Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 8, 2024
Date Accepted: Jul 9, 2024
Adapting and evaluating a brief advice tobacco cessation intervention in high-reach, low-resource settings in India: Protocol for a cluster-randomized controlled trial
ABSTRACT
Background:
About 1.35 million deaths are attributed to tobacco use in India each year. The main challenge, given the magnitude of tobacco use and limited resources, is delivering cessation supports at scale, at low cost, and through a coordinated effort across systems. One type of low-cost, scalable cessation support is brief advice interventions, or short engagement by healthcare providers to screen for tobacco use, offer cessation advice, and refer users to treatment resources. However, there are limited numbers of highly-credentialed staff to identify and counsel tobacco users. Task-shifting, or the use of diverse health professionals, is an important opportunity for scaling brief advice interventions.
Objective:
A team at Narotam Sekhsaria Foundation (NSF) in Mumbai, India developed and implemented LifeFirst, an evidence-informed tobacco cessation program involving cessation services in settings like hospitals and workplaces. This program has been adapted to develop LifeFirst SWASTH (Supporting Wellbeing among Adults by Stopping Tobacco Habit) which focuses on lower-socioeconomic status (SES) communities in Mumbai who receive healthcare through private dental practices and non-governmental organizations (NGOs), including those working with tuberculosis (TB) patients. The objective of this cluster randomized controlled trial (RCT) is to assess whether the adapted brief advice program results in increased cessation rates among tobacco users in low-resource, high-reach healthcare settings in Mumbai compared to usual care.
Methods:
This study is a parallel-arm cluster RCT. The study sites will be TB-specific NGOs, dental clinics, and NGOs implementing general health programs that serve lower-SES patients. Intervention-arm patients will receive a pamphlet about the harmful effects of tobacco. Practitioners will be trained to deliver brief advice about cessation, and interested patients will be referred to an NSF counselor for free telephone counseling for six months. Control-arm patients will receive the same pamphlet but not brief advice or counseling. (They will be offered counseling after the study concludes.) Practitioners will have access to a customized mobile application (app) to facilitate intervention delivery. Practitioners will also have access to a peer network through the platform WhatsApp. The primary outcome is 30-day point prevalence abstinence (PPA) from tobacco. Secondary outcomes for patients and practitioners relate to intervention implementation.
Results:
Recruitment for the RCT commenced in November 2023.
Conclusions:
LifeFirst SWASTH, if found to be effective in terms of cessation outcomes and implementation processes, has the potential to be scaled to other settings in India and other low- and middle-income countries (LMICs). The study will be conducted in low-resource settings that will reach many patients, which will increase the impact if scaled. It will employ task-shifting and an app that can be tailored to different settings, also enabling scalability. Additionally, findings will build the literature for translating EBIs from high-income countries to LMICs and from high- to low-resource settings. Clinical Trial: ClinicalTrials.gov NCT05234983
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