Formative prospective case–control study on Point-of-Care Lung Ultrasound and clinical–epidemiological factors to evaluate their association with Tuberculosis severity and predict disability (POCUS4TB-Peru)
Tuberculosis
This study will recruit adults living with TB attending health facilities (cases) and adults without TB living in the community (controls). The cases will be recruited from ongoing cohort (PREVENIR) of consecutive adult patients (≥18 years old) with TB, these will be invited to participate if they have just been diagnosed with TB, and/or have recently started treatment for TB at health facilities for no longer than 2 weeks, and who do not have any serious illness resulting in unstable or life-threatening condition. The controls will be recruited from an ongoing cohort in the community (PRESIENTE) to identify acute respiratory infections (ARI) and acute gastroenteritis. Adults will be invited to participate if ≥18 years old, if they have not received TB treatment in the last year and if they do not have any serious illness resulting in an unstable or life-threatening condition. Controls will further be divided into two groups: (a) “healthy community controls” who do not have any respiratory symptoms; and (b) “respiratory community controls” who have been identified to have an acute respiratory infection (ARI) episode. In both cases and controls, after informed consent has been provided, a questionnaire will be carried out, as well as data collection from study records, followed by physical examination (including measurements such as weight, height, blood pressure and glucose and HIV testing). Disability will be assessed using the Disability (EQ-5D-5L). Point-of-care ultrasound (POCUS) will be conducted by trained research staff and a sputum sample will be collected to assess bacteriological load and drug resistance. Follow-up will be conducted at 12 months after TB treatment initiation for cases and after recruitment for controls. A questionnaire will be performed and data will be collected from health records, to obtain information on updated survival status and TB treatment outcomes in cases. Physical examination, tests and measurements as in the baseline
Inclusion criteria for cases: 1. Current participant of the PREVENIR study 2. Aged ≥18 years old 3. Receiving or will receive treatment for TB at the selected health centre Inclusion criteria for controls: 1. Current participant in the PRESIENTE study 2. Aged ≥18 years old
Exclusion criteria for cases: 1. Started treatment >2 weeks ago for the current TB episode 2. Serious illness resulting in an unstable condition or life-threatening participation in the study Exclusion criteria for controls: 1. Received TB treatment <1 year ago. 2. Serious illness resulting in an unstable condition or life-threatening participation in the study