Mobile TB testing vans could catch hidden cases in slums
NCT ID NCT04303104
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether bringing a portable TB test (Gene Xpert) directly to people in crowded communities helps find and treat more TB cases than the usual method of waiting for people to visit a clinic. Over 3,500 adults in South Africa took part. The goal was to see if this mobile approach gets more people started on treatment quickly, especially those who are highly infectious.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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3,523 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Community participant willing to complete community-based symptom screening, finger-prick blood testing, and/or undergo TB diagnostic testing. 2. Provision of informed consent. 3. 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. 4. 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. 5. Any HIV+ve adult (older than 18 years). 6. 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 Criteria: 1. Inability to provide informed consent (e.g. mentally impaired). 2. 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. 3. Patients already diagnosed with active TB. 4. 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) 1. Adult (\> 18 years old) with significant recent exposure (within the past 6 months) to an adult with untreated or inadequately treated pulmonary TB. 2. 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. 3. 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. 4. 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 1. 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). 2. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bindiya Meggi
Maputo, Mozambique
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Helen Ayles
Lusaka, Zambia
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Junior Mutsvangwa
Harare, Zimbabwe
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University of Cape Town
Cape Town, Western Cape, 7925, South Africa
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Other studies related to the condition(s) this trial covers.
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