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.

撒哈拉以南非洲 (SSA) 的饮酒量正在增加，那里的饮酒通常与艾滋病毒/艾滋病有关 流行性。有害饮酒会增加艾滋病毒传播，阻碍抗逆转录病毒药物的吸收和保留 治疗（ART），并最终减少 HIV 病毒抑制（VS）。大约 20-50% 的人生活在 艾滋病毒感染者（PLWH）饮用抗逆转录病毒疗法（ART）是危险的；然而，SSA 的大多数诊所只提供简短的干预 (BI) 减少饮酒对许多患者来说是无效的。 BI 解决更严重酒精问题的能力有限 使用障碍 (AUD) 或合并心理健康或物质使用问题（以下称为“合并症”） 在 PLWH 中很常见。在初步研究中，我们发现 40% 的男性和 20% 的女性感染者 赞比亚的 ART 存在危险的酒精使用，约 60% 对当前的 BI 没有反应，并且超过 50% 有 合并症。我们之前开发并证明了一种新颖的认知行为的有效性 治疗干预措施，即通用要素治疗方法 (CETA)，该方法培训非专业卫生工作者 解决 AUD 和合并症。我们的中心假设是对饮酒采取阶梯式护理方法， 根据症状严重程度提供不同时间和资源强度的干预措施 SSA 的艾滋病毒治疗计划利用该方案有效地解决有害酒精使用问题 改善艾滋病毒结果。在此应用中，我们提出了第一阶段混合有效性实施研究 在赞比亚的两个艾滋病毒诊所为报告有害酒精使用且较少感染的艾滋病毒感染者进行调整和试点测试 CETA 可能对 BI 有反应（即患有中度至重度酒精使用障碍 (AUD) 和/或 合并症）。该项目利用了 (a) 我们开发的 CETA，(b) 艾滋病毒感染者的前瞻性队列 由 NIAID 资助的国际流行病学数据库创建的用于评估艾滋病的个体， (c) 赞比亚的艾滋病毒和心理健康研究已超过 10 年。目标 1 将调整当前的 CETA 手册 HIV 感染者和 HIV 诊所，包括 PLWH、卫生工作者和卫生领域关键信息提供者的意见 系统。在目标 2 中，有害酒精使用筛查呈阳性的感染者将被纳入并接受澳元评估 和合并症。患有中度至重度 AUD 和/或合并症的患者 (n=160) 将按 1:1 的比例随机分配到 单独接受 BI 或 BI+CETA。患有亚阈值/轻度 AUD 并且没有合并症的参与者也将 接收 BI。饮酒、合并症和 HIV 结果的变化（ART 保留和 HIV 病毒感染） 将在 6 个月的随访期间进行测量，并评估干预措施的影响。 尿液乙基葡萄糖醛酸测试将用于增强自我报告的酒精测量。目标 3 将进行调查 可行性、可接受性以及与 BI 和 CETA 交付相关的其他实施因素。这项研究将： (1) 制定适合 HIV 的 CETA 手册，(2) 生成初步有效性和实施数据 患有合并症的 PLWH 饮酒者的 CETA 和 BI，以及 (3) 通知 R01 申请以进一步测试阶梯式 解决艾滋病毒护理机构中有害饮酒问题的护理方法。