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Clinical Trials/NCT03125915
NCT03125915
Completed
Not Applicable

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

Hunter College of City University of New York1 site in 1 country140 target enrollmentApril 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sex, Unsafe
Sponsor
Hunter College of City University of New York
Enrollment
140
Locations
1
Primary Endpoint
Proportion of Respondents Reporting Any Drug Use
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2014
End Date
February 1, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Male

Investigators

Sponsor
Hunter College of City University of New York
Responsible Party
Principal Investigator
Principal Investigator

Tyrel Starks

Associate Professor

Hunter College of City University of New York

Eligibility Criteria

Inclusion Criteria

  • Both members of the couple:
  • are born male and current male gender identity;
  • identify as gay, bisexual or same-sex attracted;
  • read English at 8th grade level or better;
  • have access to the Internet;
  • agree to audio and video recording of intervention sessions;
  • At least one member of the couple:
  • reports the use of any drug listed on the DAST-10 in the previous 30 days.
  • s identified as HIV negative during screening and baseline assessments.
  • has been together for at least 3 months;

Exclusion Criteria

  • At baseline either member of the couple reports intimate partner violence (IPV), which is defined as serious physical or sexual violence that occurs outside the context of consensual bondage or sado-masochistic sexual play, which results in concerns about safety.
  • At the first in-person meeting, staff will be empowered to deem the couple ineligible for the intervention if they identify inconsistencies between information provided in the eligibility screener and the in-person meeting (e.g., discrepancies in age or duration of relationship) or any issues that might hinder participation (e.g., attending meeting high or drunk). The couple may also be deemed ineligible if participant responses are sufficiently inconsistent to call into question the validity of their individual responses.

Outcomes

Primary Outcomes

Proportion of Respondents Reporting Any Drug Use

Time Frame: 30 days prior to assessment

The outcome measure is a dichotomous variable indicating whether or not each participant reported any drug use in the in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated the use of any drugs at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention.

Condomless Anal Sex With Casual Partners

Time Frame: 30 days prior to assessment

The outcome measure is a dichotomous variable indicating whether or not each participant indicated the occurrence of any insertive or receptive condomless anal sex (CAS) with a casual partner in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated any CAS with a casual partner at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention.

Drug Abuse Screening Test-10 Total Scores

Time Frame: 30 days prior to assessment

The scale assesses the number of drug use related problems experienced by the participant in the 30 days prior to the assessment. Higher scores indicate a greater number of drug use related problems. Note, assessments were conducted at 1, 3, and 6 months post intervention.

Study Sites (1)

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