Tuberculosis (TB)mTBscreenNCT07840989
Usability mTBScreen
An observational study of Tuberculosis (TB), run by Centre for Infectious Disease Research in Zambia at 4 sites in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis (TB)
- What is being tested?
- mTBscreen Application and Mobile phone Application
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 4 sitesZambia
- Study dates
- 20 Sep 2024to 27 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged 18 years or older
- Healthcare worker involved in the care of persons with presumptive TB
- Providing informed consent
Who cannot join
- Do not agree with recording of the interview
Trial locations and contacts
4 sites in 1 country.
Zambia4 sites
Chawama level one Hospital
Lusaka, 10101
Chilenje level one Hospital
Lusaka, 10101
Kanyama level one Hospital
Lusaka, 10101
Matero level one Hospital
Lusaka, 10101
About this study
Official title: Usability of mTBScreen, a Digital Solution for Tuberculosis Screening, in Zambia
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
Read the detailed description
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.
- Conditions
- Tuberculosis (TB)
- Being tested
- mTBscreen Application, Mobile phone Application
- Keywords
- Tuberculosis, mTBscreen, Digital tool, Usability
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mTBscreen ApplicationOther
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 ApplicationDevice
Also called mTB screen App
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: mTBscreen Application; Device: Mobile phone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: 12 months after implementation begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Sep 2024
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840989
- Sponsor's protocol ID
- 5441-2024 mTBscreen
- Acronym
- mTBscreen
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of mTBScreen, a Digital Solution for Tuberculosis Screening, in Zambia
- ClinicalTrials.gov ID
- NCT07840989
- Acronym / sponsor ID
- mTBscreen / 5441-2024 mTBscreen
- Conditions
- Tuberculosis (TB)
- Keywords
- Tuberculosis, mTBscreen, Digital tool, Usability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Care Workers | – | Other: mTBscreen Application, Device: Mobile phone ApplicationHealthcare 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Healthcare worker involved in the care of persons with presumptive TB
- Providing informed consent
Key exclusion criteria (1 listed)
- Do not agree with recording of the interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mTBscreen ApplicationThe 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 | Other | Health Care Workers |
| Mobile phone ApplicationAlso: mTB screen AppThe 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 | Device | Health Care Workers |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis (TB), run by Centre for Infectious Disease Research in Zambia at 4 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify critical aspects to achieve adoption and sustained use of these tools in the intended setting (time frame: 12 months after implementation begins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.