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

NCT05234983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4693

Last updated 2026-02-27

No results posted yet for this study

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

Interventions

BEHAVIORAL

LifeFirst SWASTH brief advice intervention

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.

Sponsors & Collaborators

  • Dana-Farber Cancer Institute

    collaborator OTHER
  • Narotam Sekhsaria Foundation, India

    collaborator UNKNOWN
  • Boston University

    collaborator OTHER
  • Dimagi Inc.

    collaborator INDUSTRY
  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Himanshu Gupte, MBBS, MD · Narotam Sekhsaria Foundation

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-07-22
Completion
2025-09-18

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234983 on ClinicalTrials.gov