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Prevention and Risk: Treatment With a New Emphasis on Relationships (PARTNER)

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ClinicalTrials.gov Identifier: NCT03396367
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Tyrel Starks, Hunter College of City University of New York

Brief Summary:
This research examines the efficacy of an individually-delivered intervention tailored for YMSM in relationships. The intervention - termed PARTNER - utilizes a brief (4 session) motivational interviewing format to target Pre-Exposure Prophylaxis (PrEP) uptake/adherence, HIV transmission risk behavior, and associated drug use.

Condition or disease Intervention/treatment Phase
Adherence, Medication Risk Reduction Drug Use Sex, Anal HIV/AIDS Behavioral: PARTNER Behavioral: Education Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intervention to Reduce Drug Use and HIV Incidence Among High PrEP Priority Partnered YMSM
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: PARTNER Intervention
This intervention is a four-session intervention designed to increase PrEP uptake, increase PrEP adherence, and reduce drug use and HIV transmission risk behaviors of individuals in relationships.
Behavioral: PARTNER
The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.

Active Comparator: Education Intervention
This intervention is a four-session intervention that discussed drug use and its effect on physiological social functioning.
Behavioral: Education Intervention
The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.




Primary Outcome Measures :
  1. Number of drug use instances [ Time Frame: 12 Months ]
    Self Report

  2. Positive drug assays [ Time Frame: 12 Months ]
    Drug test via fingernail assay

  3. Pre-Exposure Prophylaxis (PrEP) uptake [ Time Frame: 12 Month ]
    Self Report

  4. Pre-Exposure Prophylaxis (PrEP) adherence [ Time Frame: 12 Months ]
    Dried blood spot (DBS) via Western Blot analysis

  5. Number of HIV transmission risk events [ Time Frame: 12 Months ]
    Self-report of condomless anal sex (CAS)

  6. Positive sexually transmitted infection (STI) test [ Time Frame: 12 Months ]
    STI test via urinalysis and rectal swab


Secondary Outcome Measures :
  1. Pre-Exposure Prophylaxis (PrEP) adherence [ Time Frame: 12 Months ]
    Via fingernail assay

  2. Effectiveness of intervention implementation [ Time Frame: 12 Months ]
    Qualitative analysis of intervention feedback interviews



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Both gender at birth and current self-identified gender must be male.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 29 years of age (inclusive);
  • Main partner must be aged 18 or older.
  • Must be in a main partner relationship with another male (duration ≥ 1 months);
  • HIV-negative serostatus (confirmed by rapid test);
  • Recent (past 30 day) use of at least one of the substances identified as most commonly used by YMSM (marijuana, cocaine, methamphetamine, heroin or other opiates, MDMA, psychedelics, GHB, and/or ketamine);
  • Sexual behavior meeting CDC criteria for PrEP candidacy (TRB with a casual partner in the past 30 days or TRB with a non-monogamous or serodiscordant main partner).
  • Participants must reside in the NYC metro area
  • Ability to communicate in English

Exclusion Criteria:

  • Unstable, serious psychiatric symptoms (assessed by the Psychotic Disorder subsection of the Structured Clinical Interview for DSM-IV);
  • Current suicidal/homicidal ideation;
  • Evidence of gross cognitive impairment (a score of <24 on the mini-mental state examination)
  • A history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship in which participants report not currently feeling "safe" in their relationship and/or coerced to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396367


Contacts
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Contact: Tyrel J Starks, PhD 212-206-7919 ext 934 tstarks@hunter.cuny.edu
Contact: Rodrigo Valles, PhD 212-206-7919 ext 925 rvalles@chestnyc.org

Locations
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United States, New York
Center for HIV Educational Studies and Training; Hunter College Recruiting
New York, New York, United States, 10018
Contact: Rodrigo Valles, PhD    212-206-7919 ext 925    rvalles@chestnyc.org   
Principal Investigator: Tyrel J Starks, PhD         
Sub-Investigator: Jeffrey T Parsons, PhD         
Sponsors and Collaborators
Hunter College of City University of New York
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Tyrel J Starks, PhD Hunter College of City University of New York

Publications:
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Responsible Party: Tyrel Starks, Associate Professor of Psychology, Hunter College of City University of New York
ClinicalTrials.gov Identifier: NCT03396367     History of Changes
Other Study ID Numbers: R01DA045613 ( U.S. NIH Grant/Contract )
R01DA045613 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tyrel Starks, Hunter College of City University of New York:
Relationships
YMSM
HIV/AIDS
PrEP
Drug Use