Optimizing Clinical Outcomes in HIV-Infected Adults & Children
NCT ID: NCT02043080
Last Updated: 2017-08-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
1436 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-08-31
Study Completion Date
2017-04-30
Brief Summary
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This is a study to evaluate Xpert MTB/RIF as the first-line TB diagnostic test in HIV-infected adults and pediatric patients as a means to obtain faster, more accurate TB diagnosis.
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Detailed Description
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This study will evaluate Xpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) as the first-line Tuberculosis (TB) diagnostic test in Human Immunodeficiency Virus (HIV)-infected adults and pediatric patients in peri-urban settings and determine its impact on accurate case detection and treatment initiation in these settings. In addition, the Determine TB-Lipoarabinomannan (LAM) Ag® will be used to model added diagnostic value when used alone or in combination with Xpert MTB/RIF, within the TB diagnostic algorithm for HIV infected patients in Zambia.
A quasi-experimental "before-after" study design will be used at two similar peri-urban district hospitals. Each site will initially implement the Standard of Care (SOC) phase, in which a prospective cohort of HIV-infected adult and pediatric TB suspects will be screened for TB according to the current standard of care in Zambian HIV care clinics. This will be followed by a 4-week "intervention wash-out" period to allow completion of the diagnostic work-up of all patients recruited during the last month of the SOC phase.
The second phase (Xpert MTB/RIF phase) will start immediately following the "intervention wash-out" period. In this phase, a second cohort of HIV-infected adult and pediatric TB suspects will be screened for TB using the Xpert MTB/RIF algorithm. Each phase will last approximately 6 months, or until the target sample size for adults is reached. Mycobacterial culture will be performed during the study to confirm TB diagnosis and determine whether appropriate treatment was given. "Appropriate treatment" means the patient was initiated on ATT within 4 weeks of screening initiation for culture-positive patients or a correct diagnosis of not having TB in culture-negative patients. Culture results will be released from the CIDRZ Lab for patient care as soon as results are available.
During both study phases participants will be asked to submit a urine sample for testing with the Determine TB-LAM Ag® assay. Urine specimens will be collected at the study site and all procedures will be carried out at the CIDRZ Central Laboratory in Lusaka using standard laboratory protocols and quality assurance procedures. Since Determine TB-LAM Ag® has not yet been endorsed by the World Health Organization (WHO) nor approved by the Zambian Ministry of Health for TB diagnosis, results from the Determine TB-LAM Ag® assay will not be used for patient care.
A quasi-experimental "before-after" study design will be used at two similar peri-urban district hospitals. Each site will initially implement the Standard of Care (SOC) phase, in which a prospective cohort of HIV-infected adult and pediatric TB suspects will be screened for TB according to the current standard of care in Zambian HIV care clinics. This will be followed by a 4-week "intervention wash-out" period to allow completion of the diagnostic work-up of all patients recruited during the last month of the SOC phase.
The second phase (Xpert MTB/RIF phase) will start immediately following the "intervention wash-out" period. In this phase, a second cohort of HIV-infected adult and pediatric TB suspects will be screened for TB using the Xpert MTB/RIF algorithm. Each phase will last approximately 6 months, or until the target sample size for adults is reached. Mycobacterial culture will be performed during the study to confirm TB diagnosis and determine whether appropriate treatment was given. "Appropriate treatment" means the patient was initiated on ATT within 4 weeks of screening initiation for culture-positive patients or a correct diagnosis of not having TB in culture-negative patients. Culture results will be released from the CIDRZ Lab for patient care as soon as results are available.
During both study phases participants will be asked to submit a urine sample for testing with the Determine TB-LAM Ag® assay. Urine specimens will be collected at the study site and all procedures will be carried out at the CIDRZ Central Laboratory in Lusaka using standard laboratory protocols and quality assurance procedures. Since Determine TB-LAM Ag® has not yet been endorsed by the World Health Organization (WHO) nor approved by the Zambian Ministry of Health for TB diagnosis, results from the Determine TB-LAM Ag® assay will not be used for patient care.
Conditions
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Tuberculosis Diagnosis
HIV
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
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SOC: sputum smear and Chest x-ray
HIV-infected adult and pediatric TB suspects screened for TB according to current standard of care
Group Type
NO_INTERVENTION
No interventions assigned to this group
Xpert MTB/RIF, sputum, chest xray &TB culture
HIV-infected adult and pediatric TB suspects screened for TB using the Xpert MTB/RIF Tuberculosis diagnostic tool (algorithm) which include chest x-ray, sputum TB culture
Group Type
EXPERIMENTAL
Xpert MTB/RIF Tuberculosis diagnostic tool
Intervention Type
OTHER
This is s new diagnostic tool that has been approved by WHO for the diagnosis of TB in HIV-infected patients in resource limited settings
Interventions
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Xpert MTB/RIF Tuberculosis diagnostic tool
This is s new diagnostic tool that has been approved by WHO for the diagnosis of TB in HIV-infected patients in resource limited settings
Intervention Type
OTHER
Other Intervention Names
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Gene Xpert MTB RIF (Cepheid Inc)
Eligibility Criteria
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Inclusion Criteria
* Aged 15 years or above ("Adult"), or less than 15 years old ("Child") ;
* HIV-infected and enrolled in HIV care at Chongwe and Kafue District Hospitals
* Intends to continue receiving care at the district hospital for at least 6 months.
* TB suspects according to Zambian National Guidelines \[31\] ;
* Willing to provide signed informed consent (or parental consent, if the participant is under 18);
* Willing (or parent or guardian willing) to provide locator information and allow contact by phone or home visit
* HIV-infected and enrolled in HIV care at Chongwe and Kafue District Hospitals
* Intends to continue receiving care at the district hospital for at least 6 months.
* TB suspects according to Zambian National Guidelines \[31\] ;
* Willing to provide signed informed consent (or parental consent, if the participant is under 18);
* Willing (or parent or guardian willing) to provide locator information and allow contact by phone or home visit
Exclusion Criteria
* Diagnosed with TB within the last 6 months or taken TB treatment in the last 3 months
* Enrolled in another study which might interfere with study objectives (ex. TB-HAART)
* Enrolled in another study which might interfere with study objectives (ex. TB-HAART)
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Centers for Disease Control and Prevention
FED
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Stewart Reid, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
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Centre for Infectious Disease Research in Zambia
Lusaka, , Zambia
Site Status
Countries
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Zambia
References
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World Health Organization, Global Tuberculosis Control: WHO Report 2011. 2011:Geneva, Switzerland.
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BACKGROUND
Ayles H, Schaap A, Nota A, Sismanidis C, Tembwe R, De Haas P, Muyoyeta M, Beyers N; Peter Godfrey-Faussett for the ZAMSTAR Study Team. Prevalence of tuberculosis, HIV and respiratory symptoms in two Zambian communities: implications for tuberculosis control in the era of HIV. PLoS One. 2009;4(5):e5602. doi: 10.1371/journal.pone.0005602. Epub 2009 May 19.
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Reid, S.E., Unpublished Data: Enhanced TB Screening to determine the prevalence and incidence of TB in a cohort of HIV clinic patients in Lusaka, Zambia. 2012.
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Henostroza, G., Unpublished work: Enhancing TB Screening in Zambian Prisons. 2011.
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Reid MJ, Shah NS. Approaches to tuberculosis screening and diagnosis in people with HIV in resource-limited settings. Lancet Infect Dis. 2009 Mar;9(3):173-84. doi: 10.1016/S1473-3099(09)70043-X.
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Reference Type
BACKGROUND
Lusaka Urban District Health Management Team, Annual Tuberculosis Report. 2009.
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Turnbull ER, Kaunda K, Harris JB, Kapata N, Muvwimi MW, Kruuner A, Henostroza G, Reid SE. An evaluation of the performance and acceptability of three LED fluorescent microscopes in Zambia: lessons learnt for scale-up. PLoS One. 2011;6(11):e27125. doi: 10.1371/journal.pone.0027125. Epub 2011 Nov 4.
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World Health Organization, Roadmap for rolling out Xpert MTB/RIF for rapid diagnosis of TB and MDR-TB. 2010.
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Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
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Nicol MP, Workman L, Isaacs W, Munro J, Black F, Eley B, Boehme CC, Zemanay W, Zar HJ. Accuracy of the Xpert MTB/RIF test for the diagnosis of pulmonary tuberculosis in children admitted to hospital in Cape Town, South Africa: a descriptive study. Lancet Infect Dis. 2011 Nov;11(11):819-24. doi: 10.1016/S1473-3099(11)70167-0. Epub 2011 Jul 19.
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BACKGROUND
Policy Statement: Automated Real-Time Nucleic Acid Amplification Technology for Rapid and Simultaneous Detection of Tuberculosis and Rifampicin Resistance: Xpert MTB/RIF System. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK304235/
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Marlowe EM, Novak-Weekley SM, Cumpio J, Sharp SE, Momeny MA, Babst A, Carlson JS, Kawamura M, Pandori M. Evaluation of the Cepheid Xpert MTB/RIF assay for direct detection of Mycobacterium tuberculosis complex in respiratory specimens. J Clin Microbiol. 2011 Apr;49(4):1621-3. doi: 10.1128/JCM.02214-10. Epub 2011 Feb 2.
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Badri M, Wilson D, Wood R. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Lancet. 2002 Jun 15;359(9323):2059-64. doi: 10.1016/S0140-6736(02)08904-3.
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Zambia Ministry of Health National Tuberculosis and Leprosy Control Programme, Tuberculosis and TB/HIV Manual. 2008: Lusaka.
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World Health Organization, Rapid Implementation of the Xpert MTB/RIF diagnostic test: Technical and operational 'How-to' Practical considerations. 2011.
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Related Links
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http://www.unc.edu
University of North Carolina website
Other Identifiers
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12-1402
Identifier Type: -
Identifier Source: org_study_id
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