Clinical trial NCT03488914: Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
Official title: Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Sexual Risk
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-04-05
Enrollment: 86
Sex: MALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

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 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)

Primary outcomes:
measure: Illicit Drug Use Days
timeFrame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
measure: Condomless Anal Sex Acts
timeFrame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
measure: Marijuana Use Days
timeFrame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Secondary outcomes:
measure: Alcohol Use Days
timeFrame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month
Other outcomes:
Locations:
city: Bronx
country: United States
facility: BOOM!Health
state: New York
city: Brooklyn
country: United States
facility: Bridging Access to Care
state: New York
Study officials:
affiliation: Hunter College, CUNY
name: Tyrel J Starks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.