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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Clinic-based Delivery; Behavioral: Remote Delivery; Behavioral: Multi-modal Delivery

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).

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Wayne State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinic-based Delivery; Participants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.	Behavioral: Clinic-based Delivery; A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
Active Comparator: Remote Delivery; Participants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.	Behavioral: Remote Delivery; 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.
Active Comparator: Multi-modal Delivery; A 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019.	Behavioral: Multi-modal Delivery; 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.
No Intervention: Treatment as Usual; Treatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illicit Drug Use Days	The self-reported number of illicit drug use days (not including marijuana) in the past 30 days	baseline, 3 months, 6 months, 9 months, 12 months
Condomless Anal Sex Acts	The self-reported number of condomless anal sex acts with male partners in the last 30 days prior to assessment point.	baseline, 3 months, 6 months, 9 months, 12 months
Marijuana Use Days	The self-reported number of marijuana use days in the past 30 days prior to assessment point.	baseline, 3 months, 6 months, 9 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Days	The self-reported number of alcohol use days in the past 30 days	baseline, 3 months, 6 months, 9 months, 12 months

Collaborators and Investigators

• Sponsor: Florida State University
• Investigators: Principal Investigator: Sylvie Naar, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2018
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HIV; YMSM; PrEP; Intervention; Men Who Have Sex with Men (MSM); YMHP
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: ATN145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No