Tobacco CessationNCT04865276
Adaptation and Evaluation of a Tobacco Cessation Program: An Integrated mHealth Approach
A study testing Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system in people with Tobacco Cessation, run by University of Alabama at Birmingham at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Cessation
- What is being tested?
- Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age
- Current tobacco use
- Willingness to quit tobacco use
- resident in the town assigned to intervention or control
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Estadual de Londrina
Londrina, Paraná
Nadia Kienen, PhD, nadiakienen@gmail.com
About this study
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.
Read the detailed description
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 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.
- Conditions
- Tobacco Cessation
- Being tested
- Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health systemBehavioural
Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system Receives: 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 |
| Control | Active comparator | Home visit by a Community Health Worker during which the participant is scheduled to attend the tobacco cessation program at the public health system Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence (defined as no cigarettes in the past 7 days)
Nicotine abstinence as measured by self-report and CO
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 431 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Responsible party
- Principal investigator, Isabel Scarinci, University of Alabama at Birmingham
- Investigators
- Isabel C Scarinci, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865276
- Sponsor's protocol ID
- IRB-300007350
- Status last verified
- Jun 2026
- First submitted
- 25 Apr 2021
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Evaluation of a Tobacco Cessation Program: An Integrated mHealth Approach
- ClinicalTrials.gov ID
- NCT04865276
- Acronym / sponsor ID
- IRB-300007350
- Conditions
- Tobacco Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 431 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health systemIntegrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system |
| Control | Active comparator | Behavioral: Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health systemHome visit by a Community Health Worker during which the participant is scheduled to attend the tobacco cessation program at the public health system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age
- Current tobacco use
- Willingness to quit tobacco use
- resident in the town assigned to intervention or control
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health systemIntegrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system | Behavioural | Control, Intervention |
Primary outcome
7-day point prevalence abstinence (defined as no cigarettes in the past 7 days)
Time frame: 6 months
Nicotine abstinence as measured by self-report and CO
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabel C Scarinci, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system in people with Tobacco Cessation, run by University of Alabama at Birmingham at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabel C Scarinci, PhD ((205) 975-7177, scarinci@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence (defined as no cigarettes in the past 7 days) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.