The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients
The Starting Treatment for Ethanol in Primary care Trials (STEP Trials): Protocol for Three Parallel Multi-Site Stepped Care Effectiveness Studies for Unhealthy Alcohol Use in HIV-Positive Patients
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DOI：
10.1016/j.cct.2016.11.008
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发表时间：
2017-01-01
影响因子：
2.2
通讯作者：
Fiellin, David A.
中科院分区：
文献类型：
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作者：
Edelman, E. Jennifer;Maisto, Stephen A.;Fiellin, David A.
不健康饮酒在 HN 阳性患者中很常见，但在提供 HIV 护理的临床环境中很少提供有效的循证治疗。此外，考虑到患者对初始治疗的反应存在差异，阶梯式护理方法可能是有益的。我们描述了当前初级保健试验中乙醇起始治疗（STEP 试验）的基本原理、目标和研究设计；五个传染病诊所正在进行三项平行随机对照有效性试验。符合以下标准的参与者：1) 有饮酒风险，2) 患有肝病的中度饮酒 (MAID)，或 3) 酒精使用障碍 (AUD) 被随机分配到综合阶梯护理组与常规治疗组。对于那些有饮酒或 MALD 风险的人，综合阶梯护理从一次简短的干预和后续 2 周的电话加强治疗开始。根据预先指定的无反应标准，参与者可能会在第 4 周“加强”接受四次动机增强治疗 (MET)，并在第 12 周再次“加强”接受成瘾医生管理 (APM) 并考虑酒精药物治疗。对于患有 AUD 的患者，综合阶梯护理从 APM 开始。无反应者可能会在第 4 周“加强”接受 MET，并在第 12 周再次“加强”以获得更高水平的护理（例如重症门诊计划）。主要结果是 24 周时评估的饮酒量，次要结果是 VACS 指数，这是一种经过验证的 HIV 发病率和死亡风险衡量指标。 STEP 试验的结果应该为未来的研究和干预措施的实施提供信息，以解决艾滋病毒阳性者中不健康的饮酒问题。 (C) 2016 Elsevier Inc. 保留所有权利。
Unhealthy alcohol use is common among HN-positive patients, yet effective evidence-based treatments are rarely provided in clinical settings providing HIV care. Further, given patient variability in response to initial treatments, stepped care approaches may be beneficial. We describe the rationale, aims and study design for the current Starting Treatment for Ethanol in Primary care Trials (STEP Trials); three parallel randomized controlled effectiveness trials being conducted in five Infectious Disease Clinics. Participants meeting criteria for: 1) at-risk drinking, 2) moderate alcohol use with liver disease (MAID), or 3) alcohol use disorder (AUD) are randomized to integrated stepped care versus treatment as usual. For those with at-risk drinking or MALD, integrated stepped care starts with a one session brief intervention and follow-up 2-week telephone booster. Based on pre-specified nonresponse criteria, participants may be "stepped up" at week 4 to receive four sessions of motivational enhancement therapy (MET) and "stepped up" again at week 12 for addiction physician management (APM) and consideration of alcohol pharmacotherapy. For those with AUD, integrated stepped care begins with APM. Non-responders may be "stepped up" at week 4 to receive MET and again at week 12 for a higher level of care (e.g. intensive outpatient program). The primary outcome is alcohol consumption assessed at 24 weeks, and secondary outcome is the VACS Index, a validated measure of HIV morbidity and mortality risk. Results from the STEP Trials should inform future research and the implementation of interventions to address unhealthy alcohol use among HIV-positive individuals. (C) 2016 Elsevier Inc. All rights reserved.