Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission

Study Overview
=================
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.

Official Title
-----------------
Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Other: FAST


Participation Criteria
=================
Eligibility Criteria
-----------------
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 exclusion criteria at initial screening if the patient meets the above inclusion criteria. Inclusion Criteria (for health care workers): being an employee or intern at Hospital Nacional Hipolito Unanue (HNHU), Hospital Nacional Arzobispo Loayza (HNAL) or Hospital Nacional Sergio Bernales (HNSB) and deemed to be at risk of exposure to tuberculosis based on line of work age ≥ 18 years willing and able to provide informed consent for participation Exclusion Criteria (for health care workers): no specific exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FAST Implementation<br>This single center study will consist of introducing a TB screening program called FAST (Find cases Actively, Separate safely, and Treat Effectively) within the hospital among patients presenting for care who have cough or TB risk factors, and testing them for tuberculosis using a combination of rapid screening and diagnostics tools. The study will evaluate the process of implementation as well as the impact on reducing tuberculosis transmission to health care workers over successive years. | Other: FAST<br>* See information in arm description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of time to TB diagnosis and treatment for patients and TB infection rates in health care workers. | Time to diagnosis and Time to effective treatment initiation | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Sensitivity and specificity of EBT and dCXR/CAD4TB will be calculated along with negative predictive value | 5 years | 
| Costs and cost-effectiveness of FAST | Cost effectiveness analysis | 5 years | 
| Acceptability of FAST, novel screening strategies, and health care worker testing for latent tuberculosis. | Qualitative data collection using surveys and focus groups to assess acceptability and barriers | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis, Infection Control, Transmission