Adaptation and Evaluation of a Tobacco Cessation Program: An Integrated mHealth Approach

Condition(s) studied

Investigational drug(s) / intervention(s)

Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system: 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 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

Primary outcome measure(s)

• 7-day point prevalence abstinence (defined as no cigarettes in the past 7 days) — 6 months
  Nicotine abstinence as measured by self-report and CO

Trial sites (1)

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