Impact of distribution of facemasks on community incidence and outcomes of COVID-19: A cluster randomised trial in India

IF 11.9 1区医学 Q1 INFECTIOUS DISEASES

Journal of Infection Pub Date : 2025-08-01 DOI:10.1016/j.jinf.2025.106557

Poppy A.C. Mallinson , Teena Dasi , Santosh Kumar Banjara , Judith Lieber , Santhi Bhogadi , Srivalli Addanki , Prasad Undrajavarapu , Subhash Masapeta , Hemant Mahajan , Bharati Kulkarni , Sanjay Kinra

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引用次数: 0

Abstract

Background

Randomised evidence on the effectiveness of delivering facemasks for reducing the health impact of COVID-19 remains limited.

Methods

We conducted a cluster randomised trial in Telangana, India, in August–November 2020 to investigate whether distribution and promotion of facemasks in villages reduces the incidence and adverse outcomes of COVID-19. We randomised 20 villages from the ongoing APCAPS surveillance study (1:1 ratio) to village-wide distribution of 3-layer cloth facemasks along with promotional messaging, or no intervention. Outcomes were incidence of notified COVID-19 (primary), hospitalised COVID-19 and all-cause mortality (secondary), collected through household surveillance by village health workers. Mask wearing was assessed through standardised observations in village centres. Data were analysed by multilevel Poisson regression.

Findings

Use of the study facemasks and any face coverings in public spaces was higher in intervention villages (19% and 59%, respectively) than control villages (0% and 38%). In the 10 intervention (N=16,741 adults) and 10 control villages (N=15,278 adults), respectively, the crude incidence per thousand person months (number of events) of notified COVID-19 was 2.15 (n=144) and 2.45 (n=150), of hospitalised COVID-19 was 0.07 (n=5) and 0.21 (n=13), and of all-cause mortality was 0.91 (n=61) and 1.10 (n=67). In models accounting for age, sex and pre-intervention COVID-19 rate, rate ratios in intervention versus control villages were 0.96 (95% confidence interval 0.57–1.63) for COVID-19 cases, 0.36 (0.12–1.05) for COVID-19 hospitalisations, and 0.84 (0.55–1.29) for all-cause mortality. No adverse effects were reported.

Interpretation

We are unable to draw firm conclusions about the effect of village-wide distribution and promotion of facemasks on COVID-19 incidence from these data due to a low number of events leading to imprecise effect estimates. Nonetheless, our findings are consistent with the modest protective effect on incident cases seen in previous randomised trials, extending these to adverse outcomes for the first time.

Registration

The trial was pre-registered on the Clinical Trials Registry of India on 25/07/2020 (CTRI/2020/07/026796).

查看原文本刊更多论文

口罩分布对COVID-19社区发病率和结局的影响：印度的一项聚类随机试验

背景：关于发放口罩以减少COVID-19对健康影响的有效性的随机证据仍然有限。方法：我们于2020年8月至11月在印度特伦甘纳邦开展了一项聚类随机试验，调查在村庄分发和推广口罩是否能降低COVID-19的发病率和不良后果。我们从正在进行的APCAPS监测研究中随机抽取20个村庄（比例为1:1），在全村范围内分发3层布口罩，并提供宣传信息，或不进行干预。结果为村卫生工作者通过入户监测收集的通报COVID-19发病率（主要）、住院COVID-19发病率和全因死亡率（次要）。通过村中心的标准化观察评估了口罩佩戴情况。数据采用多水平泊松回归分析。调查结果：干预村在公共场所使用研究口罩和任何面罩的比例（分别为19%和59%）高于对照村（0%和38%）。在10个干预村（N= 16741名成人）和10个对照村（N= 15278名成人）中，通报的COVID-19粗发病率（事件数）分别为2.15 （N= 144）和2.45 (N= 150)，住院的COVID-19粗发病率分别为0.07 （N= 5）和0.21 (N= 13)，全因死亡率分别为0.91 （N= 61）和1.10 （N= 67）。在考虑年龄、性别和干预前COVID-19率的模型中，干预村与对照村COVID-19病例的比率为0.96(95%可信区间0.57至1.63)，COVID-19住院率为0.36(95%可信区间0.12至1.05)，全因死亡率为0.84（0.55至1.29）。无不良反应报告。解释：由于事件数量较少，导致效果估计不准确，因此我们无法从这些数据中得出关于在村庄范围内分发和推广口罩对COVID-19发病率的影响的确切结论。尽管如此，我们的研究结果与之前的随机试验中对意外病例的适度保护作用一致，首次将其扩展到不良结果。资助：印度协同基金会。注册：该试验已于2020年7月25日在印度临床试验注册中心（CTRI/2020/07/026796）预注册。

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来源期刊

Journal of Infection 医学-传染病学

CiteScore

45.90

自引率

3.20%

发文量

475

审稿时长

16 days

期刊介绍： The Journal of Infection publishes original papers on all aspects of infection - clinical, microbiological and epidemiological. The Journal seeks to bring together knowledge from all specialties involved in infection research and clinical practice, and present the best work in the ever-changing field of infection. Each issue brings you Editorials that describe current or controversial topics of interest, high quality Reviews to keep you in touch with the latest developments in specific fields of interest, an Epidemiology section reporting studies in the hospital and the general community, and a lively correspondence section.