Promoting tobacco cessation in low-resource communities in Mumbai, India
LifeFirst Supporting Wellbeing Among Adults by Stopping Tobacco Habit
This study is trying out a new way to help adults in low-resource communities in Mumbai quit using tobacco by giving them simple advice and support without expensive medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4820 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Harvard School of Public Health (HSPH) Academic / other |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT05234983 on ClinicalTrials.gov |
What this trial studies
This initiative focuses on encouraging tobacco cessation among adults in underserved community settings in Mumbai, India. It employs a brief advice intervention that includes screening for tobacco use, advising individuals to quit, and referring them to available treatment options, all without the use of costly pharmacotherapy. The program aims to be implemented in various community healthcare settings, such as TB treatment clinics and NGO-run health centers, utilizing a task-shifting model to enhance delivery. The goal is to create a sustainable and scalable approach to tobacco cessation in low-resource environments.
Who should consider this trial
Good fit: Ideal candidates for this initiative are adults aged 18 and over who use smokeless or smoked tobacco and are attending the practice of an enrolled practitioner.
Not a fit: Patients currently participating in other tobacco cessation programs or those without access to a mobile phone may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce tobacco use and related health issues in low-resource populations.
How similar studies have performed: Other studies have shown success with similar brief advice interventions in various settings, indicating potential for effectiveness in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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)
Where this trial is running
Mumbai, Maharashtra
- Narotam Sekhsaria Foundation — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Himanshu Gupte, MBBS, MD — Narotam Sekhsaria Foundation
- Study coordinator: Vish Viswanath, PhD
- Email: vish_viswanath@dfci.harvard.edu
- Phone: 617-632-2225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.