Adapting and Evaluating a Brief Advice Tobacco Intervention in High-Reach, Low-Resource Settings in India

NCT05234983 | Completed

• 1 other identifier: R01CA230355
• Study Type: interventional
• Target: 4,693
• Locations: 1 country
• Sites: 1

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 million individuals use smokeless and/or smoked tobacco in India. One of the WHO-endorsed evidence-based practices for tobacco cessation is brief advice interventions, which involve screening for tobacco use, advising patients to quit, and referring them to treatment. While these interventions often include medication for tobacco cessation in higher-income countries, such treatments can be an expensive and impractical solution in low- and middle-income countries. The team proposes a simplified brief advice intervention without the use of pharmacotherapy, to be implemented in community-based healthcare settings in Mumbai (TB treatment clinics, NGO-run health centers, and dental practices serving populations of lower-socioeconomic status). A task-shifting model will be used, moving program delivery responsibilities from clinicians to community health practitioners. The team also proposes to use a mobile app and a WhatsApp group to support ongoing training and engagement of practitioners. The central questions are: Does a brief advice intervention adapted for use in low-resource settings in India through task-shifting and technology-based training support result in higher cessation rates than usual care? What are the key barriers to and facilitators of program implementation? The study has three aims: Aim 1: Adapt and pilot-test a tobacco cessation evidence-based program in three types of low-resource community-based healthcare settings in Mumbai. Aim 2: The clinical trial itself involves assessing whether the adapted brief advice program results in increased quit rates among tobacco users (compared to usual care) in three types of healthcare settings. The hypothesis is that those assigned to the brief advice program will be more likely to have maintained tobacco cessation after 6 months compared to those who received usual care. Aim 3: Evaluate the use of communication technologies, such as social media and apps, to support ongoing training and networking among practitioners who are implementing the intervention. The long-term goal is to support adaptation and scale-up of tobacco control EBPs from high-resource to low-resource settings. Towards that goal, the overall objective is to develop a scalable, resource-appropriate brief advice EBP for use in India.

Conditions

Tobacco Use Cessation

Keywords

Medically underserved population; Implementation science; Tobacco use

Outcome Measures

Primary Outcomes (6)

• Duration of abstinence from tobacco use

  The team will adapt the Russell Standard, an established measure of smoking cessation, for use in our population, in which smokeless tobacco is an important form of tobacco use.

  7-days post-recruitment

• Duration of abstinence from tobacco use

  The team will adapt the Russell Standard, an established measure of smoking cessation, for use in our population, in which smokeless tobacco is an important form of tobacco use.

  1-month post-recruitment

• Duration of abstinence from tobacco use

  The team will adapt the Russell Standard, an established measure of smoking cessation, for use in our population, in which smokeless tobacco is an important form of tobacco use.

  3-months post-recruitment

• Duration of abstinence from tobacco use

  The team will adapt the Russell Standard, an established measure of smoking cessation, for use in our population, in which smokeless tobacco is an important form of tobacco use.

  6-months post-recruitment

• Self-reported abstinence from tobacco use

  The team will ask patients a standard question, modified for smokeless tobacco use inclusion, "Have you used tobacco at all since (start date of abstinence period)?" For those who report that they have not used any form of tobacco at the 6-month follow-up, the team will conduct a biochemical verification.

  6-months post-recruitment

• Biochemical verification of tobacco cessation

  Self-report regarding tobacco cessation may yield an over-reporting of abstinence, and the team will verify abstinence through testing of an established marker of tobacco use - cotinine, a primary metabolite of nicotine. For biochemical verification, the team will utilize a saliva-based test from Salimetrics, which uses a cotton stick that is chewed by the patient for two minutes, placed into a tube, and then transported to a laboratory for analysis using Enzyme-Linked Immuno Sorbent Assay. Following the Society for Nicotine and Tobacco Research guidelines, the cutoff will be 15 ng/mL, but the team will also conduct sensitivity analyses at 12 and 20 ng/mL.

  6-months post-recruitment

Secondary Outcomes (29)

• Quit attempts

  7-days post-recruitment

• Quit attempts

  1-month post-recruitment

• Quit attempts

  3-months post-recruitment

• Quit attempts

  6-months post-recruitment

• Reduction in tobacco use

  7-days post-recruitment

Study Arms (2)

LifeFirst SWASTH brief advice intervention

EXPERIMENTAL

Described in the "Intervention Description" section

Behavioral: LifeFirst SWASTH brief advice intervention

Control: Educational pamphlets

NO INTERVENTION

In lieu of the intervention, participants will receive a high-quality evidence-based pamphlet tobacco cessation pamphlet created by the NSF team for low-SES audiences in Mumbai. After all data has been collected, community healthcare settings in the control arm will have the opportunity to receive the intervention.

Interventions

LifeFirst SWASTH brief advice intervention BEHAVIORAL

This intervention will support tobacco cessation among patients of high-reach, low-resource community healthcare settings in Mumbai (TB clinics, dental practices, and NGO-run health centers). The intervention will also use technology to build the capacity of practitioners in these settings to use evidence-based practices in their work and allow them to network and exchange best practices with one another.

LifeFirst SWASTH brief advice intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Dana-Farber Cancer Institute: collaborator
• Narotam Sekhsaria Foundation, India: collaborator
• Boston University: collaborator
• Dimagi Inc.: collaborator

Study Sites (1)

Narotam Sekhsaria Foundation

Mumbai, Maharashtra, 400 021, India

Location

Related Publications (3)

• Mahtani SL, Viswanath K, Gupte HA, Mandal G, Jagiasi D, Chawla R, D'Costa M, Xuan Z, Minsky S, Ramanadhan S. Adapting and Evaluating a Brief Advice Tobacco Cessation Intervention in High-reach, Low-resource Settings in India: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 3;13:e57236. doi: 10.2196/57236.

  PMID: 39225384 BACKGROUND

• Gupte HA, D'Costa M, Ramanadhan S, Viswanath K. Factors Influencing Implementation of a Workplace Tobacco Cessation Intervention in India: A Qualitative Exploration. Workplace Health Saf. 2021 Feb;69(2):56-67. doi: 10.1177/2165079920952761. Epub 2020 Dec 13.

  PMID: 33308086 BACKGROUND

• Ramanadhan S, Xuan Z, Choi J, Mahtani SL, Minsky S, Gupte H, Mandal G, Jagiasi D, Viswanath K. Associations between sociodemographic factors and receiving "ask and advise" services from healthcare providers in India: analysis of the national GATS-2 dataset. BMC Public Health. 2022 Nov 18;22(1):2115. doi: 10.1186/s12889-022-14538-2.

  PMID: 36401241 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Himanshu Gupte, MBBS, MD

  Narotam Sekhsaria Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Social and Behavioral Sciences

Model Details: The intervention will consist of training for practitioners (2 half-days), supportive material via a mobile app, peer networking via social media, and technical assistance to deliver the intervention. The practitioners will then deliver brief advice to patients in the practice setting. Interested patients will then receive follow- up counseling by an NSF-Mumbai counselor via phone. For those who do not receive the intervention, the patients will be provided educational pamphlets. The control arm will have the opportunity to receive the intervention later on (delayed start).

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 10, 2022
• Study Start: November 1, 2023
• Primary Completion: July 22, 2025
• Study Completion: September 18, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)