NCT03396367

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 14, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2024

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

October 29, 2025

Completed
Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

6 years

First QC Date

January 4, 2018

Results QC Date

June 11, 2025

Last Update Submit

October 16, 2025

Conditions

Adherence, MedicationRisk ReductionDrug UseSex, AnalHIV/AIDS

Keywords

RelationshipsYMSMHIV/AIDSPrEPDrug Use

Outcome Measures

Primary Outcomes (4)

  • Illicit Drug Use Days

    The self-reported number of illicit drug use days (not including marijuana) in the past 30 days

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

  • Cannabis Use Days

    The self-reported number of cannabis drug use days in the past 30 days

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

  • Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners

    The percentage of participants in each condition reporting sexual HIV transmission risk with a casual partner (any condomless sex with a casual partner in the absence of PrEP).

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

  • The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake

    The percentage participants in each condition who report having a current PrEP prescription at the time of follow-up.

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

Study Arms (2)

PARTNER Intervention

EXPERIMENTAL

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

Education Intervention

ACTIVE COMPARATOR

This intervention is a four-session intervention that discussed drug use and its effect on physiological social functioning.

Behavioral: Education Intervention

Interventions

PARTNERBEHAVIORAL

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.

PARTNER Intervention
Education InterventionBEHAVIORAL

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.

Education Intervention

Eligibility Criteria

Age18 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsBoth gender at birth and current self-identified gender must be male.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter College- City University of New York

New York, New York, 10018, United States

Location

Related Publications (2)

  • Parsons JT, Lelutiu-Weinberger C, Botsko M, Golub SA. A randomized controlled trial utilizing motivational interviewing to reduce HIV risk and drug use in young gay and bisexual men. J Consult Clin Psychol. 2014 Feb;82(1):9-18. doi: 10.1037/a0035311. Epub 2013 Dec 23.

    PMID: 24364800BACKGROUND

  • Starks TJ, Robles G, Pawson M, Jimenez RH, Gandhi M, Parsons JT, Millar BM. Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure Prophylaxis (Project PARTNER): Randomized Controlled Trial Protocol. JMIR Res Protoc. 2019 Jul 4;8(7):e13015. doi: 10.2196/13015.

    PMID: 31274114DERIVED

MeSH Terms

Conditions

Medication AdherenceRisk Reduction BehaviorSexual BehaviorAcquired Immunodeficiency Syndrome

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

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 of City University of New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 11, 2018

Study Start

February 14, 2018

Primary Completion

February 21, 2024

Study Completion

February 21, 2024

Last Updated

October 29, 2025

Results First Posted

October 29, 2025

Record last verified: 2025-10

Locations

US(1)