Young Men's Health Project Targeting HIV Risk Reduction and Substance Abuse
YMHP
Comparative Effectiveness Trial of Clinic-Based Delivery of an HIV Risk Reduction Intervention for Young Men Who Have Sex With Men (YMSM)
1 other identifier
interventional
83
1 country
3
Brief Summary
YMHP is a counseling intervention program for which the goals are to better understand HIV-prevention focused self-management behaviors among HIV-negative YMSM, and to study the implementation of YMHP to improve portability and scalability. The clinic sites will help investigators to assess and address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce HIV infection among YMSM that reflects the complexities of real world adolescent HIV clinics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Oct 2018
Typical duration for not_applicable hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedStudy Start
First participant enrolled
October 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedResults Posted
Study results publicly available
September 3, 2024
CompletedSeptember 3, 2024
April 1, 2024
3.7 years
April 6, 2018
May 30, 2023
April 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Illicit Drug Use Days
The self-reported number of illicit drug use days (not including marijuana) in the past 30 days
baseline, 3 months, 6 months, 9 months, 12 months
Condomless Anal Sex Acts
The self-reported number of condomless anal sex acts with male partners in the last 30 days prior to assessment point.
baseline, 3 months, 6 months, 9 months, 12 months
Marijuana Use Days
The self-reported number of marijuana use days in the past 30 days prior to assessment point.
baseline, 3 months, 6 months, 9 months, 12 months
Secondary Outcomes (1)
Alcohol Use Days
baseline, 3 months, 6 months, 9 months, 12 months
Study Arms (4)
Clinic-based Delivery
ACTIVE COMPARATORParticipants will receive the intervention in person following HIV counseling and testing. The intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Remote Delivery
ACTIVE COMPARATORParticipants will receive the intervention by remote delivery following HIV counseling and testing. Just as the clinic-based participants, he intervention involves completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis (PrEP) information and navigation services to interested participants. This arm is closed to enrollment.
Multi-modal Delivery
ACTIVE COMPARATORA 4 session MI intervention. Session 1 is always delivered in person immediately after baseline. Session 2-4 can be delivered in person or remotely based upon youth preference. This arm is open to enrollment as of 11/15/2019.
Treatment as Usual
NO INTERVENTIONTreatment as usual control = individual HIV testing with referrals and link age to care as provided by the sites under routine circumstances. This arm is open to enrollment as of 11/15/2019.
Interventions
A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
Eligibility Criteria
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
- ≥ 3 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 STI test result in the past 90 days.
- Able to communicate in English
You may not qualify if:
- Serious cognitive or psychiatric impairments
- Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Wayne State University
Detroit, Michigan, 48202, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sylvie Naar, PhD; Distinguished Endowed Professor
- Organization
- Florida State University
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie Naar, PhD
Florida State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 6, 2018
First Posted
July 5, 2018
Study Start
October 4, 2018
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
September 3, 2024
Results First Posted
September 3, 2024
Record last verified: 2024-04