Addressing Substance Use Through CVCT

Study Overview
=================
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.

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

Conditions
-----------------
Sex, Unsafe, Drug Use

Intervention / Treatment
-----------------
* Behavioral: Communication skills training video
* Behavioral: substance use module
* Behavioral: Couples HIV Testing and Counseling


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CHTC as usual<br>Participants receive couples HIV testing and counseling following the CDC approved protocol. | Behavioral: Couples HIV Testing and Counseling<br>* CHTC delivered as per the CDC protocol.<br>* Other names: (CHTC);|
| Experimental: CHTC + communication skills videos<br>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<br>* 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.<br>Behavioral: Couples HIV Testing and Counseling<br>* CHTC delivered as per the CDC protocol.<br>* Other names: (CHTC);|
| Experimental: CHTC + substance use module<br>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<br>* 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.<br>* Other names: drug calendar;Behavioral: Couples HIV Testing and Counseling<br>* CHTC delivered as per the CDC protocol.<br>* Other names: (CHTC);|
| Experimental: CHTC + video + substance use module<br>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<br>* 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.<br>Behavioral: substance use module<br>* 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.<br>* Other names: drug calendar;Behavioral: Couples HIV Testing and Counseling<br>* CHTC delivered as per the CDC protocol.<br>* Other names: (CHTC);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
couples HIV testing; drug intervention; communication skills