The aim of the study is to determine the impact of a package of smoking-cessation interventions on a composite measure of Tuberculosis (TB) treatment-related outcomes. Given the lack of objective clinical data/evidence about the impact of smoking-cessation on TB-related outcomes, yet subjective expert opinion that smoking cessation is highly likely to be beneficial particularly in patients with TB, this study proposes to determine the impact of an intensive package of smoking-cessation interventions aimed to promote smoking-cessation (counseling plus nicotine replacement therapy, NRT), on patient response to anti-tuberculosis therapy. This is to be compared with the structured counselling for smoking-cessation that is recommended to be routinely provided by health care workers to all patients who are smokers. If the results prove that such a smoking-cessation PI indeed improves outcomes in TB patients, such information would strongly motivate for the institution of more intensive smoking-cessation interventions in TB clinics than is currently being employed for TB patients
No clinical trials have been done to determine if the cessation of smoking has any influence on outcome in tuberculosis patients. In particular, if smoking cessation leads to a higher rate of sputum culture-conversion at 2 months, TB transmission rates should be reduced. Such targeted smoking-cessation intervention may be more successful than general public education strategies in reducing the spread of TB in high-incidence countries Tuberculosis (TB) . The WHO has estimated that approximately a third of the world's population is infected with Mycobacterium tuberculosis, and approximately 2 million die from TB every year. Tobacco smoking, which is the single most preventable cause of death in the world today, appears to be an important risk factor for TB disease and mortality, especially in countries such as India. The smoking-TB association has major public health implications because in many of the developing countries where there is a high prevalence of TB, smoking is also a common practice. Smoking is widespread, with approximately a third of the global population aged 15 years or above being smokers, but has reached epidemic proportions in countries such as India, China and Russia. For example, in India more than half of the rural male population is estimated to smoke and India accounts for 1.85 million TB cases each year. Therefore in India, as for other developing countries, the co-existence of a high TB and smoking burden is a major health concern, and further underscores the importance of promoting smoking cessation to the general public. In India, studies have shown a strong association between tobacco and TB mortality. An estimated third of male TB deaths in India may be due to smoking. However, there is concern that many of the published studies did not adequately control for bias and confounding (that may have caused spurious associations).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
800
nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
All India Institute of Medical Sciences, Ansari Nagar
New Delhi, India
1. Change in TB Score at second month and sixth month
Composite score for objective and subjective improvement measured at baseline, second month and sixth month
Time frame: Measured at baseline, second month and sixth month.
Sputum culture conversion
Sputum culture conversion at second month using solid/liquid culture technique
Time frame: Measured at baseline and second month
Sputum smear conversion
Protocol was amended to access sputum conversion weekly up to second month
Time frame: Measured at baseline, second week, fourth week, second month and sixth months
Mortality at sixth month
To determine number of mortality at the end of follow-up
Time frame: Sixth month
More than 10% weight gain at six months
To determine rate of weight gain after completion of treatment
Time frame: Sixth month
Proportion of subjects in each group that have quit smoking at second month
To determine the rate of smoking cessation in the cohort
Time frame: Sixth month
Treatment completion
Time frame: Six months for new cases and eight months for re-treatment cases following regimen 2
Cure, failure and default rate
To determine cure, failure and default rate in the cohort
Time frame: At sixth month
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