Status:
ACTIVE_NOT_RECRUITING
Xpert Active Case-finding Trial 3 (XACT-3)
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Zambart (University of Zambia), Zambia
Instituto Nacional de Saúde, Mozambique
Conditions:
Tuberculosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
TB remains the foremost infectious disease killer globally. A startling statistic is that two out of every five TB cases globally (40%) remain undiagnosed and untreated. These 'missed' or undiagnosed ...
Detailed Description
In the proposed study (XACT III) the investigators will use the same approach (as for XACT II), but it remains to be shown that such a strategy is scalable and feasible in different settings where the...
Eligibility Criteria
Inclusion
- Community participant willing to complete community-based symptom screening, finger-prick blood testing, and/or undergo TB diagnostic testing.
- Provision of informed consent.
- Has documentation of, or willingness to be tested for HIV infection. HIV testing does not need to be repeated if there is written documentation of a confirmed positive test at any time in the past.
- HIV-negative adults (older than 18 years) with 1 or more of the following:• cough ≥ 2 weeks• loss of weight• Fever• night sweats• generalized fatigue• haemoptysis• chest pain.
- Any HIV+ve adult (older than 18 years).
- Agrees to the collection and storage of blood, urine, sputum specimens for use for future research. (The participant may decline collection of specimens for human genetic research and still be eligible for the study).
Exclusion
- Inability to provide informed consent (e.g. mentally impaired).
- Patients who have completed TB treatment in the last 2 months, or who have self-presented to their local TB clinic and are currently being worked up for suspected TB.
- Patients already diagnosed with active TB.
- Patients unable to commit to a two month follow up or who do not wish to be followed up.
- Inclusion criteria for Household contacts (HHC)
- Adult (\> 18 years old) with significant recent exposure (within the past 6 months) to an adult with untreated or inadequately treated pulmonary TB.
- No clinical signs or symptoms of active TB that include, but are not limited to: persistent cough, haemoptysis, fever, unintended weight loss or failure to thrive (children), fatigue or lethargy, night sweats, pleuritic chest pain, draining lymph node, or other evidence of extra-pulmonaryTB. If clinical signs or symptoms of TB are present, Chest X-Ray and/or sputum culture results must be included in the overall evaluation to rule out active TB.
- Has signed a written consent or witnessed oral consent in the case of illiteracy, prior to his/her first sample or other study-specific data being collected.
- Agrees to the collection and storage of blood, urine, saliva and sputum specimens for use for future research. (The participant may decline collection of specimens for human genetic research and still be eligible for the study.)
- Exclusion Criteria for Household contacts
- Plans to move from his/her current residence, which would interfere with the participant's ability to complete all study visits (through the Month 24Visit).
- Has an active psychiatric condition, or alcohol or drug dependence that, in the opinion of the site investigator or designee, might interfere with the ability to give true informed consent and to adhere to the study requirements.
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
3394 Patients enrolled
Trial Details
Trial ID
NCT04303104
Start Date
March 26 2021
End Date
December 30 2025
Last Update
July 16 2024
Active Locations (4)
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1
Bindiya Meggi
Maputo, Mozambique
2
University of Cape Town
Cape Town, Western Cape, South Africa, 7925
3
Helen Ayles
Lusaka, Zambia
4
Junior Mutsvangwa
Harare, Zimbabwe