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

Not Applicable

Recruiting

• Conditions: Substance Use; HIV Infections

• Registration Number: NCT05000866
• Lead Sponsor: Hunter College of City University of New York

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-11
• Study Start: 2021-10-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Drug use frequency	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	12 months	Positive urine screen for drug use assessed bi-annually
CAS with casual partners	12 months	Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
Bacterial STI's	12 months	Any chlamydia or gonorrhea diagnosis assessed bi-annually

Secondary Outcome Measures

Name	Time	Method
PrEP Uptake	12 months	self-reported receipt of a PrEP-prescription
Binge drinking	12 months	Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
Syphilis infection	12 months	Reactive RPR test assessed bi-annually
PrEP adherence	12 months	taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Hunter College; 🇺🇸 New York, New York, United States