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

Primary Purpose

Substance Use, Sexual Risk

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
YMHP Intervention
Enhanced Treatment as Usual
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

15 Years - 29 Years (Child, Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • BOOM!Health
  • Bridging Access to Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention

Enhanced Treatment as Usual

Arm Description

Outcomes

Primary Outcome Measures

Days of Drug Use
Condomless Anal Sex Acts
STI

Secondary Outcome Measures

PrEP Uptake

Full Information

First Posted
March 29, 2018
Last Updated
February 9, 2021
Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03488914
Brief Title
Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
Acronym
YMHP-CBO
Official Title
Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2016 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Sexual Risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Randomization to YMHP or enhanced Treatment as Usual (eTAU)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Title
Enhanced Treatment as Usual
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
YMHP Intervention
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment as Usual
Other Intervention Name(s)
eTau
Primary Outcome Measure Information:
Title
Days of Drug Use
Time Frame
Past 3 months
Title
Condomless Anal Sex Acts
Time Frame
Past 3 months
Title
STI
Time Frame
Past 3 months
Secondary Outcome Measure Information:
Title
PrEP Uptake
Time Frame
Past 3 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyrel J Starks, PhD
Organizational Affiliation
Hunter College, CUNY
Official's Role
Principal Investigator
Facility Information:
Facility Name
BOOM!Health
City
Bronx
State/Province
New York
ZIP/Postal Code
10458
Country
United States
Facility Name
Bridging Access to Care
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
As per NIH policy
IPD Sharing 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.
Citations:
PubMed Identifier
36273221
Citation
Coyle K, Carcone AI, Butame S, Pooler-Burgess M, Chang J, Naar S. Adapting the self-assessment of contextual fit scale for implementation of evidence-based practices in adolescent HIV settings. Implement Sci Commun. 2022 Oct 22;3(1):115. doi: 10.1186/s43058-022-00349-4.
Results Reference
derived
PubMed Identifier
35394598
Citation
Bradford-Rogers J, Lopez-Matos J, Cain D, Lopez D, Starks TJ. Comparing the Efficiency of Online and Field-Based Outreach for the Recruitment of Black and Latino Sexual Minority Men into an HIV Prevention Implementation Trial. Prev Sci. 2022 Aug;23(6):900-906. doi: 10.1007/s11121-022-01367-3. Epub 2022 Apr 8.
Results Reference
derived
PubMed Identifier
31115346
Citation
Parsons JT, Starks T, Gurung S, Cain D, Marmo J, Naar S. Clinic-Based Delivery of the Young Men's Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2019 May 21;8(5):e11184. doi: 10.2196/11184.
Results Reference
derived

Learn more about this trial

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

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