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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

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.

Condition or disease Intervention/treatment Phase
Substance Use HIV Infections Behavioral: Communication skills training video Behavioral: Drug use module Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
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
Official Title: Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples
Estimated Study Start Date : August 23, 2021
Estimated Primary Completion Date : April 15, 2025
Estimated Study Completion Date : April 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
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.

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.
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.

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.
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.




Primary Outcome Measures :
  1. 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

  2. Urine assay for drug use [ Time Frame: 12 months ]
    Positive urine screen for drug use assessed bi-annually

  3. 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

  4. Bacterial STI's [ Time Frame: 12 months ]
    Any chlamydia or gonorrhea diagnosis assessed bi-annually


Secondary Outcome Measures :
  1. 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

  2. Syphilis infection [ Time Frame: 12 months ]
    Reactive RPR test assessed bi-annually

  3. PrEP Uptake [ Time Frame: 12 months ]
    self-reported receipt of a PrEP-prescription

  4. PrEP adherence [ Time Frame: 12 months ]
    taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Both partners in the couple must identify as male.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05000866


Contacts
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Contact: Tyrel J Starks 212-206-7919 tstarks@hunter.cuny.edu
Contact: Christine Cowles 212-206-7919 ccowles@hunter.cuny.edu

Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Contact: Robert Stephenson, PhD    734-615-0149    rbsteph@umich.edu   
United States, New York
Hunter College
New York, New York, United States, 10018
Contact: Christine Cowles, MPH    212-206-7919    ccowles@hunter.cuny.edu   
Principal Investigator: Tyrel J Starks, PhD         
Sponsors and Collaborators
Hunter College of City University of New York
National Institute on Drug Abuse (NIDA)
University of Michigan
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Responsible Party: Tyrel Starks, Associate Professor, Hunter College of City University of New York
ClinicalTrials.gov Identifier: NCT05000866    
Other Study ID Numbers: R01DA050508 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders