Hybrid trial for Alcohol reduction among people with TB and HIV in India (HATHI)

印度结核病和艾滋病毒感染者减少饮酒的混合试验 (HATHI)

• 批准号: 10435573
• 负责人: GEETANJALI CHANDER
• 金额: $ 58.25万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-05 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10435573
• 关键词: AIDS/HIV problem; Accounting; Acquired Immunodeficiency Syndrome; Address; Adherence; Adoption; Affect; Alcohol abuse; Alcohol consumption; Alcohols; Behavior Therapy; Behavioral; Biological Markers; Caring; Cessation of life; Clinic; Clinical; Cognitive Therapy; Conduct Clinical Trials; Counseling; Country; Disease; Effectiveness; Epidemiologist; Ethanol; Failure; Funding; General Population; Goals; HIV; HIV/TB; Health; Health Care Costs; Health Personnel; Health system; Heavy Drinking; High Prevalence; Hospitals; Hybrids; Incidence; Income; India; Individual; Intervention; Maintenance; Measures; Methods; Outcome; Outcome Measure; Patient Self-Report; Patients; Persons; Policies; Population; Predisposition; Primary Infection; Provider; RNA; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Research; Resources; Risk; Scientist; Sputum; Testing; Time; Treatment Cost; Treatment Failure; Treatment outcome; Tuberculosis; United States National Institutes of Health; Viral; Work; alcohol abuse therapy; alcohol intervention; alcohol misuse; antiretroviral therapy; arm; care providers; care seeking; co-infection; comparative effectiveness; cost; cost effectiveness; disability-adjusted life years; drinking; effective intervention; effectiveness implementation study; effectiveness outcome; effectiveness-implementation RCT; evidence base; implementation determinants; implementation fidelity; implementation framework; implementation measures; implementation outcomes; improved; improved outcome; incremental cost-effectiveness; innovation; intervention cost; low and middle-income countries; medication compliance; mortality; motivational enhancement therapy; multidisciplinary; prevent; recruit; social stigma; therapy adherence; treatment adherence; treatment as usual; tuberculosis treatment

The highest incidence of tuberculosis disease (TB) in the world is in India, accounting for 27% of all new cases globally, with approximately 86,000 among persons with HIV (PWH). Unhealthy alcohol use triples the risk of TB in the general population, increasing susceptibility to primary infection and reactivation, and also leads to poor TB outcomes including decreased treatment adherence, treatment failure, default and death. Among PWH, unhealthy alcohol use is associated with decreased use of and adherence to antiretroviral therapy (ART), lower viral suppression and increased mortality. Our work in India demonstrates not only high prevalence of unhealthy alcohol use among patients with TB, but also that it is one of the major reasons for treatment default, failure, and mortality. With the high prevalence of unhealthy alcohol use and its association with adverse TB and HIV treatment outcomes in low and middle income countries (LMIC), it is imperative to test scalable, culturally relevant, evidence-based alcohol interventions and measure implementation factors to facilitate more rapid integration of effective interventions into TB and HIV/TB care. To this end, we propose HATHI (Hybrid trial for Alcohol reduction among people with TB and HIV in India). This 2-arm hybrid type 1 effectiveness-implementation RCT will examine the effectiveness of CAP (Counseling on Alcohol Problems), a four-session combined Cognitive Behavioral Therapy/Motivational Enhancement Therapy alcohol reduction intervention integrated into HIV/TB and TB care, compared with usual care (provider advice, referral to treatment as needed). Patients (n=450) with TB (n=225) and HIV/TB co-infection (n=225) and unhealthy alcohol use will be recruited from TB and HIV clinics at 2 large, well-established research and care centers in Pune, Maharashtra India. Effectiveness outcomes measured at 3, 6 and 12 months include 1) self-reported alcohol use and phosphatidyl ethanol (PEth), an alcohol biomarker, and 2) TB and HIV clinical outcomes including TB and HIV medication adherence, HIV viral suppression, TB sputum/culture conversion and the composite outcome of TB treatment failure, default or death. Using the RE-AIM implementation framework, we will use mixed methods to assess barriers and facilitators to alcohol treatment integration in TB and HIV/TB clinical settings and the incremental costs of this intervention strategy. This hybrid effectiveness- implementation study addresses the huge burden of unhealthy alcohol use among persons with TB and TB/HIV in India, the country with the highest burden of TB, 3rd highest burden of HIV, and where unhealthy alcohol use is a significant contributor to unfavorable treatment outcomes. Our multidisciplinary team of epidemiologists, clinicians, health economists and behavioral scientists has a successful track record for conducting clinical trials and alcohol interventions in the US and India. Our research will provide much-needed evidence to inform local and global policy, and improve outcomes for persons most affected by HIV, TB, and unhealthy alcohol use.

世界上结核病疾病（TB）的最高发病率在印度，占所有新病例的27％ 在全球范围内，艾滋病毒（PWH）的人中约有86,000。不健康的饮酒三倍 一般人群中的结核病，增加对原发性感染和重新激活的敏感性，也导致 结核病结果不佳，包括降低治疗依从性，治疗失败，默认和死亡。之中 PWH，不健康的饮酒与使用降低和遵守抗逆转录病毒疗法有关 （ART），降低病毒抑制和死亡率增加。我们在印度的工作不仅表现出很高 结核病患者中不健康的酒精使用率，但这也是主要原因之一 治疗默认，失败和死亡率。随着不健康的酒精使用及其关联的高度流行 在低收入国家（LMIC）中，有不良结核病和艾滋病毒治疗结果，必须 测试可扩展的，具有文化相关的，基于证据的酒精干预措施，并测量实施因素 促进将有效干预措施更快地整合到结核病和HIV/TB护理中。为此，我们提出 HATHI（印度结核病和艾滋病毒患者中饮酒的混合试验）。这个2臂混合动力类型1 有效性实施RCT将检查CAP的有效性（对酒精问题的咨询），一个 四参与认知行为疗法/动机增强疗法降低酒精饮酒 与通常的护理相比 根据需要进行治疗）。患者（n = 450），结核病（n = 225）和HIV/TB共感染（n = 225）和不健康 酒精使用将从TB和HIV诊所招募，该诊所在2个大型，公认的研究和护理中心 马哈拉施特拉邦印度浦那。在3、6和12个月测得的有效性结果包括1）自我报告 酒精使用和磷脂酰乙醇（Peth），酒精生物标志物以及2）结核病和HIV临床结果 包括结核病和HIV药物依从性，HIV病毒抑制，TB痰/培养conversion依和 结核病治疗失败，默认或死亡的综合结果。使用RE-AIM实施框架，我们 将使用混合方法来评估结核病和HIV/TB中酒精治疗整合的障碍和促进因子 临床环境和此干预策略的增量成本。这种混合有效性 - 实施研究解决了结核病患者和 印度的结核病/艾滋病毒是结核病负担最高的国家，艾滋病毒的第三大负担，不健康 饮酒是不利治疗结果的重要贡献者。我们的多学科团队 流行病学家，临床医生，卫生经济学家和行为科学家都成功地记录了 在美国和印度进行临床试验和酒精干预措施。我们的研究将提供急需的 有证据以告知地方和全球政策，并改善受艾滋病毒，结核病和最大影响的人的结果 不健康的酒精使用。