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Not yet recruiting NCT07734727

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

No phase Interventional Tobacco Use Tobacco Use Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Text2Quit-Kenya.
Who it may be relevant to
Registry conditions: Tobacco Use, Tobacco Use Cessation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Kenya
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Text2Quit-Kenya
    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 outcome measures

  • Text2Quit Survey to assess efficacy [Time frame: Baseline and 1 Month post intervention]
  • Exhaled Carbon Monoxide testing to assess efficacy [Time frame: Baseline, Month 1 and Month 6]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Kenya · 1 center
  • Kenyatta National Hospital — Nairobi

Identifiers

NCT: NCT07734727 · 2000031446 · R21DA052790

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗