Gender-Relevant Tobacco Cessation Among Women in Brazil

Tobacco Control Network Among Women in Parana, Brazil - II

The overall goal of this renewal is three-fold: (1) to continue to sustain and strengthen the network; (2) to conduct a group randomized controlled trial to assess the efficacy of a theory-based, culturally- and gender-relevant Community Health Worker intervention for Brazilian women "light smokers" that will augment the smoking cessation programs offered through the public health system; and (3) to expand our current Career Development and Research Training Program to the other two major tobacco growing states in order to develop a cadre of well-trained researchers who will continue to develop and implement gender-relevant comprehensive tobacco control strategies at all levels.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Behavioral: 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program; Behavioral: Control

Detailed Description

An understanding of women and their tobacco-related issues, as well as the need for the development of gender-relevant tobacco control efforts, have been highlighted as priorities in landmark guiding documents published in the past few years (e.g., WHO Framework Convention on Tobacco Control-WHO FCTC). Brazil is the second largest producer of tobacco in the world, and 95% of the tobacco is produced in the three Southern states (Paraná, Santa Catarina, and Rio Grande do Sul). Although, historically, tobacco use among women in developing countries, particularly Latin America, has been relatively low as compared to men, the smoking epidemic is rapidly spreading to women in developing countries, and these three Southern states have the highest prevalence of women smokers in the country. We have established a Network for Tobacco Control among Women in Paraná, Brazil with the purpose of establishing community and institutional capacity to promote gender-relevant tobacco control efforts among women through Community-Based Participatory Research (CBPR) and training. The goals of the network are to reduce tobacco use and exposure to environmental tobacco smoke (ETS) among women in Paraná, and to develop a cadre of well-trained researchers who will continue to address comprehensive tobacco control strategies at multiple levels. The network conducted an epidemiological survey on the prevalence and factors associated with tobacco use among women across the State of Paraná. Based on the results, the network identified four priorities: (1) to implement policy changes to decrease ETS; (2) to understand the health/social issues of women in tobacco farming; (3) to develop and evaluate a comprehensive, culturally- and gender relevant, school-based smoking prevention program; and (4) to improve access and delivery of smoking cessation programs through the public health system with a particular focus on "light smokers" as 74.8% of women smokers in our study reported smoking 10 or less cigarettes/day. The network is currently addressing the first three priorities, including support for legislation, which resulted in Paraná having the strongest indoor tobacco ban in the country.

The overall goal of this renewal is three-fold: (1) to continue to sustain and strengthen the network; (2) to conduct a group randomized controlled trial to assess the efficacy of a theory-based, culturally- and gender-relevant Community Health Worker intervention for Brazilian women "light smokers" that will augment the smoking cessation programs offered through the public health system; and (3) to expand our current Career Development and Research Training Program to the other two major tobacco growing states in order to develop a cadre of well-trained researchers who will continue to develop and implement gender-relevant comprehensive tobacco control strategies at all levels.

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Woman
• Current tobacco user
• 18 years of age
• Living in the randomized neighborhood

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; The intervention arm consisted of 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program at the local Basic Health Unit.	Behavioral: 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program; 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program
Active Comparator: Control; The control arm consisted of a home visit by the Community Health Worker scheduling an appointment for the participant to attend the tobacco cessation program at the local Basic Health Unit.	Behavioral: Control; Schedule an appointment to attend tobacco cessation at Basic Health Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Cessation	Our outcome at follow-up, smoking status, was obtained from responses to the question, "Do you smoke any tobacco product?" Respondents could indicate they smoked daily, less than daily, or that they did not smoke. Those who indicated they smoked daily or less than daily were labeled as 'smokers' while those who indicated they did not smoke were labeled 'non-smokers' confirmed by exhaled carbon monoxide level	7 months follow-up

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: University of Massachusetts, Worcester; Universidade Estadual de Londrina; Pontifícia Universidade Católica do Paraná

Publications and helpful links

General Publications

• Scarinci IC, Kienen N, Wiltenburg TD, Bittencourt L, Person SD. Efficacy of a Gender-Relevant Smoking Cessation Intervention Among Women in Brazil: Findings from a Group Randomized Controlled Trial. J Womens Health (Larchmt). 2022 Nov;31(11):1620-1629. doi: 10.1089/jwh.2021.0443. Epub 2022 May 17.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2012
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: women; tobacco cessation; capacity building
• Other Study ID Numbers: IRB-120606001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: de-identified data may be shared in the future

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No