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

世界上结核病发病率最高的是印度，占所有新增病例的27%。 在全球范围内，艾滋病毒携带者中约有86,000人。不健康的饮酒会使患病风险增加两倍 结核病在普通人群中，增加了对初次感染和重新激活的易感性，并还导致 结核病结果不佳，包括治疗依从性降低、治疗失败、违约和死亡。其中 PWH，不健康的酒精使用与减少使用和坚持抗逆转录病毒治疗有关 (ART)，较低的病毒抑制和更高的死亡率。我们在印度的工作不仅证明了 结核病患者中普遍存在不健康的酒精使用，但这也是导致 治疗失误、失败和死亡率。与不健康饮酒的高流行率及其关联 随着低收入和中等收入国家结核病和艾滋病毒治疗结果的恶化，当务之急是 测试可扩展的、与文化相关的循证酒精干预措施，并衡量实施因素以 促进将有效干预措施更快地纳入结核病和艾滋病毒/结核病护理。为此，我们建议 Hathi(印度结核病和艾滋病毒携带者减少酒精混合试验)。这款双臂混合动力车为1型 有效性--执行RCT将审查CAP(酒精问题咨询)的有效性，a 认知行为疗法/动机增强疗法相结合的四疗程戒酒 与常规护理相比，将干预措施纳入艾滋病毒/结核病和结核病护理(提供者咨询、转介至 根据需要进行治疗)。患有结核病(n=225)和艾滋病毒/结核病混合感染(n=225)和不健康的患者(n=450) 酒精使用将从两个大型、成熟的研究和护理中心的结核病和艾滋病毒诊所招募 印度马哈拉施特拉邦浦那。在3个月、6个月和12个月时测量的有效性结果包括1)自我报告 酒精使用和酒精生物标记物磷脂酰乙醇(Peth)，以及2)结核病和艾滋病毒的临床结果 包括结核病和艾滋病毒药物依从性、艾滋病毒抑制、结核病痰/培养转换以及 结核病治疗失败、违约或死亡的综合结果。使用RE-AIM实施框架，我们 将使用混合方法评估结核病和艾滋病毒/结核病酒精治疗一体化的障碍和促进者 临床环境和这一干预策略的增量成本。这种混合效果-- 实施研究解决了结核病患者中不健康饮酒的巨大负担 印度的结核病/艾滋病毒，是结核病负担最高的国家，艾滋病毒负担第三高，而且不健康 酒精使用是导致不良治疗结果的一个重要因素。我们的多学科团队 流行病学家、临床医生、健康经济学家和行为科学家在 在美国和印度进行临床试验和酒精干预。我们的研究将提供急需的 为当地和全球政策提供信息，并改善受艾滋病毒、结核病和艾滋病影响最大的人的结果 不健康的饮酒行为。

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.