Assessing Diagnostics At Point-of-care for Tuberculosis

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Jul 3, 2023

Keywords

ClinConnect Summary

The ADAPT study is a clinical trial aimed at finding better ways to diagnose tuberculosis (TB), a serious disease that affects millions of people worldwide. Researchers are looking at new, faster, and less expensive tests that can be done right where patients are being treated, rather than in a lab. This is important because every year, many people with TB go undiagnosed, leading to severe health consequences.

To be part of this study, participants need to be at least 12 years old and have either a cough lasting more than two weeks or certain risk factors for TB, like having HIV or a history of close contact with someone who has TB. Participants will receive TB screening and may need to return for follow-up visits. Health workers who are involved in TB testing at the study sites can also participate. The goal is to make diagnosing TB easier, which could help save lives and reduce the spread of this disease.

Gender

ALL

Eligibility criteria

• Novel TB triage and diagnostic tests:
• • Inclusion Criteria-
• The investigators will include non-hospitalized adults (age ≥ 12 years) with either:
• • 1. cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups; OR
• 2. risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:
• Positive TB screening definitions by risk factor:
• • 1. People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) \>5 mg/dL OR abnormal chest x-ray (CXR)
• • 2. Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR
• • Exclusion Criteria-
• • 1. Completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
• • 2. Have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);
• • 3. Reside \>20km from the study site or are unwilling to return for follow-up visits; OR
• • 4. Are unwilling to provide informed consent
• Assessment of the usability of novel TB tests:
• • Inclusion Criteria-
• The investigators will include health workers at each clinical site who are:
• • 1. aged ≥18 years; AND
• • 2. involved in routine TB testing (collecting specimens for or performing TB tests).
• • Exclusion Criteria-
• The investigators will exclude staff who are:
• • 1) unwilling to provide informed consent