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Effect of Xpert MTB/RIF on Patient Outcomes

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ClinicalTrials.gov Identifier: NCT02729532
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date January 5, 2016
First Posted Date April 6, 2016
Last Update Posted Date April 22, 2019
Actual Study Start Date June 22, 2016
Actual Primary Completion Date February 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 31, 2016)		 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 ]
For both cohorts, the proportion of patients not started on TB treatment by 210 days post-enrolment will be assessed.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 31, 2016)
  • Time to TB treatment [ Time Frame: time in days from study enrolment to initiation of anti-TB therapy (ATT) (through 210 days post-enrolment) ]
  • 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 ]
    sensitivity of empirical TB diagnosis and treatment will be defined as the percentage of participants who received TB treatment within 14 days of enrolment among all those with a positive culture but negative or unavailable result for SM (for the SOC cohort), or negative or unavailable SM plus Xpert (for the Xpert cohort)
  • 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 ]
    the specificity of empirical treatment will be defined as the percentage of participants who did not receive TB treatment 14 days post-enrolment among all those with a negative culture and negative or unavailable result for SM (in the SOC cohort), or negative or unavailable result for SM plus Xpert (in the Xpert cohort)
  • Time to TB Diagnosis [ Time Frame: average of 28 days ]
    The World Health Organization definition of a TB case will be used
  • 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) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Xpert MTB/RIF on Patient Outcomes
Official Title 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
Brief Summary A parallel-group prospective cohort study among adult persons living with HIV/AIDS to study the effect of a new TB diagnostic test, Xpert MTB/RIF on: 1) TB case detection; 2) time to TB diagnosis and TB treatment; 3) presumptive TB patient drop-out from the TB diagnostic "cascade" before starting TB treatment; and 4) loss to follow-up after initiation of TB treatment.
Detailed Description

The Centre for Infectious Disease Research in Zambia (CIDRZ) in collaboration with the Zambian National TB Program (NTP) and the Ministry of Health (MOH) will provide near point-of-care Xpert testing at a high-volume anti-retroviral treatment (ART) clinic in Lusaka, Zambia. A total 892 study participants will be enrolled into two parallel cohorts-an "Xpert" and a "standard of care" (SOC) cohort over a 7-month period. The Xpert cohort will enrol participants at the health centre implementing Xpert. The SOC cohort will enrol participants from one health centre offering the standard of care (sputum smear microscopy plus clinical evaluation). A parallel-group prospective cohort study will be conducted by following participants in one cohort from each site for 210 days from the time of sputum submission, allowing sufficient person-time to observe all outcomes of interest, including completion of a standard course of ATT as well as patient drop-out and loss to follow-up.

A systematic facility assessment survey using an adapted version of the WHO Service Availability and Readiness Assessment tool will be conducted. Key informants will be interviewed.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult presumptive TB patients 18 years or older with documented HIV-positive sero-status presenting for routine HIV care at two health centres in Lusaka, Zambia.
Condition Tuberculosis
Intervention Device: Xpert
The Xpert MTB/RIF assay is a nucleic acid amplification (NAA) test that uses a disposable cartridge with the GeneXpert Instrument System
Other Name: Xpert MTB/RIF assay
Study Groups/Cohorts
  • Xpert cohort
    HIV-positive presumptive TB patients tested for TB using Xpert MTB/RIF assay (fluorescence microscopy and TB culture also done to serve as reference standard)
    Intervention: Device: Xpert
  • Standard of Care cohort
    HIV-positive presumptive TB patients tested for TB using standard of care testing (sputum smear microscopy plus clinical evaluation)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 19, 2019)		 776
Original Estimated Enrollment
 (submitted: March 31, 2016)		 892
Actual Study Completion Date February 9, 2018
Actual Primary Completion Date February 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Zambia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02729532
Other Study ID Numbers 14-1697
US NIH Grant P30 AI50410-17 ( Other Grant/Funding Number: US NIH )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University of North Carolina, Chapel Hill
Original Responsible Party Michael Herce, MD, MPH, University of North Carolina, Chapel Hill, Research Assistant Professor
Current Study Sponsor University of North Carolina, Chapel Hill
Original Study Sponsor Same as current
Collaborators National Institutes of Health (NIH)
Investigators
Principal Investigator: Michael Herce, MD, MPH University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date April 2019