Evaluating new point-of-care tests for tuberculosis diagnosis

Supporting, Mobilizing and Accelerating Research for Tuberculosis Elimination (SMART4TB)- Technical Area (TA) 1: Diagnostics- Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT)

This study is testing new quick tests for tuberculosis to see if they can help find more cases in people who show symptoms or are at risk, especially in countries where TB is common.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1350 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (other)
• Locations: 3 sites (Abuja and 2 other locations)
• Trial ID: NCT05941052 on ClinicalTrials.gov

What this trial studies

The ADAPT initiative aims to assess innovative point-of-care diagnostic tests for tuberculosis (TB) to improve detection rates in high-burden countries. By focusing on non-sputum biomarker-based tests, the study seeks to bridge the diagnostic gap that leaves many TB cases undiagnosed. Participants will include adolescents and adults with symptoms or risk factors for TB, and the tests will be evaluated against established standards like sputum Xpert® and culture methods. Usability and acceptability of these tests will also be measured through health worker observations and surveys.

Who should consider this trial

Good fit: Ideal candidates are non-hospitalized adults aged 12 and older with a cough lasting more than two weeks or specific risk factors for TB.

Not a fit: Patients who have completed TB treatment within the past 12 months will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to faster and more accessible TB diagnoses, ultimately saving lives and reducing transmission.

How similar studies have performed: Other studies have shown promise in improving TB diagnostics, but the specific approach of this study is innovative and aims to fill a critical gap.

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

Where this trial is running

Abuja and 2 other locations

• Zankli Research Center, Bingham University — Abuja, Nigeria (RECRUITING)
• De La Salle Medical and Health Sciences Institute — Dasmariñas, Philippines (RECRUITING)
• Centre for Infectious Disease Research in Zambia — Lusaka, Zambia (RECRUITING)

Study contacts

• Principal investigator: Adithya Cattamanchi — University of California, Irvine
• Study coordinator: Adithya Cattamanchi

Conditions: Tuberculosis, Diagnostics, Global Health