Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Near-point-of-care NAAT testing on Huwel UniAMP using tongue swabs and sputum swabs: This study will evaluate the UniAMP Point-of-Care NAAT device, developed by Huwel Lifesciences, whic
Sponsors
Stop TB Partnership hosted by UNOPS (United Nations Office for Project Services) TB
Eligibility
Inclusion criteria
Inclusion criteria: Main study : Testing of Presumptive TB in Healthcare Facilities Outpatients aged 18 years or above with any TB symptom (fever for 2 weeks or more, cough for 2 weeks or more, hemoptysis, weight loss, night sweats), willing to provide atleast one of tongue swab or sputum samples Sub-study 1: Household contacts investigation Adult household contacts of persons with TB initiated on treatment for TB in the study facilities during the study period, or in the three prior months prior to the start of the study Sub-study 2: Active case finding Adults screened in the community for TB by NTEP mobile XRay units, with symptoms of TB (fever for 2 weeks or more, cough for 2 weeks or more, hemoptysis, weight loss, night sweats) or risk factors (HIV, undernutrition, diabetes, smoking, alcohol use, past history of TB)
Exclusion criteria
Exclusion criteria: Participants with a current diagnosis of TB who are already receiving Anti Tubercular Therapy will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NAAT Tested: Proportion of chest symptomatics tested by NAAT (swab-based NPoC NAAT and/or routine sputum CBNAAT or Truenat)Timepoint: within one week of participant identification | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity of swab-based NPoC NAAT for diagnosis of pulmonary TB with reference to sputum CBNAAT/Truenat and/or clinical decision to treatTimepoint: Within one month of participant identification;Participant/provider perceptions of acceptability of testTimepoint: Participant - Within one week of participant identification Provider - Interrim/end-line | — |
Countries
India
Contacts
Public ContactDr Shruthee SG
Resource Group for Education and Advocacy for Community Health (REACH)
Outcome results
None listed