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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Notify MeKey information
Conditions
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
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
Enhanced Treatment as Usual
BehavioralOther names: eTau
Primary outcomes
-
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
-
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
-
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
-
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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