NCT03488914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 8, 2024

Completed
Last Updated

May 8, 2024

Status Verified

April 1, 2024

Enrollment Period

4.9 years

First QC Date

March 29, 2018

Results QC Date

November 25, 2021

Last Update Submit

April 13, 2024

Conditions

Substance UseSexual Risk

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Alcohol Use Days

    Baseline, 3-Month, 6-Month, 9-Month, 12-Month, 15-Month

Study Arms (2)

Intervention

OTHER

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

Enhanced Treatment as Usual

OTHER

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

Interventions

YMHP InterventionBEHAVIORAL
Intervention
Enhanced Treatment as UsualBEHAVIORAL
Also known as: eTau
Enhanced Treatment as Usual

Eligibility Criteria

Age15 Years - 29 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV-negative test result from the past 90 days
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bridging Access to Care

Brooklyn, New York, 11226, United States

Location

BOOM!Health

The Bronx, New York, 10458, United States

Location

Related Publications (3)

  • 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.

    PMID: 36273221DERIVED

  • 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.

    PMID: 35394598DERIVED

  • 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.

    PMID: 31115346DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Limitations and Caveats

Enrollment was delayed substantially by implementation challenges early in the trial. Due to the COVID pandemic, enrollment closed early. As a result, the sample enrolled was less than half of the original proposal.

Results Point of Contact

Title
Dr. Tyrel Starks
Organization
Hunter College
tstarks@hunter.cuny.edu
212-772-5550

Study Officials

  • Tyrel J Starks, PhD

    Hunter College, CUNY

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomization to YMHP or enhanced Treatment as Usual (eTAU)
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 5, 2018

Study Start

June 15, 2016

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

May 8, 2024

Results First Posted

May 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.

Locations

US(2)