Addressing Substance Use Through Couples Voluntary Counseling and Testing (CVCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Proportion of Respondents Reporting Any Drug Use
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
- •has been together for at least 3 months;
- •has engaged in oral or anal sex with one another in the past 3 months;
排除标准
- •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.
结局指标
主要结局
Proportion of Respondents Reporting Any Drug Use
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Tyrel Starks
Associate Professor
Hunter College of City University of New York