Addressing Substance Use Through CVCT

Drug Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125915
• Other study ID #: R34DA036419
• Secondary ID: R34DA036419
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: February 1, 2018

Study information

• Verified date: March 2021
• Source: Hunter College of City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Use
• Sex, Unsafe

Intervention

Behavioral:
• Communication skills training video
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.
• substance use module
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.
• Couples HIV Testing and Counseling
CHTC delivered as per the CDC protocol.

Locations

Country	Name	City	State
United States	Hunter College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hunter College of City University of New York	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days prior to assessment
Primary	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.	30 days prior to assessment
Primary	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.	30 days prior to assessment