Health Condition 1: J628- Pneumoconiosis due to other dust containing silica Health Condition 2: A159- Respiratory tuberculosis unspecified
Conditions
Interventions
Intervention1: 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 ser
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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.Timepoint: 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.Timepoint: 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 ar | — |
Countries
India
Contacts
Public ContactDr Mihir P Rupani
ICMR - NIOH, Ahmedabad
Outcome results
None listed