Status:
ACTIVE_NOT_RECRUITING
Adapting and Evaluating a Brief Advice Tobacco Intervention in High-Reach, Low-Resource Settings in India
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Dana-Farber Cancer Institute
Narotam Sekhsaria Foundation, India
Conditions:
Tobacco Use Cessation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to promote tobacco cessation among adults in high-reach, low-resource community settings in Mumbai, India. Tobacco use is a major driver of cancer deaths and as of 2017, about 267 mill...
Detailed Description
Background and Significance: About 1 million deaths are attributed to tobacco use in India each year. In 2017 there were roughly 267 million tobacco users including 199 million smokeless tobacco user...
Eligibility Criteria
Inclusion
- Practitioner inclusion criteria:
- targeted workers from targeted settings
- sufficient language proficiency in English and/or Hindi to attend the training and take surveys
- has not received prior in-depth LifeFirst training
- can recruit 10-60 tobacco users in a six-month period
- works in a setting in which brief advice can be added to the workflow
- delivers care in Greater Mumbai and expects to do so for one year post-training
- can secure institutional signoff to participate and utilize the program in practice
- has an Android smartphone
- Patient inclusion criteria:
- user of smokeless and / or smoked tobacco
- age 18 and over
- attending the practice of an enrolled practitioner
- has a mobile phone (required for data collection)
- does not have another member of their household participating in the study
- is not currently participating in any tobacco cessation program (such as through the National Quitline)
Exclusion
- Practitioner exclusion criteria:
- does not work in one of the targeted settings
- works in one of the targeted settings but is not a targeted worker
- does not have sufficient language proficiency in English and/or Hindi to attend the training and take surveys
- has received prior in-depth LifeFirst training
- cannot recruit 36 tobacco users in a six-month period
- does not work in a setting in which brief advice can be added to the workflow
- does not deliver care in Greater Mumbai
- delivers care in Greater Mumbai but does not expect to do so for one year post-training
- cannot secure institutional signoff to participate and utilize the program in practice
- does not have an Android smartphone
- Patient exclusion criteria:
- not a user of smokeless or smoked tobacco
- under age 18
- does not attend the practice of an enrolled practitioner
- does not have a mobile phone
- has another member of their household participating in the study
- is currently participating in any tobacco cessation program (such as through the National Quitline)
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
4820 Patients enrolled
Trial Details
Trial ID
NCT05234983
Start Date
November 1 2023
End Date
October 1 2025
Last Update
September 16 2025
Active Locations (1)
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1
Narotam Sekhsaria Foundation
Mumbai, Maharashtra, India, 400 021