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Completed

NCT Number: NCT02729532

Effect of Xpert MTB/RIF on Patient Outcomes

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chelstone and Chilenje Health Centres

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xpert

Device

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

Other names: Xpert MTB/RIF assay

Primary outcomes

  1. Culture-positive patient drop-out before accessing treatment

    Time frame: 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 outcomes

  1. Time to TB treatment

    Time frame: time in days from study enrolment to initiation of anti-TB therapy (ATT) (through 210 days post-enrolment)

  2. Percentage of participants who receive TB treatment within 14 days of enrolment (effect of Xpert on the accuracy of TB diagnosis)

    Time frame: 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)

  3. Percentage of participants who did not receive TB treatment 14 days post-enrolment (effect of Xpert on the accuracy of TB diagnosis)

    Time frame: 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)

  4. Time to TB Diagnosis

    Time frame: average of 28 days

    The World Health Organization definition of a TB case will be used

  5. Number of TB patients lost to follow-up

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2016
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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