Finding and Treating Unsuspected and Resistant TB to Reduce Hospital Transmission

Not Applicable

• Conditions: Tuberculosis
• Interventions: Other: FAST

• Registration Number: NCT02355223
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2015-01-28
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-04
• Study Start: 2016-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11060

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FAST Implementation	FAST	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Hospital Nacional Hipolito Unanue; 🇵🇪 Lima, Peru