Tuberculosis
Conditions
Keywords
Tuberculosis, Infection Control, Transmission
Brief summary
The study is designed to evaluate the clinical impact of a novel strategy for tuberculosis (TB) infection control known as FAST (Find cases Actively based on cough surveillance, Separate temporarily, and Treat effectively). It is anticipated that this will decrease time to effective treatment initiation and also decrease transmission of TB to health care workers.
Detailed description
There is longstanding evidence that tuberculosis (TB) transmission is not from TB patients on effective treatment, but from unsuspected cases, and cases with unsuspected drug resistance. This study seeks to investigate the implementation of a refocused TB transmission control approach that we call FAST (Find cases Actively based on cough surveillance, Separate temporarily, and Treat effectively based on molecular drug-susceptibility testing \[DST\]). We will conduct this study at Hospital Nacional Hipólito Unanue in Lima, Peru. Our hypothesis is that FAST will reduce delays in identifying infectious TB patients (and unsuspected drug resistance) entering the hospital, facilitate timely effective therapy, and thereby reduce the risk of TB transmission in a cost-effective manner. We will assess the impact of FAST on TB transmission by evaluating IGRA conversions among health care workers at the intervention site, Hospital Nacional Hipolito Unanue (HNHU), and two control sites, Hosptial Nacional Arzobispo Loayza (HNAL) and Hospital Nacional Sergio Bernales (HNSB). We will also evaluate acceptability and barriers to/facilitators of FAST, novel screening strategies, and health care worker IGRA testing using a mixed methods approach.
Interventions
OTHERFAST
See information in arm description
Sponsors
Hospital Nacional Hipólito Unanue
Socios En Salud Sucursal, Peru
Hospital Nacional Arzobispo Loayza
Hospital Nacional Sergio Bernales
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(for patients): * adult (≥ 18 years) patients who are receiving care in the emergency department or being admitted for inpatient care from any other hospital area * patient presenting with cough or TB risk factors of prior or current TB diagnosis and/or contact of an individual with TB * able to participate by providing a sputum sample and/or exhaled breath test sample
Exclusion criteria
(for patients): * no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of time to TB diagnosis and treatment for patients and TB infection rates in health care workers. | 5 years | Time to diagnosis and Time to effective treatment initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of a novel exhaled breath test (EBT) and digital chest X-ray with computer assisted detection (dCXR/CAD4TB) as rule-out screening tests for tuberculosis in coughing patients | 5 years | Sensitivity and specificity of EBT and dCXR/CAD4TB will be calculated along with negative predictive value |
| Costs and cost-effectiveness of FAST | 5 years | Cost effectiveness analysis |
| Acceptability of FAST, novel screening strategies, and health care worker testing for latent tuberculosis. | 5 years | Qualitative data collection using surveys and focus groups to assess acceptability and barriers |
Countries
Peru
Contacts
Primary ContactEdward Nardell, MD
Backup ContactDylan Tierney, MD
Outcome results
None listed