Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients

NCT07734727 — Not applicable, Not yet recruiting, 285 participants, Yale University

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RegistryNCT07734727, acronym Text2Quit
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment285 (Estimated)
SponsorYale University (Other); collaborators: National Institute on Drug Abuse (NIDA)
ConditionsTobacco Use, Tobacco Use Cessation
InterventionsText2Quit-Kenya (Other)
Datesstart 2026-08-01 (estimated), primary completion 2028-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2026-07-29, last updated 2026-08-06
Locations1 site in Kenya

Related Papers Related Patents Related Grants Related Experts
All trials for Tobacco Use All trials for Tobacco Use Cessation All trials of Text2Quit-Kenya

-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. 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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Text2Quit KenyaActive comparatorOther: Text2Quit-KenyaParticipants will receive the Text2Quit intervention
ControlNo interventionStandard of care
  • Text2Quit-Kenya (Other): 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.

+Outcome measures

Primary outcomes

  • Text2Quit Survey to assess efficacy [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 [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

Secondary outcomes

  • Percent enrollment [Baseline]: Percent enrollment per arm using Reach RE-AIM Framework
  • Adoption assessed using Adoption RE-AIM Framework [up to Month 6]: 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 [up to Month 6]: Facililtators assessed using semi-structured qualitative interviews guided by the RE-AIM Implementation framework, with thematic analysis used to identify themes.
  • Barriers-Implementation [up to Month 6]: Barriers assessed using semi-structured qualitative interviews guided by the RE-AIM Implementation framework, with thematic analysis used to identify themes.
  • Frequency of message delivery [up to Month 6]: Frequency of message delivery using Implementation RE-AIM Framework
  • Frequency of message read [Baseline, Month 1 and Month 6]: Frequency of message read using Implementation RE-AIM Framework
  • Frequency of response [up to Month 6]: Absolute and proportion of response to interactive messages using Implementation RE-AIM Framework
  • Maintenance assessed using RE-AIM Framework [Month 6]: Assesses the long-term sustainability of an intervention by measuring two key levels: individual long-term effects and setting-level institutionalization.
  • Cost [Month 6]: Number of texts sent x cost per text to obtain individual user cost using Implementation RE-AIM Framework
  • Tobacco Policies Knowledge [Baseline and Month 1]: Change in knowledge on tobacco policies using qualitative measure based on Efficacy RE-AIM Framework
  • Tobacco Harms Knowledge [Baseline and Month 1]: 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).
  • Tobacco Use Frequency [Baseline and Month 1]: Frequency of tobacco use using Efficacy RE-AIM Framework
  • Mean Tobacco Cessation Attempts [Baseline and Month 1]: Mean number of tobacco cessation attempts using Efficacy RE-AIM Framework
  • Absolute Number Tobacco Cessation Attempts [Baseline and Month 1]: Absolute number of tobacco cessation attempts using Efficacy RE-AIM Framework

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

+Locations (1)

FacilityCityCountryStatus
Kenyatta National HospitalNairobiKenya

+Investigators

+Funding

NIH grants: R21DA052790