Protocol for the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial
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Le résumé fourni par la source
INTRODUCTION: The use of tobacco remains a significant health concern among people with HIV (PWH) in India, exacerbating comorbidities, increasing the risk of HIV-related complications and reducing the effectiveness of antiretroviral therapy. This protocol outlines a randomized trial designed to evaluate the effectiveness, cost and implementation of a tobacco cessation intervention for PWH in India. METHODS: This is a type 1 hybrid implementation effectiveness study including a clinical trial (n = 400) randomizing adults who smoke 1:1 to varenicline and Positively Smoke Free Mobile (PSF-M), a theory-based, digital, behavioral intervention versus a standard care control of brief cessation advice and Quitline referral. The primary outcome is cotinine-validated 7-day point prevalence abstinence from tobacco at 24 weeks post-randomization. Implementation outcomes of acceptability, adoption, appropriateness, feasibility, fidelity, penetration, and sustainability will be measured by survey and interviews. Cost-effectiveness of the intervention will be calculated using a simulation model of tobacco and nicotine outcomes. CONCLUSION: This study will test the effectiveness of a scalable and comprehensive tobacco use treatment approach with medication plus digital behavioral support in a low- and middle-income country setting, paired with examination of implementation and cost-effectiveness. This research has the potential to improve the health of PWH by demonstrating the health effects of a tobacco cessation treatment package that aims to reduce the morbidity and mortality associated with smoking. Trial Registration clinicaltrials.gov #NCT05786547, Registered 27 March 2023.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Protocol for the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial
- Date Crossref
- 01/01/2026
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Colorado Anschutz Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Voluntary Health Services Hospital pays non établi dans la noticeÉtablissement de santé
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Albert Einstein College of Medicine Department of Medicine and Department of Epidemiology and Population Health pays non établi dans la noticeUniversité ou école supérieure
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Massachusetts General Hospital Tobacco Research and Treatment Center pays non établi dans la noticeÉtablissement de santé
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University of Michigan Center for Health Communications Research pays non établi dans la noticeUniversité ou école supérieure
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Chennai Antiviral Research and Treatment Clinical Research Site Voluntary Health Services Infectious Diseases Medical Centre pays non établi dans la noticeÉtablissement de santé
Department of Medicine — University of Colorado Anschutz, Voluntary Health Services Hospital et Department of Medicine and Department of Epidemiology and Population Health — Albert Einstein College of Medicine, avec 3 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.