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

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ClinicalTrials.gov Identifier: NCT04865276
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : September 10, 2022
Sponsor:
Collaborator:
Universidade Estadual de Londrina
Information provided by (Responsible Party):
Isabel Scarinci, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Tobacco Cessation 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: An Integrated mHealth Approach
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : July 31, 2025

Arm Intervention/treatment
Active Comparator: 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
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

Active Comparator: 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
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




Primary Outcome Measures :
  1. 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days) [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Individuals who self-identify as women
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04865276


Contacts
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Contact: Isabel C Scarinci, PhD (205) 975-7177 scarinci@uab.edu

Locations
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Brazil
Universidade Estadual de Londrina Recruiting
Londrina, Paraná, Brazil
Contact: Nadia Kienen, PhD       nadiakienen@gmail.com   
Sponsors and Collaborators
University of Alabama at Birmingham
Universidade Estadual de Londrina
Investigators
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Principal Investigator: Isabel C Scarinci, PhD University of Alabama at Birmingham
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Responsible Party: Isabel Scarinci, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04865276    
Other Study ID Numbers: IRB-300007350
First Posted: April 29, 2021    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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