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Clinical Trials/NCT05000866
NCT05000866
Active, Not Recruiting
N/A

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

Hunter College of City University of New York2 sites in 1 country484 target enrollmentOctober 13, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Substance Use
Sponsor
Hunter College of City University of New York
Enrollment
484
Locations
2
Primary Endpoint
Drug use frequency
Status
Active, Not Recruiting
Last Updated
4 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 13, 2021
End Date
May 31, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Factorial
Sex
Male

Investigators

Sponsor
Hunter College of City University of New York
Responsible Party
Principal Investigator
Principal Investigator

Tyrel Starks

Professor

Hunter College of City University of New York

Eligibility Criteria

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
  • 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.

Outcomes

Primary Outcomes

Drug use frequency

Time Frame: 12 months

Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments

Urine assay for drug use

Time Frame: 12 months

Positive urine screen for drug use assessed bi-annually

CAS with casual partners

Time Frame: 12 months

Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments

Bacterial STI's

Time Frame: 12 months

Any chlamydia or gonorrhea diagnosis assessed bi-annually

Secondary Outcomes

  • PrEP Uptake(12 months)
  • PrEP adherence(12 months)
  • Binge drinking(12 months)
  • Syphilis infection(12 months)

Study Sites (2)

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