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Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples (4Us)

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ClinicalTrials.gov Identifier: NCT05000866
Recruitment Status : Not yet recruiting
First Posted : August 11, 2021
Last Update Posted : August 11, 2021
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Michigan
Information provided by (Responsible Party):
Tyrel Starks, Hunter College of City University of New York

Tracking Information
First Submitted Date  ICMJE April 7, 2021
First Posted Date  ICMJE August 11, 2021
Last Update Posted Date August 11, 2021
Estimated Study Start Date  ICMJE August 23, 2021
Estimated Primary Completion Date April 15, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2021)
  • Drug use frequency [ Time Frame: 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 [ Time Frame: 12 months ]
    Positive urine screen for drug use assessed bi-annually
  • CAS with casual partners [ Time Frame: 12 months ]
    Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
  • Bacterial STI's [ Time Frame: 12 months ]
    Any chlamydia or gonorrhea diagnosis assessed bi-annually
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2021)
  • Binge drinking [ Time Frame: 12 months ]
    Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
  • Syphilis infection [ Time Frame: 12 months ]
    Reactive RPR test assessed bi-annually
  • PrEP Uptake [ Time Frame: 12 months ]
    self-reported receipt of a PrEP-prescription
  • PrEP adherence [ Time Frame: 12 months ]
    taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
Official Title  ICMJE Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Substance Use
  • HIV Infections
Intervention  ICMJE
  • Behavioral: Communication skills training video
    The communication skills training video component is designed to be self-delivered. Four couples are depicted in separate scenes discussing HIV testing, drug use, sexual agreements, and drug use during sex. Each scene is viewed twice. In the initial viewing, the couple in the video makes one or more communication errors. The scene is subsequently viewed a second time and the couple utilizes more effective communication skills, resulting in a more adaptive resolution. Each scene is introduced by a narrator who points out communication errors and orients viewers to skills utilized in adaptive versions of each scene.
  • Behavioral: Drug use module
    The substance use module is administered after step 5 of CHTC and prior to the delivery of rapid HIV-test results. The couple was first asked to fill in a calendar for the past 30 days, indicating each day on which either member used drugs or consumed alcohol. Completion of the calendar is done through an ACCESS database to facilitate remote intervention delivery. After completion of the calendar, the HIV tester asked a series of debriefing questions designed to elicit the couples' perspective on their use, establish the couple's goals and limits for drug use, and make plans to achieve these goals.
Study Arms  ICMJE
  • No Intervention: CHTC as usual
    Participants complete the standard Couples HIV Testing and Counseling session (CHTC).
  • Active Comparator: CHTC and communications skills training video
    Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together.
    Intervention: Behavioral: Communication skills training video
  • Active Comparator: CHTC and substance use module
    Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together.
    Intervention: Behavioral: Drug use module
  • Active Comparator: CHTC, communications skills training and substance 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.
    Interventions:
    • Behavioral: Communication skills training video
    • Behavioral: Drug use module
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2021)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2025
Estimated Primary Completion Date April 15, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Both partners in the couple must identify as male.
Ages  ICMJE 17 Years to 29 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tyrel J Starks 212-206-7919 tstarks@hunter.cuny.edu
Contact: Christine Cowles 212-206-7919 ccowles@hunter.cuny.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05000866
Other Study ID Numbers  ICMJE R01DA050508( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tyrel Starks, Hunter College of City University of New York
Study Sponsor  ICMJE Hunter College of City University of New York
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • University of Michigan
Investigators  ICMJE Not Provided
PRS Account Hunter College of City University of New York
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP