Addressing Substance Use Through CVCT

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2018-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sex, Unsafe Drug Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

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.

Study Groups

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CHTC as usual

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

Group Type ACTIVE_COMPARATOR

Couples HIV Testing and Counseling

Intervention Type BEHAVIORAL

CHTC delivered as per the CDC protocol.

CHTC + communication skills videos

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

Group Type EXPERIMENTAL

Communication skills training video

Intervention Type 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.

Couples HIV Testing and Counseling

Intervention Type BEHAVIORAL

CHTC delivered as per the CDC protocol.

CHTC + 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.

Group Type EXPERIMENTAL

substance use module

Intervention Type 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.

Couples HIV Testing and Counseling

Intervention Type BEHAVIORAL

CHTC delivered as per the CDC protocol.

CHTC + video + 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.

Group Type EXPERIMENTAL

Communication skills training video

Intervention Type 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.

substance use module

Intervention Type 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.

Couples HIV Testing and Counseling

Intervention Type BEHAVIORAL

CHTC delivered as per the CDC protocol.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Couples HIV Testing and Counseling

CHTC delivered as per the CDC protocol.

Intervention Type BEHAVIORAL

Other Intervention Names

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drug calendar (CHTC)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes