NCT05220163Active, not recruiting
Evaluating the Impact of Computer-assisted X-ray Diagnosis and Other Triage Tools to Optimise Xpert Orientated Community-based Active Case Finding for TB and COVID-19
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
Tuberculosis (TB) is now the commonest cause of death in many African countries. Globally, \~35% (almost 1 in 3) of TB cases are 'missed' (remain undiagnosed or undetected). In sub-Saharan Africa, 40-50% of the TB case burden remains undiagnosed within the community. These 'missed' TB cases (at primary care level) serve as a reservoir, which severely undermines TB control. With rapid advances in the development of TB screening tests, the investigators aim to determine the pragmatic utility of computer-assisted x-ray diagnosis (CAD). Recent data suggest that CAD performs on par with experienced radiologists to identify potential TB cases, hereby reducing the frequency at which Xpert tests are requested and helps to focus limited resources on the relevant cases. In addition, the investigators aim to test nascent screening technologies for TB diagnosis such as evaluating urine-based TB screening biosignatures. The COVID-19 pandemic has ravaged African peri-urban communities where TB is also common. With the pressing need to improve screening and diagnosis of COVID-19, the investigators plan to explore the potential for urine- and blood-based COVID-19 screening assays. Symptoms of COVID-19 and TB overlap, and limited affordability, as well as the stigma associated with both diseases, severely limits testing. Data are now urgently needed about the feasibility of co-screening and testing for TB and COVID-19. The utility of such an approach, if any, has not been studied in African communities.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 26200 (estimated)
- First submitted
- 1 Feb 2022
- Start date
- 23 Feb 2022
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- University of Cape Town
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT05220163
What you commit to
- Study type: Interventional
- Planned participants: 26200
- From 23 Feb 2022 to the primary completion date, 30 Jun 2026
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Inability to provide informed consent (e.g., mentally impaired).
- Participants who have completed TB treatment in the last two months, or who have self-presented to their local TB clinic and are currently being worked up for suspected TB.
- Participants already diagnosed with active TB on treatment.
- Participants unable to commit to at least a two-month follow-up.
- Female participants who are pregnant or who refuse a urine pregnancy test.
- Participants in the community who cannot access healthcare due to severe ill health or lack of access to the local clinic.
Who the study is looking for
- Participants willing to complete community-based symptom screening, finger-prick and venepuncture blood sampling, urine testing, and/or undergo TB and/or COVID-19 diagnostic testing.
- Provision of informed consent.
- Participant 18 years or above.
- HIV-positive or negative participants will be included.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cape Town Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Helen Ayles Coordinator of this site? Confirm its status | Lusaka | Zambia | Unknown status |
| Junior Mutsvangwa Coordinator of this site? Confirm its status | Harare | Zimbabwe | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.