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Optimizing Clinical Outcomes in HIV-Infected Adults & Children

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT02043080
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
1,436
Enrollment
1
Location
2
Arms
56
Actual Duration (Months)
25.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Xpert MTB/RIF Tuberculosis diagnostic tool
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1436 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
CIDRZ 1201 - Optimizing Clinical Outcomes in HIV-Infected Adults & Children Using Xpert MTB/RIF in Zambia
Actual Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportions of adult and paediatric patients receiving appropriate TB treatment in each study phase [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

    Secondary Outcome Measures

    1. Clinical outcomes of subjects screened using the Xpert MTB/RIF algorithm compared to existing standard of care. [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)

    Other Outcome Measures

    1. Diagnostic performance of Xpert MTB/RIF [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Infectious Disease Research in Zambia Lusaka Zambia

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill
    • Centers for Disease Control and Prevention

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT02043080
    Other Study ID Numbers:
    • 12-1402
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Aug 3, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by University of North Carolina, Chapel Hill
    Tuberculosis
    HIV
    Xpert MTB/RIF
    Determine TB-LAM
    UNC
    Zambia
    Cost Effectiveness Analysis Curve
    Centre for Infectious Disease Research in Zambia
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of Aug 3, 2017