Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: An Integrated mHealth Approach

NCT ID: NCT04865276

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2027-07-31

Brief Summary

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We developed and established the efficacy of a theory-based, culturally- and gender-relevant Community Health Worker (CHW) intervention for low-income Brazilian women that augments the tobacco cessation program offered through the public health system. This study represents the continuation of our gender-relevant tobacco control efforts in Brazil by proposing the adaptation of this CHW-delivered tobacco cessation program to be integrated with mHealth support through mobile devices (App). We are proposing an integrated CHW-mHealth application that (a) is culturally- and gender-relevant, (b) is theory-based (Social Cognitive Theory), (c) considers the existing structure of the Brazilian health care system, and (d) will be adapted based on an efficacious intervention as well as salient features of other mHealth applications that have been shown to be successful in engaging users. During phase I we will make the adaptations and determine feasibility of a CHW-delivered intervention that is integrated with a mHealth tobacco cessation application (interactive App for participants and tracking system for CHWs) through formative assessments among all involved stakeholders, pretesting, and pilot testing of the intervention. In phase II we will assess the effectiveness of the integrated CHW-mHealth tobacco cessation intervention through a group randomized trial with towns as the unit of randomization (8 towns, N=344). The comparison group will be the same as the previous intervention (consisting of a home visit by a CHW during which the participant is scheduled to attend the tobacco cessation program at the neighborhood public health clinic) to allow for comparisons. We hypothesize that at 6-months, women smokers who receive the integrated CHW-mHealth intervention will have significantly higher 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days) than women smokers in the control condition. Self-report will be verified through measurement of exhaled carbon monoxide levels among 30% of participants. If shown to be effective, this approach could be utilized as a model for a population-based intervention in low-resource settings, including rural and disadvantaged women in the U.S.

Detailed Description

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Conditions

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Tobacco Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system

Group Type ACTIVE_COMPARATOR

Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system

Intervention Type BEHAVIORAL

Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system

Control

Home visit by a Community Health Worker during which the participant is scheduled to attend the tobacco cessation program at the public health system

Group Type ACTIVE_COMPARATOR

Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system

Intervention Type BEHAVIORAL

Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system

Interventions

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Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system

Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age
* Current tobacco use
* Willingness to quit tobacco use
* resident in the town assigned to intervention or control

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Estadual de Londrina

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Isabel Scarinci

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabel C Scarinci, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Universidade Estadual de Londrina

Londrina, ParanĂ¡, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Isabel C Scarinci, PhD

Role: CONTACT

(205) 975-7177

Facility Contacts

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Nadia Kienen, PhD

Role: primary

Other Identifiers

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IRB-300007350

Identifier Type: -

Identifier Source: org_study_id

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