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

Not Applicable

Completed

• Conditions: Sexual Risk; Substance Use

• Registration Number: NCT03488914
• Lead Sponsor: Hunter College of City University of New York

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-06-15
• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-05
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Results First Submitted: 2021-11-25
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-13
• Last Update Submitted: 2024-04-13
• Results First Posted: 2024-05-08
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Condomless Anal Sex Acts	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
Marijuana Use Days	Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month	The self-reported number of marijuana use days in the past 90 days
Illicit Drug Use Days	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

Secondary Outcome Measures

Name	Time	Method
Alcohol Use Days	Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month	The self-reported number of alcohol use days in the past 90 days

Trial Locations

Locations (2)

BOOM!Health; 🇺🇸 Bronx, New York, United States

Bridging Access to Care; 🇺🇸 Brooklyn, New York, United States