Usability mTBScreen

NCT07840989 | Completed

• 1 other identifier: 5441-2024 mTBscreen
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

Building on recent developments in the sphere of digital health and data science, as well as the principles of usability engineering, we propose to assess the usability of a digital tool called mTBscreen for tuberculosis (TB) screening and triage. The investigators will evaluate the ease-of-use, usability and preliminary acceptability of the tool when used by healthcare workers. This will inform the design and implementation of its use in an effectiveness-implementation study in lower health care levels for the identification of individuals at high risk of TB

Conditions

Tuberculosis (TB)

Keywords

Tuberculosis; mTBscreen; Digital tool; Usability

Outcome Measures

Primary Outcomes (1)

• Identify critical aspects to achieve adoption and sustained use of these tools in the intended setting

  Critical factors influencing the adoption and sustained use of the tools in the intended setting will be assessed using structured observations and in-depth interviews (IDIs). Data will be analysed thematically to identify key barriers, facilitators, usability considerations, workflow challenges, acceptability, and other factors affecting adoption and sustained use of the tools

  12 months after implementation begins

Secondary Outcomes (1)

• Explore the relative advantage of the tools and their potential integration into the workflow at health facilities in Zambia.

  12 months after implementation begins

Study Arms (1)

Health Care Workers

Healthcare workers aged 18 years or older who are involved in the care of individuals with presumptive tuberculosis (TB) and provide informed consent to participate. Participants include clinical officers, nurses, physicians, and community or lay healthcare workers recruited from five health facilities in Lusaka, Zambia. Participants use the mTBScreen v1.0 digital TB screening application to complete standardized usability tasks, followed by a think-aloud exercise, the System Usability Scale (SUS) questionnaire, and a semi-structured interview. The intervention of interest is the use of the mTBScreen application to assess its usability, acceptability, workflow integration, and user experience among intended end users.Hea

Other: mTBscreen Application; Device: Mobile phone Application

Interventions

mTBscreen Application OTHER

The mTBscreening tool, a digital application designed to support tuberculosis (TB) screening and triage, will be assessed for its usability in line with recent advancements in digital health, data science, and usability engineering principles. This study will evaluate the tool's ease of use, overall usability, and preliminary acceptability among healthcare workers. Findings from this assessment will inform the design and implementation of a subsequent effectiveness-implementation study aimed at identifying individuals at high risk of TB in lower levels of the healthcare system

Health Care Workers

Mobile phone Application DEVICE

The mTBscreen app is a smartphone-based tuberculosis (TB) screening application that uses a machine learning (ML) algorithm to estimate an individual's risk of having active TB based on clinical, demographic, and epidemiological information

Also known as: mTB screen App

Health Care Workers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be healthcare workers (\>18 years old) who provide care for persons with TB. This will include clinical officers, nurses, or physicians, and also lay/volunteer healthcare workers. In general, we seek to include persons similar to the intended end users of the mTBscreen tool. Participants will be recruited from five healthcare facilities, namely Kanyama General Hospital, Chawama General Hospital, Chilenje General Hospital, Chipata Level 1 Hospital, and Matero Level 1 Hospital.

You may qualify if:

• Aged 18 years or older
• Healthcare worker involved in the care of persons with presumptive TB
• Providing informed consent

You may not qualify if:

• Do not agree with recording of the interview

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead

Study Sites (4)

Chawama level one Hospital

Lusaka, 10101, Zambia

Location

Chilenje level one Hospital

Lusaka, 10101, Zambia

Location

Kanyama level one Hospital

Lusaka, 10101, Zambia

Location

Matero level one Hospital

Lusaka, 10101, Zambia

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: September 25, 2026
• Study Start: September 20, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (4)