Clinical trial NCT03125915: Addressing Substance Use Through CVCT
Official title: Addressing Substance Use Through Couples Voluntary Counseling and Testing (CVCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sex, Unsafe
Drug Use
Keywords: couples HIV testing; drug intervention; communication skills
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-04-24
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Respondents Reporting Any Drug Use
timeFrame: 30 days prior to assessment
measure: Condomless Anal Sex With Casual Partners
timeFrame: 30 days prior to assessment
measure: Drug Abuse Screening Test-10 Total Scores
timeFrame: 30 days prior to assessment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College
state: New York
Study officials:
affiliation: Hunter College, CUNY
name: Tyrel J Starks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.