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

NCT05000866 | Active Not Recruiting DMC

• 1 other identifier: R01DA050508
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Use; HIV Infections

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Binge drinking

  12 months

• Syphilis infection

  12 months

• PrEP Uptake

  12 months

• PrEP adherence

  12 months

Study Arms (4)

CHTC as usual

NO INTERVENTION

Participants complete the standard Couples HIV Testing and Counseling session (CHTC).

CHTC and communications skills training video

ACTIVE COMPARATOR

Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together.

Behavioral: Communication skills training video

CHTC and substance use module

ACTIVE COMPARATOR

Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together.

Behavioral: Drug use module

CHTC, communications skills training and substance use module

ACTIVE COMPARATOR

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; Behavioral: Drug use module

Interventions

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.

CHTC and communications skills training video; CHTC, communications skills training and substance use module

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.

CHTC and substance use module; CHTC, communications skills training and substance use module

Eligibility Criteria

• Age: 17 Years - 29 Years
• Gender Eligibility Details: Both partners in the couple must identify as male.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• · 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

You may not qualify if:

• · Any signs of serious mental illness or cognitive deficit
• History of IPV with their main partner and safety concerns in the current relationship.

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Michigan: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Hunter College

New York, New York, 10018, United States

Location

Related Publications (1)

• 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.

  PMID: 34819058 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; HIV Infections

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 Record Dates

• First Submitted: April 7, 2021
• First Posted: August 11, 2021
• Study Start: October 13, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (2)