Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865276
Status:
RECRUITING
Last Update Posted:
2023-09-18
First Post:
2021-04-25
Brief Title:
Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil an Integrated MHealth Approach
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Adaptation and Evaluation of a Culturally and Gender Relevant Tobacco Cessation Among Women in Brazil an Integrated MHealth Approach
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N344 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 US
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None