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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02043080 |
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Date of registration:
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16/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Optimizing Clinical Outcomes in HIV-Infected Adults & Children
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Scientific title:
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CIDRZ 1201 - Optimizing Clinical Outcomes in HIV-Infected Adults & Children Using Xpert MTB/RIF in Zambia |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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1436 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02043080 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Zambia
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Contacts
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Name:
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Stewart Reid, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina |
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Key inclusion & exclusion criteria
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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)
Age minimum:
N/A
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Tuberculosis Diagnosis
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Intervention(s)
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Other: Xpert MTB/RIF Tuberculosis diagnostic tool
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Primary Outcome(s)
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Proportions of adult and paediatric patients receiving appropriate TB treatment in each study phase
[Time Frame: within 4 weeks of initiation]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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