Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-55
SponsorHunter College of City University of New York

About this trial

This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Have a main partner who is another cisgender male and have been in a relationship for 3 month or longer

Index participant must be between 18 and 55; Main partner can be any age 18 and older

One participant must be HIV negative (as confirmed by rapid test)

One participant must have used at least 1 drug in the past 30 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB, amyl nitrite)

Disqualifiers

Any signs of serious mental illness or cognitive deficit

Current suicidal/homicidal ideations

History of IPV with their main partner and safety concerns in the current relationship.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Couples Health Project

    Behavioral

    A 3-session, couples motivational Interviewing drug use and HIV risk reduction intervention

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: No Intervention: CHTC as usualNo intervention 0 interventions
Group B: Behavioral: Couples Health ProjectActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Drug use Frequency

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

Time frame
9 Months
2

Urine assay for drug use

Positive urine screen for drug use assessed bi-annually

Time frame
9 Months
3

CAS with casual partners

Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments in the absence of adequate PrEP coverage

Time frame
9 Months

Secondary outcomes

1

Bacterial sexually transmitted infections

Any chlamydia or gonorrhea diagnosis

Time frame
9 Months
2

Binge Drinking

Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview

Time frame
9 Months
3

PrEP Uptake

self-reported receipt of a PrEP-prescription

Time frame
9 months

Other outcomes

Sponsors and contacts

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Hunter College of City University of New York

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator