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，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。 疫情危险的酒精使用增加了艾滋病毒的传播，阻碍了抗逆转录病毒药物的吸收和保留 抗逆转录病毒疗法（ART），并最终减少HIV病毒抑制（VS）。大约20%至50%的患有 接受抗逆转录病毒治疗的艾滋病毒感染者（PLWH）喝饮料是危险的;然而，撒哈拉以南非洲的大多数诊所只提供简短的干预措施（BI）， 酒精减少对许多患者无效。BI解决更严重酒精问题的能力有限 使用障碍（AUD）或共病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PLWH， 赞比亚的抗逆转录病毒疗法存在危险的酒精使用，约60%的人对当前的生物指示剂没有反应， 合并症。我们以前开发并证明了一种新的认知行为的有效性， 治疗干预，共同要素治疗方法（CETA），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，酒精使用的阶梯式护理方法， 根据症状严重程度提供时间和资源强度不等的干预措施， 利用艾滋病毒治疗方案在SSA有效和高效地解决危险的酒精使用， 改善艾滋病毒成果。在这个应用中，我们提出了一个阶段1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危险酒精使用和较少接触艾滋病毒的艾滋病毒携带者调整和试点测试CETA。 可能对BI有反应（即，中度至重度酒精使用障碍（AUD）患者和/或 合并症）。该项目利用（a）我们的CETA开发，（B）一个前瞻性的HIV感染者队列， 由NIAID资助的评估艾滋病的国际流行病学数据库创建的个人， （c）在赞比亚进行了10年以上的艾滋病毒和心理健康研究。目标1将修改现行CETA手册， 艾滋病毒感染者和艾滋病毒诊所，以及艾滋病毒携带者、卫生工作者和卫生部门的关键信息提供者的投入 系统在目标2中，将招募危险酒精使用筛查阳性的PLWH并评估AUD 和合并症。中度至重度AUD和/或合并症患者（n=160）将以1：1的比例随机分配至 单独接受BI或BI+CETA。患有亚阈值/轻度AUD且无合并症的受试者还将 接收BI。饮酒、合并症和HIV结局的变化（ART保留和HIV病毒感染） 将在6个月的随访期间对干预措施的效果进行衡量，并对干预措施的影响进行评价。 尿液乙基葡萄糖醛酸苷检测将用于增加自我报告的酒精测量。Aim 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)产生一份适应艾滋病毒的CETA手册，（2）产生初步的有效性和执行数据， CETA和BI在患有合并症的PLWH饮酒者中的应用，以及（3）通知R 01申请，以进一步测试阶梯式 在艾滋病毒护理环境中，采取一种护理方法来解决危险饮酒问题。