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CTRI Number  CTRI/2025/01/079278 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Other 
Public Title of Study   Health screening and treatment for lung diseases (tuberculosis and silicosis) in stone-carving workers exposed to silica dust in Rajasthan: A study to improve early detection and care 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mihir P Rupani 
Designation  Scientist-E (Medical) 
Affiliation  ICMR - NIOH, Ahmedabad 
Address  ICMR-National Institute of Occupational Health, Meghani nagar, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9925222421  
Fax    
Email  mihir.rupani@icmr.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mihir P Rupani 
Designation  Scientist-E (Medical) 
Affiliation  ICMR - NIOH, Ahmedabad 
Address  ICMR-National Institute of Occupational Health, Meghani nagar, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9925222421  
Fax    
Email  mihir.rupani@icmr.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Mihir P Rupani 
Designation  Scientist-E (Medical) 
Affiliation  ICMR - NIOH, Ahmedabad 
Address  ICMR-National Institute of Occupational Health, Meghani nagar, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9925222421  
Fax    
Email  mihir.rupani@icmr.gov.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR), New Delhi, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research, V. Ramalingaswami Bhawan, PO Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mihir Prafulbhai Rupani  Community health center Pindwara  Forest colony, Pindwara, SH-62, Sirohi road, Sirohi district, Rajasthan 307023.
Sirohi
RAJASTHAN 		 9925222421

mihirrupani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ICMR National Institute of Occupational Health Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J628||Pneumoconiosis due to other dust containing silica, (2) ICD-10 Condition: A159||Respiratory tuberculosis unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Counseling on TB and silicosis risks for silica-exposed workers  The CHC Swaroopganj would act as the comparison group which would not receive the TB-silicosis bidirectional screening intervention. Workers exposed to silica dust will receive counseling on the health risks of TB and silicosis, including symptoms, prevention, and the importance of early detection. The sessions aim to promote awareness and encourage proactive health-seeking behavior. Although, all 1000 stone carving workers in CHC Swaroopganj would be line-listed and would be followed up for incidence of TB and silicosis. The treatment outcomes of TB would also be obtained from the Nikshay online portal. 
Intervention  TB-silicosis bidirectional screening  The TB-silicosis bidirectional screening intervention will be implemented in CHC Pindwara for a period of 12 months, while CHC Swaroopganj will serve as the comparison CHC without any intervention. The intervention will involve the diagnosis and management of silicosis among stone carving workers undergoing TB treatment, as well as the diagnosis and treatment of TB among stone carving workers diagnosed with silicosis or presenting TB symptoms. The detailed frameworks for the intervention are provided as PDF attachments in the annexures (Figures 1 and 2). Figure 1 describes the diagnosis and management of silicosis among stone carving workers with TB. Stone carving workers undergoing TB treatment at CHC Pindwara will be asked about their occupation. Those working in the stone carving industry will be referred by the medical officer for registration on the Silicosis online portal of Rajasthan through the Atal Seva Kendra linked with Jan Aadhaar. The workers will receive an SMS notification requesting them to undergo a chest X-ray at CHC Pindwara. The X-ray images will be uploaded onto the Computerized Radiography system, where a blinded radiologist will provide the diagnosis of silicosis. Figure 2 outlines the diagnosis and management of TB among stone carving workers. A survey will be conducted among stone carving workers to identify those experiencing TB symptoms, such as fever, cough, weight loss, and hemoptysis. Symptomatic individuals will be referred to CHC Pindwara for TB diagnosis under the National Tuberculosis Elimination Program (NTEP). Additionally, stone carving workers diagnosed with silicosis within the area under CHC Pindwara will be counseled for TB diagnosis. Those willing to get diagnosed with TB will be referred to CHC Pindwara for NTEP-based TB diagnosis. The research team will passively follow up with the identified TB patients to monitor their treatment outcomes, which will be extracted from the Nikshay online portal. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Tuberculosis patients who are:
1. Working as stone-carving workers
2. Adults (≥18 years of age)
3. Put on treatment at CHC Pindwara
4. Diagnosed with pulmonary TB
5. Either newly diagnosed or re-treated

Stone-carving workers who are/were:
1. Diagnosed with silicosis (past or current)
2. Currently suffering from any one of the following symptoms: cough, fever, weight loss, or hemoptysis (of any duration) 
 
ExclusionCriteria 
Details  Tuberculosis patients who are:
1. Already diagnosed with silicosis (silico-tuberculosis)
2. Not providing written informed consent to participate in the study

Stone-carving workers who are:
1. Already diagnosed with TB or silico-tuberculosis
2. Not providing written informed consent to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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. 
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