Phone-based screening versus home-based screening after tuberculosis in India (TB Aftermath): a multicentre, open-label, randomised, controlled, non-inferiority trial.

IF 22.5 1区医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Lancet Global Health Pub Date : 2026-07-02 DOI:10.1016/j.langlo.2026.103971

Samyra R Cox,Abhay Kadam,Shahanara Valawalkar,Gayatri Lele,Aye Hnin Moe,Vipul Dhamale,Akshay N Gupte,Nishi Suryavanshi,Emily A Kendall,Hojoon Sohn,Christopher J Hoffmann,Arjunlal Kakrani,Ryan Thompson,Nikhil Gupte,Madhu Sudan Barthwal,Jonathan E Golub,Vidya Mave,

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Abstract

BACKGROUND Tuberculosis survivors and their household contacts are at increased risk for tuberculosis even after treatment completion; however, effective strategies for post-tuberculosis screening remain untested. We aimed to assess whether phone-based screening is non-inferior to home-based screening for tuberculosis after treatment completion in India. METHODS In this multicentre, open-label, randomised, controlled, non-inferiority trial, we enrolled tuberculosis survivors (aged >18 years) within 60 days of completing treatment for any form of tuberculosis from six public clinics in Maharashtra, India. Household contacts were enumerated at baseline (all ages). Survivors were randomly assigned (1:1) to receive phone-based or home-based symptom screening at 6 months and 12 months. The trial was powered to identify a difference in the tuberculosis detection rate per 100 person-years among survivors and contacts together (primary outcome), comparing screening groups during the 12 months after survivor treatment completion. We conducted an intention-to-treat analysis with a rate difference non-inferiority margin of 1·70 per 100 person-years based on the upper bound of the 95% CI. We adjusted for household-level clustering of tuberculosis by fitting a multilevel Poisson model. We also conducted a subgroup analysis of detection rates among survivors and contacts separately. This study is registered with ClinicalTrials.gov, NCT04333485 and is completed. FINDINGS We enrolled 1076 tuberculosis survivors (537 in the phone-based screening group and 539 in the home-based screening group) and enumerated 3309 contacts (1638 in the phone-based screening group and 1671 in the home-based screening group) between Jan 21, 2021, and Sept 4, 2023. In the 12-month post-treatment period, tuberculosis was detected in 75 (7%) tuberculosis survivors and 30 (1%) contacts: 41 events in the phone-based screening group (rate 1·19 [95% CI 0·82-1·71]) compared with 64 events in the home-based screening group (1·92 [1·37-2·45]). Non-inferiority was reached (rate difference 0·73 [95% CI 0·05-1·41]). Among tuberculosis survivors, the recurrence detection rate was 4·36 (95% CI 2·87-6·34) in the phone-based screening group compared with 8·00 (5·90-10·60) in the home-based screening group (p=0·01). Among contacts, the tuberculosis detection rate was 0·61 (95% CI 0·32-1·07) in the phone-based screening group compared with 0·70 (0·39-1·20) in the home-based screening group (p=0·70). INTERPRETATION Risk of tuberculosis remains high for households with a tuberculosis survivor. For detecting tuberculosis among survivors and their household contacts together, phone-based screening was non-inferior to home-based screening. For survivors, the recurrence detection rate was higher in the home-based screening group. Countries with a high burden of recurrence should consider home-based screening among tuberculosis survivors. FUNDING US National Institute of Allergy and Infectious Diseases.

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印度结核病后电话筛查与家庭筛查：一项多中心、开放标签、随机、对照、非劣效性试验。

背景：结核病幸存者及其家庭接触者即使在治疗完成后患结核病的风险仍在增加；然而，结核病后筛查的有效策略仍未得到检验。我们的目的是评估在印度完成治疗后，基于电话的结核病筛查是否优于基于家庭的筛查。方法：在这项多中心、开放标签、随机、对照、非效性试验中，我们招募了来自印度马哈拉施特拉邦6家公立诊所的结核病幸存者（年龄在0 - 18岁），他们在完成任何形式的结核病治疗后60天内存活。以基线（所有年龄）点算家庭接触者。幸存者被随机分配（1:1）在6个月和12个月时接受基于电话或基于家庭的症状筛查。该试验旨在确定幸存者和接触者之间每100人年结核病检出率的差异（主要结局），比较幸存者治疗完成后12个月内的筛查组。我们进行了意向治疗分析，基于95% CI的上限，比率差异非劣效性裕度为1.70 / 100人年。我们通过拟合多水平泊松模型调整了结核病的家庭水平聚类。我们还分别对幸存者和接触者的检出率进行了亚组分析。本研究已在ClinicalTrials.gov注册，编号NCT04333485，并已完成。在2021年1月21日至2023年9月4日期间，我们招募了1076名结核病幸存者（537人在电话筛查组，539人在家庭筛查组），并枚举了3309名接触者（1638人在电话筛查组，1671人在家庭筛查组）。在治疗后12个月期间，在75名（7%）结核病幸存者和30名（1%）接触者中检测到结核病：电话筛查组有41例（比率1.19 [95% CI 0.82 -1·71]），而家庭筛查组有64例（比率1.92[1.37 - 2.45]）。达到非劣效性（率差0.73 [95% CI 0.05 - 1.41]）。在结核病幸存者中，电话筛查组的复发率为4.36 (95% CI 2.87 ~ 6.34)，而家庭筛查组的复发率为8.00 (95% CI 5.90 ~ 10.60) （p= 0.01）。接触者中，电话筛查组肺结核检出率为0.61 (95% CI为0.32 ~ 1.07)，家庭筛查组为0.70 (95% CI为0.39 ~ 1.20)（p= 0.70）。对于有结核病幸存者的家庭来说，患结核病的风险仍然很高。对于幸存者及其家庭接触者之间的结核病检测，基于电话的筛查并不亚于基于家庭的筛查。对于幸存者来说，家庭筛查组的复发率更高。复发负担高的国家应考虑对结核病幸存者进行家庭筛查。美国国家过敏和传染病研究所。

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来源期刊

Lancet Global Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-

CiteScore

44.10

自引率

1.20%

发文量

763

审稿时长

10 weeks

期刊介绍： The Lancet Global Health is an online publication that releases monthly open access (subscription-free) issues.Each issue includes original research, commentary, and correspondence.In addition to this, the publication also provides regular blog posts. The main focus of The Lancet Global Health is on disadvantaged populations, which can include both entire economic regions and marginalized groups within prosperous nations.The publication prefers to cover topics related to reproductive, maternal, neonatal, child, and adolescent health; infectious diseases (including neglected tropical diseases); non-communicable diseases; mental health; the global health workforce; health systems; surgery; and health policy.