背景：每年报告的所有结核病（TB）病例中约有7％是复发的，发生在最近或遥远的过去患有结核病的人群中。结核病复发在印度尤其常见，全球结核病负担最大。尽管最近接受结核病治疗的患者再次发展结核病的风险很高，在这一人群中，有效的主动病例发现(ACF)策略的证据很少。我们将进行混合I型有效性实施非劣效性随机试验，以比较有效性，成本效益，以及在已完成结核病治疗的个人及其家庭接触者（HHCs）中采用两种ACF策略的可行性。
方法：我们将招募1076名成年人（≥18岁），他们在浦那的公共结核病单位（TU）完成了结核病治疗，印度,以及他们的HHC(平均每个病人两个，n=2152）。参与者将以6个月的间隔由现有的医护人员（HCWs）进行基于症状的ACF，并将被随机分配到基于家庭的ACF（HACF）或电话ACF（TACF）。有症状的参与者将通过该计划进行微生物学测试。根据国家指南，无症状HHC将被推荐用于结核病预防性治疗（TPT）。主要结果是研究小组诊断为新发或复发性结核病的每100人年的比率，治疗完成后12个月内。次要结果是HHCs的比例<6年，通过研究手臂，在排除结核病后开始接受TPT。研究人员将收集社会人口统计学和临床数据，以确定结核病复发的危险因素，并测量结核病后肺损伤。在双臂中，将进行为期18个月的“扫荡”访问以确定结果。我们将使用RE-AIM框架来描述实施过程，并通过对索引患者的深入访谈来探索可接受性，HHCs和HCWs(n=100)。将通过计算12个月内检测到的每例结核病病例的增量成本来评估成本效益，并根据对发病率的建模估计预测预测残疾调整寿命年。死亡率,和传染性结核病的时间。
结论：这项新的试验将指导印度扩大治疗后ACF的规模，并为设计在其他高负担环境中检测复发和新结核病的策略提供证据基础。
背景：NCT04333485，2020年4月3日注册。CTRI/2020/05/025059[印度临床试验注册]，2020年5月6日注册。
BACKGROUND: Approximately 7% of all reported tuberculosis (TB) cases each year are recurrent, occurring among people who have had TB in the recent or distant past. TB recurrence is particularly common in India, which has the largest TB burden worldwide. Although patients recently treated for TB are at high risk of developing TB again, evidence around effective active
case finding (ACF) strategies in this population is scarce. We will conduct a hybrid type I effectiveness-implementation non-inferiority randomized trial to compare the effectiveness, cost-effectiveness, and feasibility of two ACF strategies among individuals who have completed TB treatment and their household contacts (HHCs).
METHODS: We will enroll 1076 adults (≥ 18 years) who have completed TB treatment at a public TB unit (TU) in Pune, India, along with their HHCs (averaging two per patient, n = 2152). Participants will undergo symptom-based ACF by existing healthcare workers (HCWs) at 6-month intervals and will be randomized to either home-based ACF (HACF) or telephonic ACF (TACF). Symptomatic participants will undergo microbiologic testing through the program. Asymptomatic HHCs will be referred for TB preventive treatment (TPT) per national guidelines. The primary outcome is rate per 100 person-years of people diagnosed with new or recurrent TB by study arm, within 12 months following treatment completion. The secondary outcome is proportion of HHCs < 6 years, by study arm, initiated on TPT after ruling out TB disease. Study staff will collect socio-demographic and clinical data to identify risk factors for TB recurrence and will measure post-TB lung impairment. In both arms, an 18-month \"mop-up\" visit will be conducted to ascertain outcomes. We will use the RE-AIM framework to characterize implementation processes and explore acceptability through in-depth interviews with index patients, HHCs and HCWs (n = 100). Cost-effectiveness will be assessed by calculating the incremental cost per TB
case detected within 12 months and projected for disability-adjusted life years averted based on modeled estimates of morbidity, mortality, and time with infectious TB.
CONCLUSIONS: This novel trial will guide India\'s scale-up of post-treatment ACF and provide an evidence base for designing strategies to detect recurrent and new TB in other high burden settings.
BACKGROUND: NCT04333485 , registered April 3, 2020. CTRI/2020/05/025059 [Clinical Trials Registry of India], registered May 6 2020.
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