Improving detection and treatment outcomes of tuberculosis and silicosis through bidirectional screening intervention among stone carving workers in Sirohi district, Rajasthan: an implementation research study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The primary outcome variable would be the proportion of screened TB patients diagnosed as silicosis under the TB-silicosis bidirectional screening initiative. Also, another primary outcome variable would be the proportion of screened silicosis patients/silica-exposed workers diagnosed with TB under the initiative.
研究概览
简要总结
Rationale: Impact of TB-silicosis bidirectional screening on improving detection and treatment outcomes of TB among stone carving workers is not known.
Novelty: First implementation research among stone carving workers on improved detection and its possible impact on TB treatment outcomes through bidirectional screening.
Objectives: To determine impact of TB-silicosis bidirectional screening on improved detection and treatment outcomes of TB/silicosis and explore its implementation challenges, to determine burden of latent TB infection, to determine predictors of TB in relation to respirable silica dust levels among stone carving workers, and to determine predictors of TB treatment failure with a focus on serum levels of anti-TB drugs.
Methods: We would be conducting mixed-methods quasi-experimental study among stone carving workers in two CHCs (intervention vs. comparison) of Sirohi. Baseline survey would be carried out. In intervention CHC, all patients with TB working in stone carving industry would be referred for diagnosis of silicosis; while all stone carving workers with TB symptoms and with silicosis would be referred for diagnosis of TB. Bidirectional screening would not be implemented in comparison CHC. Patients with TB would be followed up passively for treatment outcomes, which would be compared between the two CHCs. On a sample of study participants, latent TB infection, silica dust concentration, and serum levels of anti-TB drugs would be measured. In-depth interviews would be conducted to explore implementation challenges and role of therapeutic drug monitoring.
Expected outcomes: Study would provide insights on effectiveness of implementing TB-silicosis bidirectional screening on TB treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Tuberculosis patients who are:
- •Working as stone-carving workers
- •Adults (≥18 years of age)
- •Put on treatment at CHC Pindwara
- •Diagnosed with pulmonary TB
- •Either newly diagnosed or re-treated Stone-carving workers who are/were:
- •Diagnosed with silicosis (past or current)
- •Currently suffering from any one of the following symptoms: cough, fever, weight loss, or hemoptysis (of any duration).
排除标准
- •Tuberculosis patients who are:
- •Already diagnosed with silicosis (silico-tuberculosis)
- •Not providing written informed consent to participate in the study Stone-carving workers who are:
- •Already diagnosed with TB or silico-tuberculosis
- •Not providing written informed consent to participate in the study.
结局指标
主要结局
The primary outcome variable would be the proportion of screened TB patients diagnosed as silicosis under the TB-silicosis bidirectional screening initiative. Also, another primary outcome variable would be the proportion of screened silicosis patients/silica-exposed workers diagnosed with TB under the initiative.
时间窗: 12 months
次要结局
- The secondary outcome variable would be the treatment outcomes of TB which would be compared between the intervention vs. comparison PHCs. Treatment success is defined when the patients test negative on sputum/culture at the end of treatment (termed as ‘cured’) or, have completed treatment without any evidence of clinical or radiological deterioration (defined as ‘treatment completed’). ‘Unfavorable TB treatment outcomes’ are defined when patients are categorized as ‘lost to follow-up’ (stopped treatment for at least one consecutive month), test positive on sputum/culture at the end of treatment (termed as ‘treatment failure’), died while on treatment (categorized as ‘died’). The secondary outcome variable would be dichotomous, with unfavorable vs. successful treatment outcomes.(12 months)
- The outcome variable would be prevalence of latent TB infection among stone carving workers (dichotomous variable). The predictor variables would be age, gender, levels of silica dust, number of years of exposure to silica dust, previous diagnosis of TB, body mass index, and others.(24 months)
- The primary outcome variable would be active TB disease (presence or absence of it - dichotomous variable). The exposure variable would be the levels of silica dust concentration to which the stone carving workers are exposed to. The confounding variables would be age, gender, smoking, alcohol consumption, HIV, diabetes, number of years of exposure to silica dust, number of years of education, standard of living index, previous diagnosis of TB, body mass index, and others.(30 months)
- The primary outcome variable would be the occurrence of TB treatment failure (defined as a patient whose sputum is positive for TB at the end of treatment) which will be dichotomous. The secondary outcome variable would be the serum level of Isoniazid (H) and Rifampicin (R) drugs, which will be dichotomized as normal if they fall within or above the expected range, or as low if they are below the expected range. The exposure variable would consist of silico-tuberculosis patients (patients diagnosed with both silicosis and TB), whereas the comparison group would consist of TB patients without silicosis. Several confounding variables would be taken into account, such as age, gender, alcohol consumption, gastrointestinal disorders, HIV, diabetes, pregnancy, hepatic disease, renal disease, drug consumption and others.(30 months)
研究者
Dr Mihir P Rupani
ICMR - NIOH, Ahmedabad