Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
- Conditions
- Substance UseHIV Infections
- Interventions
- Behavioral: Communication skills training videoBehavioral: Drug use module
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 480
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· Have a main partner who is another male and have been in a relationship for 3 month or longer
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One participant must be between 17 and 29; Main partner can be any age above 17.
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One participant must be HIV negative (as confirmed by rapid test)
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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)
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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
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Live in the NYC or Detroit metropolitan area
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Speak English
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· 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
- Arm && Interventions
Group Intervention Description CHTC and communications skills training video Communication skills training video Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together. CHTC, communications skills training and substance use module Drug use module Participants complete the standard Couples HIV Testing and Counseling session and watch a communication skills training video and complete a substance use module together. CHTC and substance use module Drug use module Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together. CHTC, communications skills training and substance use module Communication skills training video Participants complete the standard Couples HIV Testing and Counseling session and watch a communication skills training video and complete a substance use module together.
- 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)
Hunter College
🇺🇸New York, New York, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States