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NCT Number: NCT05000866

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Substance Use Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

17 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Communication skills training video

Behavioral

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.

Drug use module

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Michigan

Registry information

Acronym: 4Us

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2021
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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