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

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.

Study Overview

• Status: Completed
• Conditions: Substance Use; Sexual Risk
• Intervention / Treatment: Behavioral: Enhanced Treatment as Usual; Behavioral: YMHP Intervention

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10458
      • Boom!Health
    • Brooklyn, New York, United States, 11226
      • Bridging Access to Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention; The YMHP intervention is a 4 session Motivational Interviewing (MI) intervention. In session 1, youth will choose which behavior to discuss first (substance use or sexual risk behavior), and the Health Educator counselor will elicit the client's view of the problem using standard MI techniques, building motivation for change by eliciting and reinforcing change talk, and clarifying the youth's own personal goals for maintaining their sexual health/considering changes in their substance use. The second session follows the same format for the second target behavior. In the subsequent two sessions, the counselor will discuss Pre-exposure Prophylaxis (PrEP) uptake as part of a change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.	Behavioral: YMHP Intervention
Other: Enhanced Treatment as Usual; The Enhanced Treatment as Usual arm involves referring youth to standard of care services available at the community based organization for substance use and sexual health. This includes available services for Pre-exposure prophylaxis.	Behavioral: Enhanced Treatment as Usual; Other Names: eTau

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illicit Drug Use Days	The self-reported number of illicit drug use days (not including marijuana) in the past 90 days	Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Condomless Anal Sex Acts	The self-reported number of condomless anal sex acts with male partners in the past 90 days	Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Marijuana Use Days	The self-reported number of marijuana use days in the past 90 days	Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hunter College of City University of New York
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Tyrel J Starks, PhD, Hunter College, CUNY

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2016
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: R01DA041262 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No