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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03577301
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : October 26, 2018
Information provided by (Responsible Party):
Florida State University

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Clinic-based Delivery Behavioral: Remote Delivery Not Applicable

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 270 YMSM, ages 15-24, 90 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: 270 YMSM across three sites (90 per site), 135 in each condition

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Effectiveness Trial of Clinic-Based Delivery of an HIV Risk Reduction Intervention for Young Men Who Have Sex With Men (YMSM)
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.
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.
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.

Primary Outcome Measures :
  1. Sexual Self Management Change [ Time Frame: 3 Month Interval ]
    Computer Assisted Self Interview (CASI) scored through Qualtrics

  2. Sexual Health Management Change [ Time Frame: 3 Month Interval ]
    Serologic lab test of blood sample - positive or negative for HIV and other Sexually Transmitted Infections (STIs)

  3. Substance Abuse Change [ Time Frame: 3 Month Interval ]
    Nucleic Acid Amplification (NAA) Urinalysis Drug Screen

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

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
  • ≥ 5 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03577301

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Contact: Tyrel Starks, PhD 212-206-7919

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United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Lawrence Friedman, PhD   
Contact: Donna Maturo   
Principal Investigator: Lawrence Friedman         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Anguliqe Outlaw, PhD   
Contact: Monique Green-Jones, PhD    313-577-0792   
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Tanney   
Contact: Kim Desir   
Principal Investigator: Mary Tanney         
Sponsors and Collaborators
Florida State University
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Principal Investigator: Sylvie Naar, PhD Florida State University
  Study Documents (Full-Text)

Documents provided by Florida State University:
Study Protocol  [PDF] January 19, 2017

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Responsible Party: Florida State University Identifier: NCT03577301     History of Changes
Other Study ID Numbers: ATN145
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Florida State University:
Men Who Have Sex with Men (MSM)

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases