Clinical trial NCT04865276: Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: an Integrated MHealth Approach
Official title: Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil: an Integrated MHealth Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Cessation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Universidade Estadual de Londrina
First posted: 2021-04-29
Enrollment: 431
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Universidade Estadual de Londrina
state: Paraná
Study officials:
affiliation: University of Alabama at Birmingham
name: Isabel C Scarinci, PhD
role: PRINCIPAL_INVESTIGATOR
References: