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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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12 December 2020 |
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Main ID: |
NCT02729532 |
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Date of registration:
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05/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Xpert MTB/RIF on Patient Outcomes
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Scientific title:
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Z 31411 - The Effect of Xpert MTB/RIF on Patient Health Outcomes and Empirical TB Treatment Among Persons Living With HIV/AIDS: A Parallel-Group Prospective Cohort Study Under Real-World Conditions in Lusaka, Zambia |
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Date of first enrolment:
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June 22, 2016 |
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Target sample size:
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776 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02729532 |
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Study type:
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Observational |
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Study design:
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Phase:
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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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Michael Herce, MD, MPH |
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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, Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Able to spontaneously expectorate at least 2 sputum samples, in accordance with NTP
guidelines
- Intend to continue receiving care at the respective study sites for at least 7 months
- Willing to provide locator information and allow contact by phone or home visit in the
case of loss to follow up after initiating ATT
Exclusion Criteria:
- Received TB treatment within 60 days prior to enrolment and/or were diagnosed with TB
within the last 6 months
- Cannot spontaneously expectorate sputum
- Are already enrolled in another study with might interfere with implementation of this
study protocol
- Provided a sputum sample that results in a contaminated TB culture result
A key informant will be eligible for inclusion in the SARA facility survey component of the
study if they meet the following criteria:
- 18 years of age or older
- clinic staff member at either Chilenje Health Centre or Chelstone Health Centre
- have previously been attached to, or are otherwise familiar with, departments offering
HIV, TB and/or laboratory health services
Exclusion criteria:
-unwilling or unable to provide verbal informed consent in English
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tuberculosis
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Intervention(s)
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Device: Xpert
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Primary Outcome(s)
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Culture-positive patient drop-out before accessing treatment
[Time Frame: From study enrolment through confirmed drop out date at or before 210-days post enrollment]
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Secondary Outcome(s)
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Time to TB Diagnosis
[Time Frame: average of 28 days]
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Percentage of participants who receive TB treatment within 14 days of enrolment (effect of Xpert on the accuracy of TB diagnosis)
[Time Frame: study enrolment to 14 days of enrolment]
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Number of TB patients lost to follow-up
[Time Frame: The number of patients will be measured as time in days from study enrolment to confirmed drop out (confirmed as failure noted at 3 and 6 month chart review)]
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Percentage of participants who did not receive TB treatment 14 days post-enrolment (effect of Xpert on the accuracy of TB diagnosis)
[Time Frame: study enrolment to 14 days of enrolment]
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Time to TB treatment
[Time Frame: time in days from study enrolment to initiation of anti-TB therapy (ATT) (through 210 days post-enrolment)]
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Secondary ID(s)
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14-1697
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US NIH Grant P30 AI50410-17
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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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