Clinical Trials Directory

Trials / Completed

CompletedNCT03125915

Addressing Substance Use Through CVCT

Addressing Substance Use Through Couples Voluntary Counseling and Testing (CVCT)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
140 (actual)
Sponsor
Hunter College of City University of New York · Academic / Other
Sex
Male
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

The proposed study developed and tested two adjunct components for use in Couples HIV Testing and Counseling (CHTC) with gay-male couples: a communication skills training video and a substance use agreement module. Phase I of the study involved the creation of intervention materials and Phase II was comprised of a small randomized controlled trial comparing the additive effects of the novel components to CHTC as usual.

Detailed description

Phase I: Utilizing formative qualitative data on the correspondence of sexual agreements, drug use, and sexual risk behavior, the study team created two adjunct intervention components: Communication skills training videos: The team produced a brief (20-minute) communication skills training video. The video includes 4 scenes in which a gay couple is depicted discussing HIV risk, sexual agreements, or drug use. The scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays the use of more effective interpersonal communication and a more adaptive outcome. Substance use agreement module: The team developed a structured activity to assist couples in clarifying their understanding and goals around substance use. The module includes the completion of a calendar detailing recent substance use and structured debriefing questions. Phase II: A randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of novel intervention components will be conducted. The trial involves 70 couples (n = 140 individuals). Half of the couples are randomized to complete the drug calendar (the other half do not). Half of the couples are randomized to view communication skills training videos, the other half do not. The result is four intervention conditions: 1. CHTC as usual 2. CHTC + communication skills training videos 3. CHTC + substance use module 4. CHTC + communication skills training videos + substance use calendar Participants complete a baseline assessment (either online or in person) prior to their intervention session. All intervention sessions are completed with both members of the couple together. Follow-up assessments are completed individually online at 1, 3, and 6 months post-intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCommunication skills training videoThis video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.
BEHAVIORALsubstance use moduleThis activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.
BEHAVIORALCouples HIV Testing and CounselingCHTC delivered as per the CDC protocol.

Timeline

Start date
2014-04-01
Primary completion
2018-02-01
Completion
2018-02-01
First posted
2017-04-24
Last updated
2021-04-15
Results posted
2020-02-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03125915. Inclusion in this directory is not an endorsement.