Chepetsa TB - Reducing TB Among HIV-Infected Malawians
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ClinicalTrials.gov Identifier: NCT01450085 |
Recruitment Status
:
Completed
First Posted
: October 12, 2011
Last Update Posted
: August 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tuberculosis | Other: GeneXpert Other: LED Microscopy | Not Applicable |
HIV and tuberculosis (TB) are, along with malaria, the leading infectious causes of death worldwide and in sub-Saharan Africa.1 In 2008, there were 2 million deaths from AIDS and 1.8 million deaths from TB worldwide.2, 3 The HIV epidemic has fueled an increase in the incidence of, prevalence of and mortality due to TB in the past 3 decades. 15% of TB cases are HIV co-infected worldwide.34 78% of HIV-infected TB cases are in Africa.3 TB is the leading cause of death and opportunistic infection among persons living with HIV/AIDS (PLWHA). The HIV epidemic has challenged time-tested TB control methods that are now failing in high HIV prevalence settings.5 The World Health Organization (WHO) has recommended that the Three I's - intensified case-finding for TB (ICF), isoniazid preventive therapy (IPT) and infection control for TB - be targeted at PLWHA.6 ICF and IPT have not been adequately implemented in part due to the absence of sensitive, specific and rapid TB tests. The Cepheid GeneXpert System, a new diagnostic test for TB, is a self-contained sputum-processing and real-time PCR system to detect the M. tuberculosis complex as well as rifampin resistance.78 The GeneXpert is rapid, highly sensitive and specific, can be used as a point-of-care test, and has low human resource, laboratory and infection control requirements.7, 8 The WHO Strategic and Advisory Group for TB has endorsed recommendations for widespread use of the GeneXpert.9 WHO strongly recommended that the GeneXpert should be used as the initial diagnostic test in HIV-infected TB suspects and multidrug-resistant TB (MDR-TB) suspects.9 WHO also recommended that implementation of the GeneXpert be phased in within the context of comprehensive national and MDR-TB strategic plans.9 WHO recognized that several operational conditions need to be met for successful implementation, including but not limited to stable electrical supply, security against theft, trained personnel and annual calibration of the instrument by a commercial supplier.9 WHO also noted that it is important to document the impact and cost-effectiveness of the GeneXpert for TB case detection.9
Trial Concept The overall objective of this proposal is to conduct a cluster-randomized trial of the relative impact and cost-effectiveness of a routine TB screening algorithm -- symptom screening and point-of-care LED fluorescence sputum smear microscopy - versus a GeneXpert-based TB screening algorithm - symptom screening and point-of-care GeneXpert testing - on reducing morbidity and mortality due to TB among HIV-infected Malawians. 12 public sector clinics in southern Malawi will be randomized to 1 of 2 algorithms for TB case detection as part of ICF and for exclusion of TB prior to IPT and antiretroviral therapy (ART) initiation. In the clinics assigned to the GeneXpert algorithm, newly diagnosed HIV-infected patients will be screened for symptoms of TB and, if symptomatic, will provide sputum for GeneXpert point-of-care TB testing. Under the routine screening algorithm, patients at a clinic will be screened for symptoms of TB and, if symptomatic, will provide sputum for point-of-care LED fluorescence smear microscopy. The current standard of care in Malawi and most of Africa is symptom screening and sputum smear microscopy using Ziehl-Neelsen stain (not LED fluorescence microscopy) alone. There is not sufficient evidence at this time to demonstrate whether point-of-care LED microscopy versus GeneXpert testing is likely to be superior with respect to clinical impact and/or cost-effectiveness. Outcomes will be measured at the clinic level.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Impact of a New Molecular Tuberculosis (TB) Test on TB/HIV Outcomes Among HIV- |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 30, 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: GeneXpert
Point of care GeneXpert
|
Other: GeneXpert
Point of care GeneXpert
Other: LED Microscopy
Point of care LED Microscopy
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Active Comparator: LED Microscopy
Point of care LED Microscopy
|
Other: LED Microscopy
Point of care LED Microscopy
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- Survival of newly-diagnosed HIV-infected patients at 1 year [ Time Frame: 4 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All HIV-infected men and women > 18 years of age with newly diagnosed HIV at the 12 study clinics will be asked to participate in the study.
Exclusion Criteria:
- Patients will be excluded from participation if they have a current diagnosis of TB and/or if they are currently taking IPT, TB treatment and/or ART.
- Patients will also be excluded from participation if they cannot speak English or Chichewa;
- if they have a language or hearing impairment; or
- if they are prisoners.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450085
Malawi | |
Blantyre, Thyolo District, Malawi | |
Blantyre, Malawi |
Principal Investigator: | Elizabeth Corbett, MD | Malawi Liverpool Wellcome Trust | |
Study Director: | David Dowdy, MD. PhD | Johns Hopkins Unviversity | |
Principal Investigator: | Lawrence Moulton, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01450085 History of Changes |
Other Study ID Numbers: |
1R01AI093316-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | October 12, 2011 Key Record Dates |
Last Update Posted: | August 18, 2017 |
Last Verified: | August 2017 |
Additional relevant MeSH terms:
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |