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

Tobacco Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04865276
• Other study ID #: IRB-300007350
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: September 2023
• Source: University of Alabama at Birmingham
• Contact: Isabel C Scarinci, PhD
• Phone: (205) 975-7177
• Email: scarinci[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 344
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Cessation

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Londrina	Londrina	Paraná

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence (defined as no cigarettes in the past 7 days)		6 months