Effect of Xpert MTB/RIF on Patient Outcomes

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729532
• Other study ID #: 14-1697
• Secondary ID: US NIH Grant P30
• Status: Completed
• Start date: June 22, 2016
• Est. completion date: February 9, 2018

Study information

• Verified date: April 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 776
• Est. completion date: February 9, 2018
• Est. primary completion date: February 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Zambia	Chelstone and Chilenje Health Centres	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institutes of Health (NIH)

Country where clinical trial is conducted

Zambia, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Culture-positive patient drop-out before accessing treatment	For both cohorts, the proportion of patients not started on TB treatment by 210 days post-enrolment will be assessed.	From study enrolment through confirmed drop out date at or before 210-days post enrollment
Secondary	Time to TB treatment		time in days from study enrolment to initiation of anti-TB therapy (ATT) (through 210 days post-enrolment)
Secondary	Percentage of participants who receive TB treatment within 14 days of enrolment (effect of Xpert on the accuracy of TB diagnosis)	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)	study enrolment to 14 days of enrolment
Secondary	Percentage of participants who did not receive TB treatment 14 days post-enrolment (effect of Xpert on the accuracy of TB diagnosis)	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)	study enrolment to 14 days of enrolment
Secondary	Time to TB Diagnosis	The World Health Organization definition of a TB case will be used	average of 28 days
Secondary	Number of TB patients lost to follow-up		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)

External Links

•   University of North Carolina website