Addressing Substance Use Through CVCT

NCT03125915 | Completed Results DMC

• 1 other identifier: R34DA036419
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Sex, Unsafe; Drug Use

Keywords

couples HIV testing; drug intervention; communication skills

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (4)

CHTC as usual

ACTIVE COMPARATOR

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

Behavioral: Couples HIV Testing and Counseling

CHTC + communication skills videos

EXPERIMENTAL

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

Behavioral: Communication skills training video; Behavioral: Couples HIV Testing and Counseling

CHTC + substance use module

EXPERIMENTAL

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.

Behavioral: substance use module; Behavioral: Couples HIV Testing and Counseling

CHTC + video + substance use module

EXPERIMENTAL

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.

Behavioral: Communication skills training video; Behavioral: substance use module; Behavioral: Couples HIV Testing and Counseling

Interventions

Communication skills training video BEHAVIORAL

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.

CHTC + communication skills videos; CHTC + video + substance use module

substance use module BEHAVIORAL

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.

Also known as: drug calendar

CHTC + substance use module; CHTC + video + substance use module

Couples HIV Testing and Counseling BEHAVIORAL

CHTC delivered as per the CDC protocol.

Also known as: (CHTC)

CHTC + communication skills videos; CHTC + substance use module; CHTC + video + substance use module; CHTC as usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: participants must identify as male gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Hunter College

New York, New York, 10018, United States

Location

Related Publications (4)

• 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.

  PMID: 31203148 BACKGROUND

• 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.

  PMID: 29651646 BACKGROUND

• 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.

  PMID: 28745559 BACKGROUND

• 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.

  PMID: 30887190 RESULT

MeSH Terms

Conditions

Unsafe Sex

Interventions

Counseling; chitinase C

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

The design does not permit inferences about effects of components delivered independently of CHTC. The sample was recruited in a major metropolitan area and at relatively lower risk for HIV infection.

Results Point of Contact

• Title: Tyrel Starks, Associate Professor
• Organization: Hunter College, CUNY

tstarks@hunter.cuny.edu

212-206-7919

Study Officials

• Tyrel J Starks, PhD

  Hunter College, CUNY

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 24, 2017
• Study Start: April 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 15, 2021
• Results First Posted: February 26, 2020

Record last verified: 2021-03

Locations

US (1)