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Completed

NCT Number: NCT03488914

Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color

This study will conduct an effectiveness trial of the 4-session evidence-based YMHP intervention for young men who have sex with men (YMSM) of color ages 15-29 at two CBOs in New York City, compared to usual care.

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Key information

Age range

15 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bridging Access to Care, Brooklyn, New York, United States

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About this study

We will conduct a comparative effectiveness trial (CET) with two intensities of treatment to be offered following field-based HIV counseling and testing (C&T) - the young men's health project (YMHP) intervention and an enhanced "treatment as usual" (eTAU) condition involving HIV prevention services provided at two community based organizations (CBOs) to test their relative effectiveness in reducing substance use and sexual risk behavior among HIV-negative YMSM. In collaboration with two CBOs, our goals are to better understand substance use and sexual health-related outcomes among HIV-negative YMSM who are unlikely to be treatment seeking and to implement the YMHP intervention in a way that will maximize portability and scalability. Working together with our collaborators will help to address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce substance use and HIV infection among YMSM.

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
  • 15-29 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 sexually transmitted infection test result in the past 90 days.
  • Living in the New York City area
  • Able to communicate in English

Exclusion criteria

  • Serious cognitive or psychiatric impairments
  • ≥5 days of injection drug use in the past 90 days
  • Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)

Treatment and study plan

YMHP Intervention

Behavioral

Enhanced Treatment as Usual

Behavioral

Other names: eTau

Primary outcomes

  1. Illicit Drug Use Days

    Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month

    The self-reported number of illicit drug use days (not including marijuana) in the past 90 days

  2. Condomless Anal Sex Acts

    Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month

    The self-reported number of condomless anal sex acts with male partners in the past 90 days

  3. Marijuana Use Days

    Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month

    The self-reported number of marijuana use days in the past 90 days

Secondary outcomes

  1. Alcohol Use Days

    Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month

    The self-reported number of alcohol use days in the past 90 days

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: YMHP-CBO

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2018
Registry last updated
May 8, 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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