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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

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.

Condition or disease Intervention/treatment
Tuberculosis Device: Xpert

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.

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Study Type : Observational
Actual Enrollment : 776 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 22, 2016
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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

Standard of Care cohort
HIV-positive presumptive TB patients tested for TB using standard of care testing (sputum smear microscopy plus clinical evaluation)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to TB treatment [ Time Frame: time in days from study enrolment to initiation of anti-TB therapy (ATT) (through 210 days post-enrolment) ]
  2. 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)

  3. 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)

  4. Time to TB Diagnosis [ Time Frame: average of 28 days ]
    The World Health Organization definition of a TB case will be used

  5. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729532


Locations
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Zambia
Chelstone and Chilenje Health Centres
Lusaka, Zambia
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Michael Herce, MD, MPH University of North Carolina, Chapel Hill
Additional Information:
Publications:
World Health Organization. (2013). Global tuberculosis report 2013. Geneva: WHO.
Boehme, C. C. Oral Presentation, 20th Conference on Retroviruses and Opportunistic Infections. Georgia World Conference Centre, Atlanta, USA, March 3-6, 2013.
Office of the U.S. Global AIDS Coordinator. Scaling Up TB Prevention, Screening, Diagnosis and Care in Zambia: Implementing the WHO 3I's, Program Protocol. Lusaka: Centers for Disease Control and Prevention-Zambia, 2012.
UNAIDS. Global Report: UNAIDS report on the global AIDS epidemic 2013. Geneva: Joint United Nations Programme on HIV/AIDS, 2013.
Global Health Workforce Statistics, World Health Organization, Geneva. Accessed online at: http://www.who.int/hrh/statistics/hwfstats/ on November 24, 2013.
WHO. Guidelines for intensified tuberculosis case-finding and isoniazid preventative therapy for people living with HIV in resource-constrained settings. Geneva: World Health Organization, 2011.
WHO. Treatment of tuberculosis guidelines, 4th edition. Geneva: World Health Organization, 2010.
Global Laboratory Initiative. Laboratory diagnosis of tuberculosis by sputum microscopy: The handbook. Geneva: Global Laboratory Initiative, 2013.
WHO/TDR/FIND. Diagnostics for tuberculosis: Global demand and market potential. Geneva: World Health Organization, 2006.
Henostroza G, Harris J, Siyambango M, et al. High prevalence of tuberculosis among new HIV care enrolees in Zambia: urgent need for an enhanced screening approach. Oral presentation, 43rd World Conference on Lung Health. Kuala Lumpur Convention Centre, Kuala Lumpur, Malaysia. November 13 - 17, 2012.
Ministry of Health, Republic of Zambia. Managing Tuberculosis in the HIV Setting in Zambia. Lusaka: Ministry of Health, 2014.

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02729532    
Other Study ID Numbers: 14-1697
US NIH Grant P30 AI50410-17 ( Other Grant/Funding Number: US NIH )
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Keywords provided by University of North Carolina, Chapel Hill:
Extra-pulmonary tuberculosis
multiple drug resistant tuberculosis
mycobacterium tuberculosis
human immunodeficiency virus
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections