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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05000866
Acronym
4Us
Enrollment
484
Registered
2021-08-11
Start date
2021-10-13
Completion date
2027-01-31
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Substance Use

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.

Interventions

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.

BEHAVIORALDrug 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.

Sponsors

Hunter College of City University of New York
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Michigan
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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.

Eligibility

Sex/Gender
MALE
Age
17 Years to 29 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Drug use frequency12 monthsNumber 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 use12 monthsPositive urine screen for drug use assessed bi-annually
CAS with casual partners12 monthsNumber of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
Bacterial STI's12 monthsAny chlamydia or gonorrhea diagnosis assessed bi-annually

Secondary

MeasureTime frameDescription
Binge drinking12 monthsNumber of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
Syphilis infection12 monthsReactive RPR test assessed bi-annually
PrEP Uptake12 monthsself-reported receipt of a PrEP-prescription
PrEP adherence12 monthstaking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026