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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections; Substance Use
• Intervention / Treatment: Behavioral: Communication skills training video; Behavioral: Drug use module

• Study Type: Interventional
• Enrollment (Actual): 484
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New York
    • New York, New York, United States, 10018
      • Hunter College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug use frequency	Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments	12 months
Urine assay for drug use	Positive urine screen for drug use assessed bi-annually	12 months
CAS with casual partners	Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments	12 months
Bacterial STI's	Any chlamydia or gonorrhea diagnosis assessed bi-annually	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge drinking	Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview	12 months
Syphilis infection	Reactive RPR test assessed bi-annually	12 months
PrEP Uptake	self-reported receipt of a PrEP-prescription	12 months
PrEP adherence	taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments	12 months

Collaborators and Investigators

• Sponsor: Hunter College of City University of New York
• Collaborators: National Institute on Drug Abuse (NIDA); University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Chemically-Induced Disorders; HIV Infections; Substance-Related Disorders
• Other Study ID Numbers: R01DA050508 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No