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Acceptability and Feasibility of Home-based TB Testing

NCT04973371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2021-07-22

No results posted yet for this study

Summary

This study aims to evaluate the utility of home-based point-of-care TB testing for early diagnosis and linkage to care of household contacts of TB patients, addressing the need for active case finding and early detection of infectious TB. The investigators propose an exploratory study to 1) investigate the acceptability and feasibility of home-based TB testing of household contacts using a new portable GeneXpert point-of-care (PoC) platform, and 2) determine the potential impact of such a home-based testing program on early detection of TB disease and linkage-to-care (LTC).

Conditions

  • Tuberculosis, Pulmonary
  • Households

Interventions

DIAGNOSTIC_TEST

Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test

Those who screen positive for TB using the standard 4-question screener will be offered a GeneXpert® \[Cepheid, Sunnyvale, CA\] MTB/RIF test in their home with referral for clinic-based TB treatment initiation for those who receive a positive MTB/RIF test result.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • Medical Research Council, South Africa

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    collaborator OTHER

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • University of California, Irvine

    collaborator OTHER

  • Foundation for Professional Development (Pty) Ltd

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-05-31
Completion
2019-06-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04973371 on ClinicalTrials.gov