Alcohol Research Consortium in HIV-Intervention Research Arm
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4,985
- 试验地点
- 2
- 主要终点
- Audit-C Score on a Scale
研究概览
简要总结
Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms.
Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes.
Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions
详细描述
Aim 1: Examine effects of algorithm-guided alcohol treatment on alcohol consumption and alcohol use Disorders (AUD) symptoms. Hypothesis 1A: Patients who are treated using algorithm-guided alcohol treatment will decrease drinking quantity and or frequency compared to pre-algorithm levels. Hypothesis 1B. Patients who are treated using algorithm-guided treatment will decrease current AUD symptoms compared to pre-algorithm symptoms levels.
Aim 2: Examine effects of algorithm-guided alcohol treatment on retention in HIV care and HIV-related outcomes. Hypothesis 2A. Patients treated using algorithm-guided treatment will increase adherence to clinic visits and HIV medications compared to pre-algorithm levels. Hypothesis 2B. Patients who receive algorithm-guided treatment will have improved HIV biomarkers (e.g., CD4 and VL). Hypothesis 3B. There will be a positive relationship between VL and alcohol consumption measured by self-report and PEth level.
Aim 3: Examine effects of algorithm-guided alcohol treatment on comorbid conditions (e.g., depression, anxiety, HCV, other drug use disorders). Hypothesis 3A: Persons living with HIV (PLWH) with co-morbid depression and anxiety receiving algorithm-guided treatment will have better alcohol, mental health and HIV treatment outcomes compared to similar individuals in SC. Hypothesis 3B: PLWH with comorbid HCV receiving algorithm-guided treatment will have improved FIB4 results and reduced likelihood of HCV recurrence compared to persons in SC. Hypothesis 3C: Other drug use will decrease among those receiving algorithm-guided treatment vs SC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years or older;
- •Receiving HIV care at the UAB, UW or UCSD clinics and not anticipating changing clinics over the next 12 months;
- •AUDIT-C score > 3 women or > 4 men at time of PRO.
排除标准
- •Non-English speaking;
- •Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent.
研究组 & 干预措施
No dx of alcohol use disorder, panic or depression
Computerized Brief Intervention (CBI)- a video about alcohol abuse
干预措施: Computerized Brief Intervention (CBI) (Behavioral)
Risky drinking, no dx of AUD, has panic or depression
Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy
干预措施: Computerized Brief Intervention (CBI) (Behavioral)
Risky drinking, no dx of AUD, has panic or depression
Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy
干预措施: CBT4CBT (Behavioral)
Dx of AUD with or without panic or depression
Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol.
干预措施: Computerized Brief Intervention (CBI) (Behavioral)
Dx of AUD with or without panic or depression
Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol.
干预措施: CBT4CBT (Behavioral)
Dx of AUD with or without panic or depression
Computerized Brief Intervention (CBI)- a video about alcohol abuse, plus 4 sessions of counseling called Motivational Enhancement Therapy plus a recommendation for Alcohol Pharmacotherapy (APT). The drugs recommended in the APT are all standard of care drugs for alcohol treatment and are not under study in this protocol.
干预措施: Recommendation and Counseling for Alcohol Pharmacotherapy (Drug)
结局指标
主要结局
Audit-C Score on a Scale
时间窗: 18 month window
Difference in Audit-C score, pre and post intervention. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
次要结局
- PEth Levels(Between baseline and 6 month follow-up)
研究者
Karen Cropsey
Principal Investigator
University of Alabama at Birmingham