Optimizing Clinical Outcomes in HIV-Infected Adults & Children

August 2, 2017 updated by: University of North Carolina, Chapel Hill

CIDRZ 1201 - Optimizing Clinical Outcomes in HIV-Infected Adults & Children Using Xpert MTB/RIF in Zambia

This is a study to evaluate Xpert MTB/RIF as the first-line TB diagnostic test in HIV-infected adults and pediatric patients as a means to obtain faster, more accurate TB diagnosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate Xpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) as the first-line Tuberculosis (TB) diagnostic test in Human Immunodeficiency Virus (HIV)-infected adults and pediatric patients in peri-urban settings and determine its impact on accurate case detection and treatment initiation in these settings. In addition, the Determine TB-Lipoarabinomannan (LAM) Ag® will be used to model added diagnostic value when used alone or in combination with Xpert MTB/RIF, within the TB diagnostic algorithm for HIV infected patients in Zambia.

A quasi-experimental "before-after" study design will be used at two similar peri-urban district hospitals. Each site will initially implement the Standard of Care (SOC) phase, in which a prospective cohort of HIV-infected adult and pediatric TB suspects will be screened for TB according to the current standard of care in Zambian HIV care clinics. This will be followed by a 4-week "intervention wash-out" period to allow completion of the diagnostic work-up of all patients recruited during the last month of the SOC phase.

The second phase (Xpert MTB/RIF phase) will start immediately following the "intervention wash-out" period. In this phase, a second cohort of HIV-infected adult and pediatric TB suspects will be screened for TB using the Xpert MTB/RIF algorithm. Each phase will last approximately 6 months, or until the target sample size for adults is reached. Mycobacterial culture will be performed during the study to confirm TB diagnosis and determine whether appropriate treatment was given. "Appropriate treatment" means the patient was initiated on ATT within 4 weeks of screening initiation for culture-positive patients or a correct diagnosis of not having TB in culture-negative patients. Culture results will be released from the CIDRZ Lab for patient care as soon as results are available.

During both study phases participants will be asked to submit a urine sample for testing with the Determine TB-LAM Ag® assay. Urine specimens will be collected at the study site and all procedures will be carried out at the CIDRZ Central Laboratory in Lusaka using standard laboratory protocols and quality assurance procedures. Since Determine TB-LAM Ag® has not yet been endorsed by the World Health Organization (WHO) nor approved by the Zambian Ministry of Health for TB diagnosis, results from the Determine TB-LAM Ag® assay will not be used for patient care.

Study Type

Interventional

Enrollment (Actual)

1436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Centre for Infectious Disease Research in Zambia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 15 years or above ("Adult"), or less than 15 years old ("Child") ;
  • HIV-infected and enrolled in HIV care at Chongwe and Kafue District Hospitals
  • Intends to continue receiving care at the district hospital for at least 6 months.
  • TB suspects according to Zambian National Guidelines [31] ;
  • Willing to provide signed informed consent (or parental consent, if the participant is under 18);
  • Willing (or parent or guardian willing) to provide locator information and allow contact by phone or home visit

Exclusion Criteria:

  • Diagnosed with TB within the last 6 months or taken TB treatment in the last 3 months
  • Enrolled in another study which might interfere with study objectives (ex. TB-HAART)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: SOC: sputum smear and Chest x-ray
HIV-infected adult and pediatric TB suspects screened for TB according to current standard of care
EXPERIMENTAL: Xpert MTB/RIF, sputum, chest xray &TB culture
HIV-infected adult and pediatric TB suspects screened for TB using the Xpert MTB/RIF Tuberculosis diagnostic tool (algorithm) which include chest x-ray, sputum TB culture
Other: Xpert MTB/RIF Tuberculosis diagnostic tool
This is s new diagnostic tool that has been approved by WHO for the diagnosis of TB in HIV-infected patients in resource limited settings
Other Names:
  • Gene Xpert MTB RIF (Cepheid Inc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportions of adult and paediatric patients receiving appropriate TB treatment in each study phase
Time Frame: within 4 weeks of initiation
proportions of adult and pediatric patients receiving appropriate TB treatment in each study phase, using mycobacterial culture as the reference standard, and the feasibility and cost effectiveness of Xpert MTB/RIF in this setting
within 4 weeks of initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes of subjects screened using the Xpert MTB/RIF algorithm compared to existing standard of care.
Time Frame: 3 and 6 months post TB-screening

Clinical outcomes to be compared include (but are not limited to):

ART treatment start date CD4 response TB treatment outcomes at 6 months post-diagnosis Mortality Co-morbidities Other Opportunistic Infections Characteristics of TB patients who initially test Xpert negative (Xpert- /Culture + patients)
3 and 6 months post TB-screening

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of Xpert MTB/RIF
Time Frame: screening visit, 3 and 6 months post screening
Sensitivity, specificity, positive and negative predictive values of TB diagnosis with Xpert MTB/RIF compared to culture will be calculated.
screening visit, 3 and 6 months post screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Stewart Reid, MD, University of North Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2012

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (ESTIMATE)

January 23, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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