Clinical trial NCT02729532: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Extra-pulmonary tuberculosis
multiple drug resistant tuberculosis
mycobacterium tuberculosis
human immunodeficiency virus
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2016-04-06
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Culture-positive patient drop-out before accessing treatment
timeFrame: From study enrolment through confirmed drop out date at or before 210-days post enrollment
Secondary outcomes:
measure: Time to TB treatment
timeFrame: time in days from study enrolment to initiation of anti-TB therapy (ATT) (through 210 days post-enrolment)
measure: Percentage of participants who receive TB treatment within 14 days of enrolment (effect of Xpert on the accuracy of TB diagnosis)
timeFrame: study enrolment to 14 days of enrolment
measure: Percentage of participants who did not receive TB treatment 14 days post-enrolment (effect of Xpert on the accuracy of TB diagnosis)
timeFrame: study enrolment to 14 days of enrolment
measure: Time to TB Diagnosis
timeFrame: average of 28 days
measure: Number of TB patients lost to follow-up
timeFrame: 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)
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Chelstone and Chilenje Health Centres
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael Herce, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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