Gender-Relevant Tobacco Cessation Among Women in Brazil

• ClinicalTrials.gov Identifier: NCT03845413
• Recruitment Status: Completed
• First Posted: February 19, 2019
• Last Update Posted: November 5, 2019
• Sponsor: University of Alabama at Birmingham
• Collaborators: Pontifícia Universidade Católica do Paraná; Universidade Estadual de Londrina; University of Massachusetts, Worcester
• Information provided by (Responsible Party): Isabel Scarinci, University of Alabama at Birmingham

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Tobacco Use Cessation	Behavioral: Control; Behavioral: 12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 338 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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. The intervention arm consisted of 12-home visits by the Community Health Worker
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Tobacco Control Network Among Women in Parana, Brazil - II
• Actual Study Start Date: June 20, 2012
• Actual Primary Completion Date: July 30, 2018
• Actual Study Completion Date: July 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Tobacco Cessation [ Time Frame: 7 months follow-up ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: This trial was gender-relevant to include women only
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Isabel Scarinci, Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03845413
• Other Study ID Numbers: IRB-120606001
• First Posted: February 19, 2019
• Last Update Posted: November 5, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: de-identified data may be shared in the future

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Isabel Scarinci, University of Alabama at Birmingham:

tobacco cessation; women; capacity building