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Addressing Substance Use Through CVCT

Primary Purpose

Sex, Unsafe, Drug Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication skills training video
substance use module
Couples HIV Testing and Counseling
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sex, Unsafe focused on measuring couples HIV testing; drug intervention; communication skills

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Both members of the couple:

  1. are born male and current male gender identity;
  2. identify as gay, bisexual or same-sex attracted;
  3. read English at 8th grade level or better;
  4. have access to the Internet;
  5. agree to audio and video recording of intervention sessions;

At least one member of the couple:

  1. reports the use of any drug listed on the DAST-10 in the previous 30 days.
  2. s identified as HIV negative during screening and baseline assessments.

    The couple

  3. has been together for at least 3 months;
  4. has engaged in oral or anal sex with one another in the past 3 months;

Exclusion Criteria:

  1. 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.
  2. 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.

Sites / Locations

  • Hunter College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

CHTC as usual

CHTC + communication skills videos

CHTC + substance use module

CHTC + video + substance use module

Arm Description

Participants receive couples HIV testing and counseling following the CDC approved protocol.

The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.

The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results.

The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity.

Outcomes

Primary Outcome Measures

Proportion of Respondents Reporting Any Drug Use
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
April 20, 2017
Last Updated
March 23, 2021
Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03125915
Brief Title
Addressing Substance Use Through CVCT
Official Title
Addressing Substance Use Through Couples Voluntary Counseling and Testing (CVCT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: CHTC as usual CHTC + communication skills training videos CHTC + substance use module 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sex, Unsafe, Drug Use
Keywords
couples HIV testing; drug intervention; communication skills

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The study tests two independent variables in a fully-crossed factorial design. Half of the couples complete a substance use module during their CHTC session (half do not); half view communication skills training videos (half do not).
Masking
Care Provider
Masking Description
Assignment to video condition is masked with respect to the care provider. The person conducting the CHTC session is unaware of whether couples have viewed the communication skills training video prior to the session.
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHTC as usual
Arm Type
Active Comparator
Arm Description
Participants receive couples HIV testing and counseling following the CDC approved protocol.
Arm Title
CHTC + communication skills videos
Arm Type
Experimental
Arm Description
The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.
Arm Title
CHTC + substance use module
Arm Type
Experimental
Arm Description
The couple completes a CHTC session which includes the substance use calendar and structured debriefing activity. This is administered following Step 5 in the standard CDC protocol, just prior to delivery of HIV test results.
Arm Title
CHTC + video + substance use module
Arm Type
Experimental
Arm Description
The couple views communication skills training videos together prior to participating in a CHTC session which includes administration of the substance use calendar and structured debriefing activity.
Intervention Type
Behavioral
Intervention Name(s)
Communication skills training video
Intervention Description
This 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.
Intervention Type
Behavioral
Intervention Name(s)
substance use module
Other Intervention Name(s)
drug calendar
Intervention Description
This 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.
Intervention Type
Behavioral
Intervention Name(s)
Couples HIV Testing and Counseling
Other Intervention Name(s)
(CHTC)
Intervention Description
CHTC delivered as per the CDC protocol.
Primary Outcome Measure Information:
Title
Proportion of Respondents Reporting Any Drug Use
Description
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.
Time Frame
30 days prior to assessment
Title
Condomless Anal Sex With Casual Partners
Description
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.
Time Frame
30 days prior to assessment
Title
Drug Abuse Screening Test-10 Total Scores
Description
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.
Time Frame
30 days prior to assessment

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
participants must identify as male gender
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. The couple has been together for at least 3 months; has engaged in oral or anal sex with one another in the past 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyrel J Starks, PhD
Organizational Affiliation
Hunter College, CUNY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter College
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31203148
Citation
Starks TJ, Robles G, Bosco SC, Doyle KM, Dellucci TV. Relationship functioning and substance use in same-sex male couples. Drug Alcohol Depend. 2019 Aug 1;201:101-108. doi: 10.1016/j.drugalcdep.2019.04.009. Epub 2019 May 23.
Results Reference
background
PubMed Identifier
29651646
Citation
Starks TJ, Doyle KM, Shalhav O, John SA, Parsons JT. An Examination of Gay Couples' Motivations to Use (or Forego) Pre-exposure Prophylaxis Expressed During Couples HIV Testing and Counseling (CHTC) Sessions. Prev Sci. 2019 Jan;20(1):157-167. doi: 10.1007/s11121-018-0892-7.
Results Reference
background
PubMed Identifier
28745559
Citation
Starks TJ, Pawson M, Stephenson R, Sullivan P, Parsons JT. Dyadic Qualitative Analysis of Condom Use Scripts Among Emerging Adult Gay Male Couples. J Sex Marital Ther. 2018 Apr 3;44(3):269-280. doi: 10.1080/0092623X.2017.1359713. Epub 2017 Aug 25.
Results Reference
background
PubMed Identifier
30887190
Citation
Starks TJ, Dellucci TV, Gupta S, Robles G, Stephenson R, S Sullivan P, Parsons JT. A Pilot Randomized Trial of Intervention Components Addressing Drug Use in Couples HIV Testing and Counseling (CHTC) with Male Couples. AIDS Behav. 2019 Sep;23(9):2407-2420. doi: 10.1007/s10461-019-02455-2.
Results Reference
result

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Addressing Substance Use Through CVCT

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