Hunter College
New York, 10018, United States
NCT Number: NCT03125915
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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Notify Me18 year–60 year
Male
Interventional
Not applicable
New York, 10018, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Both members of the couple:
At least one member of the couple:
The couple
Exclusion criteria
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.
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.
Other names: drug calendar
CHTC delivered as per the CDC protocol.
Other names: (CHTC)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Hunter College of City University of New York
Other
Addressing Substance Use Through Couples Voluntary Counseling and Testing (CVCT)
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