Actively Recruiting
Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: An Integrated mHealth Approach
Led by University of Alabama at Birmingham · Updated on 2025-07-09
431
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
U
Universidade Estadual de Londrina
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a culturally and gender-relevant tobacco cessation program designed for low-income Brazilian women. This program builds on prior successful Community Health Worker (CHW) interventions and integrates mobile health (mHealth) support through an interactive app. The goal is to evaluate if this combined CHW and mHealth approach can improve quitting rates compared to the existing tobacco cessation program offered by the public health system. The study has two phases. In phase I, the tobacco cessation program will be adapted and tested for feasibility with input from participants and stakeholders. Phase II involves a group randomized trial with eight towns and 344 women participants. One group receives the integrated CHW-mHealth intervention plus the standard public health tobacco cessation program, while the comparison group receives a home visit from a CHW who schedules attendance at the tobacco cessation program. Participants will be followed for at least six months, during which researchers will measure tobacco abstinence defined as no cigarette use in the past seven days. Abstinence will be verified by self-report and confirmed with exhaled carbon monoxide tests in about 30% of participants. The study will assess the effectiveness of the integrated program and may offer a model for tobacco cessation interventions in low-resource areas. The total participation time includes the initial adaptation phase and the randomized trial period.
CONDITIONS
Brief Title
Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: An Integrated mHealth Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age
- Current tobacco use
- Willingness to quit tobacco use
- Resident in the town assigned to intervention or control
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive an integrated tobacco cessation intervention delivered by Community Health Workers with support from an app and attend a tobacco cessation program at the public health system, or receive a home visit by a Community Health Worker and are scheduled to attend the tobacco cessation program.
Visits occur as part of the tobacco cessation program and home visits as scheduled
Trial Site Locations
Total: 1 location
1
Universidade Estadual de Londrina
Londrina, Paraná, Brazil
Actively Recruiting
Research Team
I
Isabel C Scarinci, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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