Addressing Substance Use Through CVCT

Not Applicable

Completed

Conditions: Sex, Unsafe
Drug Use

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

Registration Number: NCT03125915

Lead Sponsor: Hunter College of City University of New York

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 140

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
CHTC + substance use module	substance use module	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.
CHTC + video + substance use module	Communication skills training video	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.
CHTC as usual	Couples HIV Testing and Counseling	Participants receive couples HIV testing and counseling following the CDC approved protocol.
CHTC + communication skills videos	Communication skills training video	The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.
CHTC + communication skills videos	Couples HIV Testing and Counseling	The couple views communication skills training videos together prior to participating in a CHTC session following the CDC approved protocol.
CHTC + video + substance use module	Couples HIV Testing and Counseling	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.
CHTC + substance use module	Couples HIV Testing and Counseling	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.
CHTC + video + substance use module	substance use module	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Respondents Reporting Any Drug Use	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	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	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.