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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Text2Quit-Kenya

    Other intervention

    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.

Treatment groups

285 Participants
are divided into 2 treatment groups
Group A: Text2Quit KenyaActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Text2Quit Survey to assess efficacy

Efficacy will be assessed by self-report binary quantitative outcome of tobacco use in past 7 days

Time frame
Baseline and 1 Month post intervention
2

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

Time frame
Baseline, Month 1 and Month 6

Secondary outcomes

1

Percent enrollment

Percent enrollment per arm using Reach RE-AIM Framework

Time frame
Baseline
2

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.

Time frame
up to Month 6
3

Facililtators -Implementation

Facililtators assessed using semi-structured qualitative interviews guided by the RE-AIM Implementation framework, with thematic analysis used to identify themes.

Time frame
up to Month 6
4

Barriers-Implementation

Barriers assessed using semi-structured qualitative interviews guided by the RE-AIM Implementation framework, with thematic analysis used to identify themes.

Time frame
up to Month 6

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: