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

NCT ID: NCT03488914

Last Updated: 2024-05-08

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-15

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Substance Use Sexual Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Randomization to YMHP or enhanced Treatment as Usual (eTAU)

Study Groups

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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.

Group Type OTHER

YMHP Intervention

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Enhanced Treatment as Usual

Intervention Type BEHAVIORAL

Interventions

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YMHP Intervention

Intervention Type BEHAVIORAL

Enhanced Treatment as Usual

Intervention Type BEHAVIORAL

Other Intervention Names

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eTau

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Hunter College of City University of New York

OTHER

Sponsor Role lead

Responsible Party

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Tyrel Starks

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tyrel J Starks, PhD

Role: PRINCIPAL_INVESTIGATOR

Hunter College, CUNY

Locations

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Bridging Access to Care

Brooklyn, New York, United States

Site Status

BOOM!Health

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36273221 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35394598 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31115346 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

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Other Identifiers

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R01DA041262

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA041262

Identifier Type: NIH

Identifier Source: org_study_id

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