Effect of Xpert MTB/RIF on Patient Outcomes

NCT02729532 | Completed

• 2 other identifiers: 14-1697US NIH Grant P30 AI50410-17
• Study Type: observational
• Target: 776
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

Extra-pulmonary tuberculosis; multiple drug resistant tuberculosis; mycobacterium tuberculosis; human immunodeficiency virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 receive TB treatment within 14 days of enrolment (effect of Xpert on the accuracy of TB diagnosis)

  study enrolment to 14 days of 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

• Time to TB Diagnosis

  average of 28 days

• 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)

Study Arms (2)

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

Standard of Care cohort

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

Interventions

Xpert DEVICE

The Xpert MTB/RIF assay is a nucleic acid amplification (NAA) test that uses a disposable cartridge with the GeneXpert Instrument System

Also known as: Xpert MTB/RIF assay

Xpert cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• unwilling or unable to provide verbal informed consent in English

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Chelstone and Chilenje Health Centres

Lusaka, Zambia

Location

Related Publications (37)

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Related Links

• University of North Carolina website

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Extrapulmonary; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Michael Herce, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: April 6, 2016
• Study Start: June 22, 2016
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2018
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

ZA (1)