Novel Extensions of Alcohol Contingency Management in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption.
研究概览
简要总结
In this project, the investigators will implement innovations to extend use of Contingency Management (CM) to facilitate alcohol use reduction among people living with HIV (PLWH). The investigators' approach to extending CM will use mobile health (mHealth) tools including a smartphone breathalyzer device with accompanying app and a wrist worn alcohol biosensor. Participants will be engaged in mobile facilitated CM for 30-60 days with follow-up out to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Frequent alcohol use in the past 30 days based on responses on the Timeline Followback (TLFB; Sobell and Sobell, 2003)
- •HIV positive
- •Fluency in English
- •Willingness to attempt alcohol abstinence for at least 30 days and then to attempt alcohol use on fewer days than at baseline after that
- •Willingness to use smartphone applications and biosensor devices (i.e., breathalyzer device and wrist sensor) for alcohol use reduction purposes in the study. If participants do not have a compatible smartphone to use, they will be loaned one by the study
排除标准
- •Psychiatric conditions that would interfere with participation in the study
- •Current alcohol withdrawal as indicated by a score of 8 or higher on the Clinical Institute Withdrawal Scale (CIWA; Sullivan et al., 1989) or lifetime history of medically assisted detoxification
- •Two positive breath alcohol concentration (BrAC) readings (i.e., > 0.00%) at an in-person screening appointment. After participants blow their first positive BrAC, they will be allowed to reschedule and participate at another time, however if they blow a second positive BrAC, they will be excluded from this study and offered referrals for alcohol treatment.
- •Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors
- •Psychosis or other severe psychiatric disability
- •Pregnancy, nursing or lack of reliable birth control use for women who have not yet reached menopause
结局指标
主要结局
Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption.
时间窗: 30 Days to 60 Days
Participants will engage in a Contingency Management program aimed at reducing alcohol consumption. A novel CM delivery system will be used intended to gamify the process.
Predict percent days abstinent via smartphone breathalyzer readings based on risk factors.
时间窗: Baseline to 30 Days
All participants will attempt to reduce alcohol consumption. Only those who are able to will continue to the second phase of the intervention. We will seek to identify which factors are predictive of abstinence.
Drinking reduction through Contingency Management will predict non-drinking outcomes
时间窗: Baseline to 90 days
Participants who are able to successfully reduce their alcohol consumption may see other health benefits including reduced HIV viral load.
Percent days abstinent via smartphone breathalyzer readings
时间窗: Baseline to 30 Days
Within-subject comparison between percent abstinent days based on smartphone breathalyzer readings during the 30-Day Phase 1 Contingency Management induction compared to the 30-day baseline period based on self-report on the timeline followback
次要结局
- Percent days abstinent via wrist biosensor readings(Baseline to 60 Days)