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

Hunter College of City University of New York

Status: Active, not recruiting

Conditions: Substance Use; HIV Infections

Treatments: Behavioral: Communication skills training video; Behavioral: Drug use module

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05000866

R01DA050508

Details and patient eligibility

About

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.

Enrollment: 484 patients

Sex: Male

Ages: 17 to 29 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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484 participants in 4 patient groups

CHTC as usual

No Intervention group

Description:

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

CHTC and communications skills training video

Active Comparator group

Description:

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

Treatment:

Behavioral: Communication skills training video

CHTC and substance use module

Active Comparator group

Description:

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

Treatment:

Behavioral: Drug use module

CHTC, communications skills training and substance use module

Active Comparator group

Description:

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

Treatment:

Behavioral: Drug use module

Behavioral: Communication skills training video