24 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Miller School of Medicine, Miami, Florida, United States

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About this study

  • 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.
  • 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.
  • 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
  • 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.
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-negative test result from the past 90 days
  • 15-24 years of age
  • Born biologically male or currently identifying as male
  • Sex with men in the past 90 days
  • ≥ 3 days of illicit drug use in the past 90 days
  • ≥ 1 episode of Condomless Anal Sex (CAS) in the past 90 days, or a positive STI test result in the past 90 days.
  • Able to communicate in English

Exclusion criteria

  • Serious cognitive or psychiatric impairments
  • Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)

Treatment and study plan

Clinic-based Delivery

Behavioral

A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.

Remote Delivery

Behavioral

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.

Multi-modal Delivery

Behavioral

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.

Primary outcomes

  1. Illicit Drug Use Days

    Time frame: baseline, 3 months, 6 months, 9 months, 12 months

    The self-reported number of illicit drug use days (not including marijuana) in the past 30 days

  2. Condomless Anal Sex Acts

    Time frame: baseline, 3 months, 6 months, 9 months, 12 months

    The self-reported number of condomless anal sex acts with male partners in the last 30 days prior to assessment point.

  3. Marijuana Use Days

    Time frame: baseline, 3 months, 6 months, 9 months, 12 months

    The self-reported number of marijuana use days in the past 30 days prior to assessment point.

Secondary outcomes

  1. Alcohol Use Days

    Time frame: baseline, 3 months, 6 months, 9 months, 12 months

    The self-reported number of alcohol use days in the past 30 days

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Comparative Effectiveness Trial of Clinic-Based Delivery of an HIV Risk Reduction Intervention for Young Men Who Have Sex With Men (YMSM)

Acronym: YMHP

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2018
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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