Early risk assessment in paediatric and adult household contacts of confirmed tuberculosis cases by novel diagnostic tests (ERASE-TB): protocol for a prospective, non-interventional, longitudinal, multicountry cohort study. Issue 7 (19th July 2022)

• Record Type: Journal Article
• Authors: Marambire, Edson Tawanda; Banze, Denise; Mfinanga, Alfred; Mutsvangwa, Junior; Mbunda, Theodora D; Ntinginya, Nyanda Elias; Celso, Khosa; Kallenius, Gunilla; Calderwood, Claire J; Geldmacher, Christof; Held, Kathrin; Appalarowthu, Tejaswi; Rieß, Friedrich; Panzner, Ursula; Heinrich, Norbert; Kranzer, Katharina
• Other Names: author non-byline.; Shepherd Anna author non-byline.; Dockrell Hazel M author non-byline.; Bruchfeld Judith author non-byline.; Sundling Christopher author non-byline.; Sandy Charles author non-byline.; Mugava Mishelle author non-byline.; Bandason Tsitsi author non-byline.; Chipinduro Martha author non-byline.; Mutasa Kuda author non-byline.; Rukobo Sandra author non-byline.; Sudi Lwitiho author non-byline.; Haule Antelmo author non-byline.; Sichone Emmanuel author non-byline.; Qwaray Paschal author non-byline.; Mtafya Bariki author non-byline.; Mwambola Harrieth author non-byline.; Minja Lilian author non-byline.; Sabi Issa author non-byline.; Edwin Peter author non-byline.; Ngalison Dogo author non-byline.; Luswema Stella author non-byline.; Olomi Willyhelmina author non-byline.; Pamba Doreen author non-byline.; Mwanyonga Simeon author non-byline.; Nhamuave Celina author non-byline.; Machiana António author non-byline.; Madeira Carla author non-byline.; Manhiça Emelva author non-byline.; Sitoe Nádia author non-byline.; Ribeiro Jorge author non-byline.; Geldmacher Christof author non-byline.; Rachow Andrea author non-byline.; Ivanova Olena author non-byline.; Olbrich Laura author non-byline.; Saathoff Elmar author non-byline.; Hoelscher Michael author non-byline.;
• Is Part Of: BMJ open. Volume 12:Issue 7(2022)
• Publication Date: 2022-07-19
• Subjects: Tuberculosis -- Diagnostic microbiology -- RESPIRATORY MEDICINE (see Thoracic Medicine); Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2022-060985
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: The WHO End-TB Strategy calls for the development of novel diagnostics to detect tuberculosis (TB) earlier and more accurately. Better diagnostics, together with tools to predict disease progression, are critical for achieving WHO End-TB targets. The E arly R isk A ssessment in TB Contacts by new diagnoS tic tE sts (ERASE-TB) study aims to evaluate novel diagnostics and testing algorithms for early TB diagnosis and accurate prediction of disease progression among household contacts (HHCs) exposed to confirmed index cases in Mozambique, Tanzania and Zimbabwe. Methods and analysis: A total of 2100 HHCs (aged ≥10 years) of adults with microbiologically-confirmed pulmonary TB will be recruited and followed up at 6-month intervals for 18–24 months. At each time point, a WHO symptom screen and digital chest radiograph (dCXR) will be performed, and blood and urine samples will be collected. Individuals screening positive (WHO symptom screen or dCXR) will be requested to provide sputum for Xpert MTB/Rif Ultra. At baseline, HHCs will also be screened for HIV, diabetes (HbA1c), chronic lung disease (spirometry), hypertension and anaemia. Study outcomes will be coprevalent TB (diagnosed at enrolment), incident TB (diagnosed during follow-up) or no TB at completion of follow-up. Novel diagnostics will be validated using fresh and biobanked samples with a nested case–control design. Cases are defined as HHCs diagnosed with TB (for early diagnosis) or with incident TB (for prediction of progression) and will be matched by age, sex and country to HHCs who remain healthy (controls). Statistical analyses will include assessment of diagnostic accuracy by constructing receiver operating curves and calculation of sensitivity and specificity. Ethics and dissemination: ERASE-TB has been approved by regulatory and ethical committees in each African country and by each partner organisation. Consent, with additional assent for participants <18 years, is voluntary. Attestation by impartial witnesses is sought in case of illiteracy. Confidentiality of participants is being maintained throughout. Study findings will be presented at scientific conferences and published in peer-reviewed international journals. Trial registration number: NCT04781257 .Cite Now