Optimizing Clinical Outcomes in HIV-Infected Adults & Children
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||CIDRZ 1201 - Optimizing Clinical Outcomes in HIV-Infected Adults & Children Using Xpert MTB/RIF in Zambia|
- Proportions of adult and paediatric patients receiving appropriate TB treatment in each study phase [ Time Frame: within 4 weeks of initiation ] [ Designated as safety issue: No ]proportions of adult and paediatric 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
- 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 ] [ Designated as safety issue: No ]
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)
- Diagnostic performance of Xpert MTB/RIF [ Time Frame: screening visit, 3 and 6 months post screening ] [ Designated as safety issue: No ]Sensitivity, specificity, positive and negative predictive values of TB diagnosis with Xpert MTB/RIF compared to culture will be calculated.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
No Intervention: Standard of Care including 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 and TB culture
HIV-infected adult and pediatric TB suspects screened for TB using the Xpert MTB/RIF 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 Name: Gene Xpert MTB RIF (Cepheid Inc)
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 paediatric 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 paediatric 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 paediatric 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02043080
|Contact: Margaret Kasaro, MBChB||260 email@example.com|
|Centre for Infectious Disease Research in Zambia||Recruiting|
|Contact: Nzali Kancheya, MBChB, MMED 260 977779700|
|Principal Investigator:||Stewart Reid, MD||University of North Carolina|