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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

NCT05220163

Active Not RecruitingNA

Sponsor: University of Cape Town

Conditions: Tuberculosis, COVID-19, HIV Infections

Interventions: CAD, Xpert

Countries: South Africa, Zambia, Zimbabwe

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (3)

Cape Town, Western Cape, South Africa
Lusaka, Zambia
Harare, Zimbabwe