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Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples | Clinical Trials | Clareo Health

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Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples

NCT05000866•Hunter College of City University of New York

View on ClinicalTrials.gov

Summary

This study utilizes a randomized controlled trial design to evaluate the efficacy of two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.

Eligibility

Age

17 - 29 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•· Have a main partner who is another male and have been in a relationship for 3 month or longer
•* One participant must be between 17 and 29; Main partner can be any age above 17.
•* One participant must be HIV negative (as confirmed by rapid test)
•* One participant must have used at least 1 drug in the past 90 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB)
•* One participant must have engaged in Transmission Risk Behavior (TRB) in the past 90 days
•o Defined as Condom-less Anal Sex (CAS) with a casual partner and/or CAS with a non-monogamous or serodiscordant main partner
•* Live in the NYC or Detroit metropolitan area
•* Speak English

Exclusion Criteria

•· Any signs of serious mental illness or cognitive deficit
•* History of IPV with their main partner and safety concerns in the current relationship.

Locations (2)

University of Michigan

Ann Arbor, Michigan, United States

Hunter College

New York, New York, United States

Key Dates

Start Date

October 13, 2021

Primary Completion Date

May 31, 2026

Completion Date

May 31, 2026

Last Updated

December 16, 2025

Enrollment

484

ACTUAL participants

Conditions

Substance UseHIV Infections

Interventions

Communication skills training video

BEHAVIORAL

Drug use module

BEHAVIORAL

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

NCT04197921

Opioid-use DisorderSubstance Use Disorders

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RECRUITINGPHASE4

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

NCT07199335

HIVSubstance Use Disorder (SUD)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples

Inclusion Criteria

Exclusion Criteria

Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

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