Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color (YMHP-CBO)
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ClinicalTrials.gov Identifier: NCT03488914
Recruitment Status :
Active, not recruiting
First Posted : April 5, 2018
Last Update Posted : February 10, 2021
Hunter College of City University of New York
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Tyrel Starks, Hunter College of City University of New York
This study will conduct an effectiveness trial of the 4-session evidence-based YMHP intervention for YMSM of color ages 15-29 at two CBOs in New York City, compared to usual care.
Condition or disease
Substance UseSexual Risk
Behavioral: YMHP InterventionBehavioral: Enhanced Treatment as Usual
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 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 MYMSM. In collaboration with two CBOs, our goals are to better understand substance use and sexual health-related outcomes among HIV-negative MYMSM 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 MYMSM.
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Layout table for eligibility information
Ages Eligible for Study:
15 Years to 29 Years (Child, Adult)
Sexes Eligible for Study:
Gender Based Eligibility:
Accepts Healthy Volunteers:
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 CAS in the past 90 days, or a positive STI test result in the past 90 days.
Living in the New York City area
Able to communicate in English
Serious cognitive or psychiatric impairments
≥5 days of IDU drug use in the past 90 days
Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Data sharing with scientific and health service community: We will have compiled structured de-identified datasets and can make them available for additional/secondary data analyses. It is our explicit intention that these data be readily accessible. We will collaborate with and make our data available to other researchers for additional/secondary analyses. Formal data sharing agreements will be developed to guide and encourage further data mining of the proposed datasets for various purposes.
Statistical Analysis Plan (SAP)
As per NIH policy
The dissemination of any and all data collected under the NIH data sharing agreement will be released: a) In a timely manner following the time line of the project provide; and b) To the broader community, in accordance with NIH guidelines. Active dissemination to collaborators, community groups and through peer-reviewed articles will facilitate access to the data.