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NCT03488914 Clinical Trial

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

Substance Use Clinical Trial

— YMHP-CBO  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03488914
Other study ID # R01DA041262
Secondary ID R01DA041262
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2016
Est. completion date April 30, 2021

Study information
Verified date April 2024
Source Hunter College of City University of New York
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 15 Years to 29 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• YMHP Intervention

• Enhanced Treatment as Usual

Locations
Country Name City State
United States BOOM!Health Bronx New York
United States Bridging Access to Care Brooklyn New York

Sponsors (2)
Lead Sponsor Collaborator
Hunter College of City University of New York National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Illicit Drug Use Days The self-reported number of illicit drug use days (not including marijuana) in the past 90 days Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Primary Condomless Anal Sex Acts The self-reported number of condomless anal sex acts with male partners in the past 90 days Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Primary Marijuana Use Days The self-reported number of marijuana use days in the past 90 days Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Secondary Alcohol Use Days The self-reported number of alcohol use days in the past 90 days Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
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