NCT07734727

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jun 2026Jun 2028

First Submitted

Initial submission to the registry

May 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

May 21, 2026

Last Update Submit

July 23, 2026

Conditions

Tobacco UseTobacco Use Cessation

Keywords

KenyaAfricaNoncommunicable diseaseglobal health

Outcome Measures

Primary Outcomes (2)

  • Text2Quit Survey to assess efficacy

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

    Baseline and 1 Month post intervention

  • 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

    Baseline, Month 1 and Month 6

Secondary Outcomes (14)

  • Percent enrollment

    Baseline

  • Adoption assessed using Adoption RE-AIM Framework

    up to Month 6

  • Facililtators -Implementation

    up to Month 6

  • Barriers-Implementation

    up to Month 6

  • Frequency of message delivery

    up to Month 6

  • +9 more secondary outcomes

Study Arms (2)

Text2Quit Kenya

ACTIVE COMPARATOR

Participants will receive the Text2Quit intervention

Other: Text2Quit-Kenya

Control

NO INTERVENTION

Standard of care

Interventions

Text2Quit-KenyaOTHER

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.

Text2Quit Kenya

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenyatta National Hospital

Nairobi, Kenya

Location

MeSH Terms

Conditions

Tobacco UseTobacco Use CessationNoncommunicable Diseases

Condition Hierarchy (Ancestors)

BehaviorHealth BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christine Ngaruiya, MD MSC DTMH

    Stanford School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Ngaruiya, MD MSC DTMH

CONTACT

650-723-6576cngaruiya@stanford.edu

Jessica Rayo, MS

CONTACT

559-759-4266jrayo@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

July 29, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)