Clinical trial NCT05000866: Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
Official title: Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
HIV Infections
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Michigan
First posted: 2021-08-11
Enrollment: 480
Sex: MALE
Minimum age (years): 17
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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 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.

Primary outcomes:
measure: Drug use frequency
timeFrame: 12 months
measure: Urine assay for drug use
timeFrame: 12 months
measure: CAS with casual partners
timeFrame: 12 months
measure: Bacterial STI's
timeFrame: 12 months
Secondary outcomes:
measure: Binge drinking
timeFrame: 12 months
measure: Syphilis infection
timeFrame: 12 months
measure: PrEP Uptake
timeFrame: 12 months
measure: PrEP adherence
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Hunter College
state: New York
Study officials:
References:
citation: Starks TJ, D Kyre K, B Cowles C, Castiblanco J, Washington C, N Parker J, M Kahle E, Stephenson R. A full-factorial randomized controlled trial of adjunct couples HIV testing and counseling components addressing drug use and communication skills among sexual minority male couples. BMC Public Health. 2021 Nov 24;21(1):2158. doi: 10.1186/s12889-021-12208-3.