About this trial
In this study, investigators will adapt and implement Text2Quit in a Kenyan ED population will increase knowledge and cessation. Investigators will use a mixed-methods, hybrid implementation-effectiveness approach to assess these outcomes. Results will inform a randomized, controlled trial in a nationally representative sample of EDs in future. This study will be the first to target tobacco use in this population, the first to use mobile cessation, and will contribute to advancing implementation science on tobacco cessation globally. It will also provide a novel approach to implementation for mHealth interventions, with findings that can be generalized to other Non-Communicable Diseases and risk factors, such as alcohol use, hypertension and diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Current tobacco users (self-identified smokers).
Presenting to the Emergency Department (ED) at Kenyatta National Hospital (KNH).
Own a mobile phone capable of receiving text messages.
Willing to quit tobacco use.
Disqualifiers
Individuals unwilling or unable to provide consent.
Non-tobacco users.
Those without access to a mobile phone.
Patients who are critically ill or otherwise unable to participate (practically excluded at triage).
Trial design
Parallel
Treatments tested in this trial
Text2Quit-Kenya
Other interventionA text message-based mHealth tool addressing tobacco cessation. The program is organized around automated, bidirectional text messages timed for a user's quit date. Messages based on social cognitive theory prompt users to track smoking, report on cravings and on smoking status.
Treatment groups
Trial outcomes
Primary outcomes
Text2Quit Survey to assess efficacy
Efficacy will be assessed by self-report binary quantitative outcome of tobacco use in past 7 days
Exhaled Carbon Monoxide testing to assess efficacy
Efficacy will be assessed by repeat exhaled Carbon Monoxide testing. Will be assessed using both a binary assessment with a cutoff of 10% and a continuous assessment of percent point prevalence
Secondary outcomes
Percent enrollment
Percent enrollment per arm using Reach RE-AIM Framework
Adoption assessed using Adoption RE-AIM Framework
This is a qualitative outcome. The measure will be assessed using a semi-structured interview guide informed by the RE-AIM Adoption framework. Interview transcripts will undergo thematic analysis to identify themes related to intervention adoption, future use, and perceived fit within the target community.
Facililtators -Implementation
Facililtators assessed using semi-structured qualitative interviews guided by the RE-AIM Implementation framework, with thematic analysis used to identify themes.
Barriers-Implementation
Barriers assessed using semi-structured qualitative interviews guided by the RE-AIM Implementation framework, with thematic analysis used to identify themes.
Sponsors and contacts
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Yale University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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