Tuberculosis
Conditions
Interventions
MiniDock MTB
Xpert MTB RIF Ultra
Sponsors
Centre for Health Solutions Kenya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible for enrolment if they meet all the following: 1. Presenting with symptoms and/or radiologic findings suggestive of TB, as per Kenya NTLD-P guidelines (e.g., cough, weight loss, fever, night sweats, abnormal CXR), and referred by the clinician for TB diagnostic testing. 2. Adults and children (12-17 years). 3. Attending one of the participating study facilities (or linked outreach) and planning to remain in the facility catchment area for at least 2–3 months to allow complete follow-up for treatment initiation. 4. Able and willing to provide at least one tongue swab specimen (self-collected with guidance or collected by an HCW for minors who are unable to do so on their own). Where sputum is required for reference testing, able to provide sputum or sputum swab (unless exempted by protocol for certain sub-groups). 5. Able to understand the study information (with translator support as needed) and provide written informed consent (and assent where applicable). For HCW / key informant participants (implementation & acceptability) 6. Currently working at a participating facility (clinical, laboratory, pharmacy, data/records, or management staff). 7. Involved in TB screening, diagnostics, or treatment, or in oversight/coordination of these services. 8. Willing and able to provide informed consent for interviews, FGDs, or surveys.
Exclusion criteria
Exclusion criteria: For patient participants Patients will be excluded if any of the following apply: 1. Decline to participate or are unable to provide informed consent (and assent/guardian consent where required). 2. Present for unrelated services without undergoing TB screening or diagnostic evaluation (i.e., not presumptive TB in this visit). 3. Already enrolled in this study for the same episode of illness (to avoid double counting). 4. Critically ill patients requiring urgent referral or inpatient stabilization where study procedures (e.g., additional swabs, questionnaires) would interfere with clinical care. These patients may still receive routine TB diagnostics as per standard care. 5. Any condition judged by the clinician to significantly increase the risk from tongue/sputum sampling (e.g., severe oral lesions or bleeding disorders), if the investigator believes participation is not in the patient’s best interest. For HCW / key informant participants 1. Not directly involved in TB services or device use/oversight (for HCW-specific tools). 2. Decline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of bacteriologically confirmed TB patients initiating treatment within 24 hrs of first clinical contact | — |
Secondary
| Measure | Time frame |
|---|---|
| Operational feasibility of implementing MiniDock MTB in low-resource settings;Cost per case detected and treated ;Cost per additional same-day diagnosis and treatment initiation;Acceptability/usability of MiniDock MTB | — |
Countries
Kenya
Contacts
Public ContactNkirote Mugambi Nyaboga
Centre for Health Solutions Kenya
Outcome results
None listed