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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03488914
Recruitment Status : Active, not recruiting
First Posted : April 5, 2018
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Tyrel Starks, 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 YMSM of color ages 15-29 at two CBOs in New York City, compared to usual care.

Condition or disease Intervention/treatment Phase
Substance Use Sexual Risk Behavioral: YMHP Intervention Behavioral: Enhanced Treatment as Usual Not Applicable

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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Randomization to YMHP or enhanced Treatment as Usual (eTAU)
Primary Purpose: Prevention
Official Title: Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
Actual Study Start Date : June 15, 2016
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Intervention Behavioral: YMHP Intervention
Enhanced Treatment as Usual Behavioral: Enhanced Treatment as Usual
Other Name: eTau




Primary Outcome Measures :
  1. Days of Drug Use [ Time Frame: Past 3 months ]
  2. Condomless Anal Sex Acts [ Time Frame: Past 3 months ]
  3. STI [ Time Frame: Past 3 months ]

Secondary Outcome Measures :
  1. PrEP Uptake [ Time Frame: Past 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488914


Locations
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United States, New York
BOOM!Health
Bronx, New York, United States, 10458
Bridging Access to Care
Brooklyn, New York, United States, 11226
Sponsors and Collaborators
Hunter College of City University of New York
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Tyrel J Starks, PhD Hunter College, CUNY
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tyrel Starks, Associate Professor, Hunter College of City University of New York
ClinicalTrials.gov Identifier: NCT03488914    
Other Study ID Numbers: R01DA041262 ( U.S. NIH Grant/Contract )
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: As per NIH policy
Access Criteria: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No