FEASIBILITY AND PRELIMINARY EFFECTIVENESS OF A TRANSDIAGNOSTIC COGNITIVE BEHAVIORAL THERAPY TREATMENT APPROACH FOR ALCOHOL MISUSE INTEGRATED WITHIN HIV CARE IN ZAMBIA

赞比亚将酒精滥用跨诊断认知行为疗法纳入艾滋病毒护理的可行性和初步有效性

• 批准号: 10121170
• 负责人: Jeremy Calvin Kane
• 金额: $ 12.23万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-06 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10121170
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Adult; Africa; Africa South of the Sahara; Alcohol abuse; Alcohol consumption; Alcohol or Other Drugs use; Alcohols; Behavior Therapy; Biological Markers; Caring; Clinic; Clinical; Clinical effectiveness; Cognitive Therapy; Country; Data; Databases; Development; Effectiveness; Elements; Enrollment; Environment; Epidemic; Epidemiology; Evidence based intervention; Evidence based treatment; Female; Focus Groups; Funding; Glucuronides; Goals; HIV; Health; Health care facility; Health system; Human Resources; Hybrids; Income; Individual; Inhalant dose form; Integrative Therapy; International; Intervention; Interview; Manuals; Measures; Mental Health; Methods; Modeling; National Institute of Allergy and Infectious Disease; Outcome; Participant; Patient Self-Report; Patients; Persons; Prevalence; Procedures; Program Development; Prospective cohort; Randomized; Reporting; Research; Resources; Severities; Structure; Symptoms; Testing; Therapeutic Intervention; Time; Training; United States National Institutes of Health; Urine; Viral; Viral Load result; Zambia; alcohol abstinence; alcohol abuse therapy; alcohol comorbidity; alcohol intervention; alcohol misuse; alcohol use disorder; antiretroviral therapy; base; behavioral health; brief alcohol intervention; brief intervention; cohort; comorbidity; cost effective; cost effectiveness; effective therapy; effectiveness implementation study; evidence base; follow-up; hazardous drinking; implementation strategy; improved; informant; innovation; male; mortality; novel; prospective; reduced alcohol use; response; standard of care; substance misuse; therapy adherence; therapy development; transmission process; treatment program; uptake; virtual

Alcohol use is increasing in sub-Saharan Africa (SSA) where it commonly intersects with the HIV/AIDS epidemic. Hazardous alcohol use increases HIV transmission, impedes uptake and retention on antiretroviral therapy (ART), and ultimately reduces HIV viral suppression (VS). Approximately 20-50% of persons living with HIV (PLWH) on ART drink hazardously; however, most clinics in SSA offer only brief interventions (BIs) for alcohol reduction that are ineffective for many patients. BIs have limited ability to address more severe alcohol use disorders (AUDs) or comorbid mental health or substance use issues (hereafter called `comorbidities') that are common among PLWH. In preliminary studies, we found that 40% of male and 20% of female PLWH on ART in Zambia had hazardous alcohol use, that ~60% failed to respond to current BIs, and that >50% had comorbidities. We previously developed and demonstrated the effectiveness of a novel cognitive-behavioral therapy intervention, Common Elements Treatment Approach (CETA), which trains lay health workers to address both AUDs and comorbidities. Our central hypothesis is that a stepped care approach to alcohol use, where interventions ranging in time and resource intensity are provided according to symptom severity, can be utilized by HIV treatment programs in SSA to effectively and efficiently address hazardous alcohol use and improve HIV outcomes. In this application, we propose a Stage 1 hybrid effectiveness-implementation study to adapt and pilot test CETA at two Zambian HIV clinics for PLWH who report hazardous alcohol use and are less likely to respond to BIs (i.e., those with moderate-to-severe alcohol use disorders (AUDs) and/or comorbidities). This project leverages (a) our development of CETA, (b) a prospective cohort of HIV-infected individuals that was created by the NIAID-funded International Epidemiological Databases to Evaluate AIDS, and (c) >10 years of HIV and mental health research in Zambia. Aim 1 will adapt the current CETA manual for HIV-infected individuals and HIV clinics with input from PLWH, health workers, and key informants in the health system. In Aim 2, PLWH who screen positive for hazardous alcohol use will be enrolled and assessed for AUD and comorbidities. Those with moderate-to-severe AUD and/or comorbidities (n=160) will be randomized 1:1 to receive BI alone or BI+CETA. Participants with subthreshold/mild AUD and without comorbidities will also receive the BI. Changes in alcohol use, comorbidities, and HIV outcomes (ART retention and HIV viral suppression) will be measured over 6 months of follow-up and the impact of the interventions will be evaluated. Urine Ethyl glucuronide testing will be used to augment self-reported alcohol measures. Aim 3 will investigate feasibility, acceptability, and other implementation factors related to delivery of BI and CETA. This study will: (1) result in an HIV-adapted CETA manual, (2) generate preliminary effectiveness and implementation data on CETA and BI in PLWH drinkers with comorbidities, and (3) inform an R01 application to further test a stepped care approach to address hazardous drinking in HIV care settings.

在撒哈拉以南非洲(SSA)，酒精的使用正在增加，在那里它通常与艾滋病毒/艾滋病交叉 流行病。危险饮酒会增加艾滋病毒的传播，阻碍抗逆转录病毒的吸收和滞留 治疗(ART)，并最终减少艾滋病毒病毒抑制(VS)。大约20%-50%的人与 艾滋病病毒(PLWH)对ART饮酒是危险的；然而，SSA的大多数诊所只提供短暂的干预(BIS) 对许多患者无效的酒精减量。国际清算银行解决更严重酒精问题的能力有限 使用障碍(AUD)或共病的精神健康或物质使用问题(以下称为“共病”) 在PLWH中很常见。在初步研究中，我们发现40%的男性和20%的女性在 赞比亚的ART曾使用过危险的酒精，约60%的人没有对当前的国际清算银行做出反应，而50%的人有 合并症。我们以前开发并演示了一种新的认知行为的有效性 治疗干预，通用元素治疗方法(CETA)，培训业馀卫生工作者 同时解决急性尿路感染和合并症。我们的中心假设是，对酒精使用采取循序渐进的护理方法， 在根据症状严重程度提供时间和资源强度不等的干预措施的情况下，可以 被SSA的艾滋病毒治疗计划用来有效和高效地解决危险的酒精使用和 改善艾滋病毒的结果。在这项应用中，我们提出了第一阶段混合有效性-实施研究，以 在赞比亚两家艾滋病毒诊所为报告使用危险酒精且较少的PLWH适应和试点CETA测试 可能对BIS做出反应(即，有中到重度酒精使用障碍(AUD)和/或 合并症)。该项目利用(A)我们制定的CETA，(B)预期的艾滋病毒感染者队列 由NIAID资助的国际流行病学数据库创建的评估艾滋病的个人， 以及(C)在赞比亚从事了10年的艾滋病毒和精神卫生研究。AIM 1将对当前的CETA手册进行调整，以适应 艾滋病毒感染者和艾滋病毒诊所，由公共卫生署、卫生工作者和卫生领域的主要信息提供者提供意见 系统。在目标2中，危险酒精使用筛查呈阳性的PLWH将被登记并评估AUD 以及合并症。那些患有中到重度AUD和/或合并疾病(n=160)的患者将被随机分为1：1到 单独接受BI或BI+CETA。阈值以下/轻度AUD且无合并症的参与者也将 接收BI。酒精使用、合并症和艾滋病毒结果的变化(抗逆转录病毒药物残留和艾滋病毒病毒 将在6个月的后续行动中衡量)，并将评估干预措施的影响。 尿乙基葡萄糖醛酸脂测试将用于增强自我报告的酒精含量。AIM 3将调查 与交付BI和CETA相关的可行性、可接受性和其他实施因素。这项研究将： (1)编制适应艾滋病毒的CETA手册，(2)就以下方面产生初步有效性和执行数据 CETA和BI在患有共病的PLWH饮酒者中，以及(3)通知R01申请进一步测试STEP 处理艾滋病毒护理环境中危险饮酒问题的护理方法。