NCT04865276 Adaptation and Evaluation of a Tobacco Cessation Program: An Integrated mHealth Approach
| NCT ID | NCT04865276 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Tobacco Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 431 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 431 participants in total. It began in 2022-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 seeks to adapt this CHW-delivered tobacco cessation program to be integrated with mHealth support through mobile devices (App). 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 consist 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). 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. 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
Contact & Investigator
Isabel C Scarinci, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT04865276 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Tobacco Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04865276 currently recruiting?
Yes, NCT04865276 is actively recruiting participants. Contact the research team at scarinci@uab.edu for enrollment information.
Where is the NCT04865276 trial being conducted?
This trial is being conducted at Londrina, Brazil.
Who is sponsoring the NCT04865276 clinical trial?
NCT04865276 is sponsored by University of Alabama at Birmingham. The principal investigator is Isabel C Scarinci, PhD at University of Alabama at Birmingham. The trial plans to enroll 431 participants.