Tobacco Use, Tobacco Use Cessation
Conditions
Keywords
Kenya, Africa, Noncommunicable disease, global health
Brief 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.
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
OTHERText2Quit-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.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Kenya
Contacts
CONTACTChristine Ngaruiya, MD MSC DTMH
CONTACTJessica Rayo, MS
PRINCIPAL_INVESTIGATORChristine Ngaruiya, MD MSC DTMH
Stanford School of Medicine
Outcome results
None listed