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Completed

NCT Number: NCT07840989

Usability mTBScreen

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chawama level one Hospital, Lusaka, Zambia

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About this study

The use of innovative screening tools has the potential to significantly enhance early detection and treatment initiation, ultimately contributing to the reduction of TB (tuberculosis) incidence and mortality. However, the success of these tools relies not only on their technical capabilities (e.g., accuracy) but also on their usability and integration into healthcare workers' routines. Assessing the usability and human factors of health tools is thus paramount to ensure their effective adoption and sustained use in clinical settings. Usability refers to the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use (21). In the context of health tools, usability assessment encompasses evaluating the interface design, workflow integration, cognitive load, and overall user experience. Human factors, on the other hand, consider the interactions between humans and the system, focusing on designing systems that accommodate the user's physical and cognitive abilities, thereby minimizing errors and enhancing performance.

Tools and technologies with high usability lead to improved job performance among healthcare workers, reducing the likelihood of errors. Moreover, usability evaluation can provide insights into the tool's adaptability to different healthcare settings, the learning curve for new users, and the tool's efficacy in real-world clinical scenarios. Tools that are difficult to use or integrate into existing workflows may never be adopted or be underutilized or misused, leading to missed opportunities for early TB detection and treatment.

Building on recent developments in digital health and data science, as well as the principles of usability engineering, in this study we propose to assess the usability of mTBscreen, a digital tool for 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Do not agree with recording of the interview

Treatment and study plan

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

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

Other names: mTB screen App

Primary outcomes

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

    Time frame: 12 months after implementation begins

    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

Secondary outcomes

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

    Time frame: 12 months after implementation begins

    Structured observations and in-depth interviews (IDIs) will be used to assess the perceived relative advantage of the tools compared with existing practices and their potential integration into routine health-facility workflows in Zambia. Data will be analysed thematically to identify themes and sub-themes related to perceived benefits and disadvantages, usability, compatibility with existing workflows, effects on staff roles and workload, operational requirements, and barriers and facilitators to workflow integration

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre for Infectious Disease Research in Zambia

Other

Registry information

Official study title

Usability of mTBScreen, a Digital Solution for Tuberculosis Screening, in Zambia

Acronym: mTBscreen

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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