An interventional study of Text2Quit-Kenya in Tobacco Use and Tobacco Use Cessation, sponsored by Yale University. Recruiting at 1 site in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
Aim 1. To assess tobacco use and willingness to engage with mHealth for tobacco cessation targeting Kenyan ED patients.
Aim 2. To adapt the Text2Quit mHealth tool for use in the Kenya context using a participatory approach.
Aim 3. To pilot test Text2Quit-Kenya and assess its acceptability, feasibility, and efficacy.
The focus of this registration is Aim 3.
420 studies on the registry are indexed under Tobacco Use; 82 are open to participants now.
This study's planned enrollment of 285 is above the median of 124 across 351 interventional studies indexed under Tobacco Use.
Browse Tobacco Use studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the Text2Quit intervention
Other: Text2Quit-Kenya
Standard of care
A 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.
Text2Quit Survey to assess efficacy
Efficacy will be assessed by self-report binary quantitative outcome of tobacco use in past 7 days
Time frame: Baseline and 1 Month post intervention
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
Time frame: Baseline, Month 1 and Month 6
Percent enrollment
Percent enrollment per arm using Reach RE-AIM Framework
Time frame: Baseline
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.
Time frame: up to Month 6
Facililtators -Implementation
Facililtators assessed using semi-structured qualitative interviews guided by the RE-AIM Implementation framework, with thematic analysis used to identify themes.
Time frame: up to Month 6
Barriers-Implementation
Barriers assessed using semi-structured qualitative interviews guided by the RE-AIM Implementation framework, with thematic analysis used to identify themes.
Time frame: up to Month 6
Frequency of message delivery
Frequency of message delivery using Implementation RE-AIM Framework
Time frame: up to Month 6
Frequency of message read
Frequency of message read using Implementation RE-AIM Framework
Time frame: Baseline, Month 1 and Month 6
Frequency of response
Absolute and proportion of response to interactive messages using Implementation RE-AIM Framework
Time frame: up to Month 6
Maintenance assessed using RE-AIM Framework
Assesses the long-term sustainability of an intervention by measuring two key levels: individual long-term effects and setting-level institutionalization.
Time frame: Month 6
Cost
Number of texts sent x cost per text to obtain individual user cost using Implementation RE-AIM Framework
Time frame: Month 6
Tobacco Policies Knowledge
Change in knowledge on tobacco policies using qualitative measure based on Efficacy RE-AIM Framework
Time frame: Baseline and Month 1
Tobacco Harms Knowledge
Change in knowledge on tobacco harms of use using qualitative measure based on Efficacy RE-AIM Framework. Mean count of correct responses to the tobacco harms knowledge items, with scores ranging from 0 to 5 (higher scores indicate greater knowledge).
Time frame: Baseline and Month 1
Tobacco Use Frequency
Frequency of tobacco use using Efficacy RE-AIM Framework
Time frame: Baseline and Month 1
Mean Tobacco Cessation Attempts
Mean number of tobacco cessation attempts using Efficacy RE-AIM Framework
Time frame: Baseline and Month 1
Absolute Number Tobacco Cessation Attempts
Absolute number of tobacco cessation attempts using Efficacy RE-AIM Framework
Time frame: Baseline and Month 1
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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