Recruiting NCT06307977
Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Couples Health Project.
- Who it may be relevant to
- Registry conditions: Substance Use, HIV Infections. Basic parameters: 18 years — 55 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Behavioral Couples Health Project
A 3-session, couples motivational Interviewing drug use and HIV risk reduction intervention
Primary outcome measures
- Drug use Frequency [Time frame: 9 Months]
- Urine assay for drug use [Time frame: 9 Months]
- CAS with casual partners [Time frame: 9 Months]
Secondary outcome measures (3)
- Bacterial sexually transmitted infections [Time frame: 9 Months]
- Binge Drinking [Time frame: 9 Months]
- PrEP Uptake [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
- 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)
- Index participant must have engaged in TRB in the past 30 days- Defined as CAS with a casual partner, or a serodiscordant or non-monogamous main partner
- Live in the United States
- Speak and read English
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 3 centers
- Wayne State University — Detroit
- Hunter College — New York
- University of Virginia — Charlottesville
Publications
- Starks TJ, Hillesheim JR, Castiblanco J, Robles G, S Ingersoll K, Outlaw AY, Cain D. A protocol for a randomized controlled trial of couples motivational interviewing to reduce drug use and HIV transmission risk among male couples in the US: the Couples Health Project. BMC Public Health. 2024 Nov 19;24(1):3216. doi: 10.1186/s12889-024-20719-y. PMID 39563247
Identifiers
NCT: NCT06307977 · R01DA059272