Addressing Substance Use Through CVCT

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03125915
Study type	Interventional
Source	Hunter College of City University of New York
Contact
Status	Completed
Phase	N/A
Start date	April 1, 2014
Completion date	February 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05468879` - Bioequivalence Study of 3 mg Glimepiride Tablet in Indonesia Healthy Subjects	N/A
Not yet recruiting	`NCT06395129` - Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
Completed	`NCT02293057` - Gender-Responsive Drug Use Treatment for Juvenile Justice Girls	N/A
Completed	`NCT01941108` - Technology-Enhanced Peer Navigation to Improve IDUs' Engagement in HIV Care	N/A
Completed	`NCT01380613` - Neighborhoods, Networks, Depression, and HIV Risk	Phase 2
Withdrawn	`NCT00914719` - Alcohol Use and Sexual Risk: An Intervention	N/A
Recruiting	`NCT03671629` - Pharmacist Intervention to Reduce Drug-related Readmissions Among the Elderly	N/A
Completed	`NCT03290391` - Linking Infectious and Narcology Care-Part II	Phase 4
Completed	`NCT04008927` - A Community-based Intervention Among Active Drug Users in Montpellier	N/A
Completed	`NCT03627546` - HCV Seek, Test and Rapid Treatment for Young PWID	N/A
Recruiting	`NCT05380765` - Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents	N/A
Not yet recruiting	`NCT03967262` - Secondary Prevention and Recidivism Reduction in Trauma Patients	N/A
Completed	`NCT03079856` - Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER	N/A
Completed	`NCT03855410` - Preventing Cigarette Use Among Urban Youth Via an M-Health Primary Care Preventive Intervention	N/A
Terminated	`NCT02457949` - The Impact of Alternative Social Assistance Disbursement on Drug-related Harm	N/A
Completed	`NCT06238154` - Flurbiprofen Tablet vs Spray In Oral Soft Tissue Wounds	Phase 4
Terminated	`NCT04436055` - Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
Recruiting	`NCT04717856` - Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA	N/A
Completed	`NCT00249496` - Employment-based Reinforcement to Motivate Drug Abstinence in the Treatment of Drug Addiction. - 1	N/A
Recruiting	`NCT05597865` - Assessing the Feasibility of Economic Approaches to Prevent Substance Abuse Among Adolescents	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.