Tobacco UseText2QuitNCT07734727
Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
A study testing Text2Quit-Kenya in people with Tobacco Use and Tobacco Use Cessation, run by Yale University at 1 site in Kenya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use, Tobacco Use Cessation
- What is being tested?
- Text2Quit-Kenya
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteKenya
- Study dates
- Nov 2026to Jun 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Able and willing to provide informed consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Tobacco Use, Tobacco Use Cessation
- Being tested
- Text2Quit-Kenya
- Keywords
- Kenya, Africa, Noncommunicable disease, global health
- Medical subject headings
- Tobacco Use, Tobacco Use Cessation, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text2Quit-KenyaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Text2Quit Kenya | Active comparator | Participants will receive the Text2Quit intervention Receives: Other: Text2Quit-Kenya |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Text2Quit Survey to assess efficacy
Efficacy will be assessed by self-report binary quantitative outcome of tobacco use in past 7 days
Measured: 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
Measured: Baseline, Month 1 and Month 6
Secondary outcomes (14)
Percent enrollment
Percent enrollment per arm using Reach RE-AIM Framework
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to Month 6
Frequency of message delivery
Frequency of message delivery using Implementation RE-AIM Framework
Measured: up to Month 6
Frequency of message read
Frequency of message read using Implementation RE-AIM Framework
Measured: Baseline, Month 1 and Month 6
Frequency of response
Absolute and proportion of response to interactive messages using Implementation RE-AIM Framework
Measured: 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.
Measured: Month 6
Cost
Number of texts sent x cost per text to obtain individual user cost using Implementation RE-AIM Framework
Measured: Month 6
Tobacco Policies Knowledge
Change in knowledge on tobacco policies using qualitative measure based on Efficacy RE-AIM Framework
Measured: 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).
Measured: Baseline and Month 1
Tobacco Use Frequency
Frequency of tobacco use using Efficacy RE-AIM Framework
Measured: Baseline and Month 1
Mean Tobacco Cessation Attempts
Mean number of tobacco cessation attempts using Efficacy RE-AIM Framework
Measured: Baseline and Month 1
Absolute Number Tobacco Cessation Attempts
Absolute number of tobacco cessation attempts using Efficacy RE-AIM Framework
Measured: Baseline and Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Christine Ngaruiya, MD MSC DTMH, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734727
- Sponsor's protocol ID
- 2000031446
- Other IDs
- R21DA052790
- Acronym
- Text2Quit
- Status last verified
- Oct 2026
- First submitted
- 21 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
- ClinicalTrials.gov ID
- NCT07734727
- Acronym / sponsor ID
- Text2Quit / 2000031446
- Conditions
- Tobacco Use, Tobacco Use Cessation
- Keywords
- Kenya, Africa, Noncommunicable disease, global health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Jul 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text2Quit Kenya | Active comparator | Other: Text2Quit-KenyaParticipants will receive the Text2Quit intervention |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Able and willing to provide informed consent.
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Text2Quit-KenyaA 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. | Other | Text2Quit Kenya |
Primary outcome
Text2Quit Survey to assess efficacy
Time frame: Baseline and 1 Month post intervention
Efficacy will be assessed by self-report binary quantitative outcome of tobacco use in past 7 days
Exhaled Carbon Monoxide testing to assess efficacy
Time frame: Baseline, Month 1 and Month 6
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
14 secondary outcomes
Percent enrollment
Time frame: Baseline
Adoption assessed using Adoption RE-AIM Framework
Time frame: up to Month 6
Facililtators -Implementation
Time frame: up to Month 6
Barriers-Implementation
Time frame: up to Month 6
Frequency of message delivery
Time frame: up to Month 6
Frequency of message read
Time frame: Baseline, Month 1 and Month 6
Frequency of response
Time frame: up to Month 6
Maintenance assessed using RE-AIM Framework
Time frame: Month 6
Cost
Time frame: Month 6
Tobacco Policies Knowledge
Time frame: Baseline and Month 1
Tobacco Harms Knowledge
Time frame: Baseline and Month 1
Tobacco Use Frequency
Time frame: Baseline and Month 1
Mean Tobacco Cessation Attempts
Time frame: Baseline and Month 1
Absolute Number Tobacco Cessation Attempts
Time frame: Baseline and Month 1
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 27 Oct 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.
Christine Ngaruiya, MD MSC DTMH principal investigator
Stanford School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text2Quit-Kenya in people with Tobacco Use and Tobacco Use Cessation, run by Yale University at 1 site in Kenya.
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 5 inclusion and 4 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 27 Oct 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 Kenya. 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 Christine Ngaruiya, MD MSC DTMH (650-723-6576, cngaruiya@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Text2Quit Survey to assess efficacy (time frame: Baseline and 1 Month post intervention). The study lists 2 primary outcomes in all. 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 27 Oct 2026.