Effect of Xpert MTB/RIF on Patient Outcomes

Completed

• Conditions: Tuberculosis
• Interventions: Device: Xpert

• Registration Number: NCT02729532
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Study Start: 2016-06-22
• Primary Completion: 2018-02-09
• Study Completion: 2018-02-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 776

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Xpert cohort	Xpert	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)

Primary Outcome Measures

Name	Time	Method
Culture-positive patient drop-out before accessing treatment	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

Name	Time	Method
Time to TB treatment	time in days from study enrolment to initiation of anti-TB therapy (ATT) (through 210 days post-enrolment)
Percentage of participants who did not receive TB treatment 14 days post-enrolment (effect of Xpert on the accuracy of TB diagnosis)	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)
Percentage of participants who receive TB treatment within 14 days of enrolment (effect of Xpert on the accuracy of TB diagnosis)	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)
Time to TB Diagnosis	average of 28 days	The World Health Organization definition of a TB case will be used
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)

Trial Locations

Locations (1)

Chelstone and Chilenje Health Centres; 🇿🇲 Lusaka, Zambia