Effect of Xpert MTB/RIF on Patient Outcomes

University of North Carolina (UNC)

Status: Completed

Conditions: Tuberculosis

Treatments: Device: Xpert

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02729532

US NIH Grant P30 AI50410-17 (Other Grant/Funding Number)

14-1697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 776 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

776 participants in 2 patient groups

Xpert cohort

Description:

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)

Treatment:

Device: Xpert

Standard of Care cohort

Description:

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