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NCT Number: NCT07734727

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

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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Key information

Conditions

Tobacco Use Behavior Disease Attributes Health Behavior Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenyatta National Hospital

Nairobi, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Percent enrollment

    Time frame: Baseline

    Percent enrollment per arm using Reach RE-AIM Framework

  2. Adoption assessed using Adoption RE-AIM Framework

    Time frame: 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.

  3. Facililtators -Implementation

    Time frame: 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.

  4. Barriers-Implementation

    Time frame: 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.

  5. Frequency of message delivery

    Time frame: up to Month 6

    Frequency of message delivery using Implementation RE-AIM Framework

  6. Frequency of message read

    Time frame: Baseline, Month 1 and Month 6

    Frequency of message read using Implementation RE-AIM Framework

  7. Frequency of response

    Time frame: up to Month 6

    Absolute and proportion of response to interactive messages using Implementation RE-AIM Framework

  8. Maintenance assessed using RE-AIM Framework

    Time frame: Month 6

    Assesses the long-term sustainability of an intervention by measuring two key levels: individual long-term effects and setting-level institutionalization.

  9. Cost

    Time frame: Month 6

    Number of texts sent x cost per text to obtain individual user cost using Implementation RE-AIM Framework

  10. Tobacco Policies Knowledge

    Time frame: Baseline and Month 1

    Change in knowledge on tobacco policies using qualitative measure based on Efficacy RE-AIM Framework

  11. Tobacco Harms Knowledge

    Time frame: 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).

  12. Tobacco Use Frequency

    Time frame: Baseline and Month 1

    Frequency of tobacco use using Efficacy RE-AIM Framework

  13. Mean Tobacco Cessation Attempts

    Time frame: Baseline and Month 1

    Mean number of tobacco cessation attempts using Efficacy RE-AIM Framework

  14. Absolute Number Tobacco Cessation Attempts

    Time frame: Baseline and Month 1

    Absolute number of tobacco cessation attempts using Efficacy RE-AIM Framework

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Ngaruiya, MD MSC DTMH

CONTACT

[email protected]

650-723-6576

Jessica Rayo, MS

CONTACT

[email protected]

559-759-4266

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: Text2Quit

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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