Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

Inclusion Criteria17

• Participant eligibility criteria:
• Participants will include children (age \<15 years) who present to care with:
• A. 2 or more of the following:
• Unexplained cough for any duration
• TB contact or tuberculin skin test or interferon gamma release assay positive
• Abnormal chest X-ray (any abnormality) OR
• B. Any one of criteria A AND any one of the following:
• Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition
• Unexplained fever ≥2 weeks
• Unexplained lethargy or reduced playfulness ≥2 weeks
• The study will exclude participants who:
• Completed preventive or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
• Have taken any medication with anti-mycobacterial activity for any reason for greater than 3 days at the time of enrollment (to reduce false-negatives);
• Are unable to return for follow-up visits; or
• Whose parents/guardians are unwilling to provide informed consent or who are unwilling to provide assent if applicable (age determined by local IRB)
• Assessment of the usability of novel TB tests:
• The study will also 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). Personnel who are unwilling to provide informed consent will be excluded.