Silicosis and Silicotuberculosis Among Small Scale Gemstone Miners in Northern Tanzania: SilicoTB
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Change in chest radiography
研究概览
简要总结
Artisanal, small-scale mining (ASM) is a large and essential component of the world's economy. Despite attendant risks, there is little research into risks to the health of artisanal miners. The tanzanite gemstone is mined exclusively in Northern Tanzania, in deep shafts using ASM techniques. There is concerning evidence that the burden of silicosis and tuberculosis (TB) amongst miners is high. In addition to miners' personal risks, there is concern that a high rate of silicotuberculosis may hamper community control of TB.
Our primary aim is to measure the rate of silicosis progression among tanzanite miners. Our secondary aims include measuring the prevalence of TB among miners, describing TB transmission patterns in miners and the community, and assessing rates of 'catastrophic' economic loss amongst miners.
To do this, the investigators propose two studies. First, the investigators will establish a prospective cohort of 410 small scale tanzanite miners and record symptoms, respiratory function including spirometry, chest radiography, and prevalence of TB and Human Immunodeficiency Virus (HIV) infection over an 18-month period. Second, the investigators will utilize an ongoing community-based TB screening program to perform a cross-sectional survey of TB prevalence among miners and community members. To assess TB transmission, the investigators will collect epidemiological data and perform whole genome sequencing (WGS) on positive Mycobacterium tuberculosis (MTb) culture samples.
Given the lack of research and large global ASM workforce, 1 million of whom are in Tanzania, the results of this study will assist in the development and introduction of interventions to reduce the risks to respiratory health of artisanal mining in Tanzania and elsewhere; and provide ample scope for future work.
详细描述
Background Artisanal and small-scale mining (ASM) produces a quarter of the global supply of key metals for the electronics industry and provides direct employment for an estimated 45 million people. Approximately 10 million are in sub-Saharan Africa (SSA), of whom over 1 million work in Tanzania. ASM is characterized by occupational insecurity and low levels of safety and environmental protection, but there is little research into its risks, particularly respiratory and communicable diseases.
Silicosis is an occupational respiratory disease caused by inhalation of respirable crystalline silica (RCS). It usually presents irreversibly after decades of exposure, although accelerated disease associated with high initial exposures can lead to respiratory failure within 1-2 years. To date, silicosis has been examined in only two ASM populations: in Brazil, where radiographic evidence was reported in 37% of 348 current and ex-miners, and in Zimbabwe, where a prevalence of 11% was reported among 514 current miners.
Silicosis and RCS exposure increase the risk of pulmonary tuberculosis (PTB). In miners with silicosis, human immunodeficiency virus (HIV) is also known to multiplicatively increase the risk of TB. Correspondingly, a high PTB prevalence of between 3% to 14% has been reported in several studies of sub-Saharan African ASM workers. The role of miners in community PTB transmission is of considerable public health importance but remains unclear; whole genome sequencing (WGS) is the most accurate available method for assessing this. HIV prevalence across small-scale mining populations ranges from 1.8-18%. The role of HIV in the development and progression of silicosis is unclear and requires further study, with conflicting evidence on whether it reduces or increases the risk of silicosis.
The World Health Organization (WHO) provides a strong recommendation for screening among silica-exposed populations. This recommendation is based on an estimated number needed to screen of 36 in high incidence settings and an increased mortality from TB amongst miners with silicosis, with a corresponding 82% reduction in mortality in screened compared to unscreened miners with TB. Despite this recommendation, there is limited evidence, particularly from Sub-Saharan Africa and in the last two decades, of optimized methods for doing this. Beyond screening, differentiating silicosis, tuberculosis, and silicotuberculosis is clinically challenging, leading to misclassification across all diagnoses. Symptoms are common among miners; for example, in ASM TB screening studies, between 23-39% meet symptomatic criteria for presumptive TB. There is also a growing appreciation that subclinical TB is common and plays an important role in transmission. A screening tool that, either alone or in tandem with current approaches, improves the sensitivity and specificity for TB would be useful diagnostically and programmatically, potentially allowing allocation of resources towards higher risk individuals. One recently investigated method which has shown promise in meeting the WHO target product profile of 90% sensitivity and 70% specificity for a triage tool is C-reactive protein (CRP). CRP testing can be performed at the point of care for less than $2-3. Most recently, WHO guidance has recommended CRP (with a threshold of >5mg/L) may be used in screening for TB disease among adults and adolescents living with HIV.
The tanzanite gemstone is mined exclusively in a 5x2 km strip of land in Mererani, Northern Tanzania. Miners use deep shafts and basic techniques. Three sources of evidence raise concern that the burden of silicosis and PTB among the estimated 9,000-12,000 ASM tanzanite miners is high. First, a recent cross-sectional survey of 330 miners estimated a silicosis prevalence of 30% on chest radiograph and a microbiologically confirmed PTB prevalence of 6% among miners and 8% in the surrounding community. Miners had a median age of 35 years and just 5 years of employment. Second, a case series from the local tertiary referral hospital found a primary diagnosis of silicosis or silicotuberculosis made up 22% of respiratory admissions; over half were under 45 years old and 63% required oxygen therapy. Third, in an occupational clinic for miners and their families, 22% of 315 miners had silicosis on chest X-ray (CXR) and 18% of 243 tested had confirmed PTB.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in chest radiography
时间窗: 18-months
Rate of change of the ILO classification of pneumoconioses among cohort participants
次要结局
- Drug resistance patterns among positive TB cultures(18-months)
- Silicosis prevalence at baseline(Baseline)
- Measurement of 'catastrophic' economic loss(18-months)
- TB prevalence at baseline(Baseline)
- Clustering of TB cases(18-months)
- Use of C-reactive protein as a screening aid for TB(Baseline)
研究者
Dr Patrick Howlett
Doctor Clinical Research Fellow
National Heart and Lung Institute
