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

N/AActive Not RecruitingNCT05000866

Hunter College of City University of New York484 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

484

Conditions

Substance Use HIV Infections

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.

Drug use moduleBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 17 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

University of Michigan

Ann Arbor, Michigan, United States

Hunter College

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

Urine assay for drug use

Positive urine screen for drug use assessed bi-annually

Time frame: 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

Time frame: 12 months

Bacterial STI's

Any chlamydia or gonorrhea diagnosis assessed bi-annually

Time frame: 12 months

Secondary Outcomes

Binge drinking

Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview

Time frame: 12 months

Syphilis infection

Reactive RPR test assessed bi-annually

Time frame: 12 months

PrEP Uptake

self-reported receipt of a PrEP-prescription

Time frame: 12 months

PrEP adherence

taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments

Time frame: 12 months