Enhanced TB Screening to Determine the Prevalence and Incidence of TB in Patients With HIV

Tuberculosis Clinical Trial

Official title:

Enhanced TB Screening to Determine the Prevalence and Incidence of TB in a Cohort of HIV Clinic Patients in Lusaka, Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043067
• Other study ID #: CIDRZ 1226/IRB12-0416
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: September 13, 2017
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: December 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).

Description:

Zambia is a high burden country for both HIV and TB infection and HIV clinic enrollees are a high-risk group for active TB. Current Zambian Ministry of Health screening protocols are symptom-based even though active case-finding studies in HIV-infected populations have shown that symptoms are not always predictive of active TB. As a result, there may be a significant amount of un-diagnosed TB among HIV-infected Zambians even in the context of accessing HIV care. This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of TB using symptoms, light and fluorescence microscopy, chest radiography and TB culture of sputum and extra-pulmonary fluids (when indicated). In addition, the sensitivity, specificity and cost-effectiveness of each diagnostic tool will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

Inclusion Criteria:

• Persons with HIV/AIDS, 16 years of age or older, who are enrolling at the Kalingalinga ART clinic and are able and willing to provide informed consent

• Antiretroviral therapy-naïve except for short-course therapy through prevention of mother-to-child-transmission programs

• Not have taken any TB treatment in the past 3 months

• Willing to provide locator information and allow study staff to contact by phone or visit them at home if required

Exclusion Criteria:

• Any condition, including active drug or alcohol use, which in the opinion of the investigators, would interfere with adherence to study requirements

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• Comprehensive TB screening
All enrollees will receive a comprehensive TB screening regardless of symptom presentation.

Locations

Country	Name	City	State
Zambia	Kalingalinga HIV Care and Treatment Clinic	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centers for Disease Control and Prevention, Centre for Infectious Disease Research in Zambia

Country where clinical trial is conducted

Zambia, 

References & Publications (27)

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Harris JB, Hatwiinda SM, Randels KM, Chi BH, Kancheya NG, Jham MA, Samungole KV, Tambatamba BC, Cantrell RA, Levy JW, Kimerling ME, Reid SE. Early lessons from the integration of tuberculosis and HIV services in primary care centers in Lusaka, Zambia. Int J Tuberc Lung Dis. 2008 Jul;12(7):773-9. — View Citation

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Lawn SD, Wilkinson RJ, Lipman MC, Wood R. Immune reconstitution and "unmasking" of tuberculosis during antiretroviral therapy. Am J Respir Crit Care Med. 2008 Apr 1;177(7):680-5. doi: 10.1164/rccm.200709-1311PP. Epub 2008 Jan 17. Review. — View Citation

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Mohammed A, Ehrlich R, Wood R, Cilliers F, Maartens G. Screening for tuberculosis in adults with advanced HIV infection prior to preventive therapy. Int J Tuberc Lung Dis. 2004 Jun;8(6):792-5. — View Citation

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Stringer JS, Zulu I, Levy J, Stringer EM, Mwango A, Chi BH, Mtonga V, Reid S, Cantrell RA, Bulterys M, Saag MS, Marlink RG, Mwinga A, Ellerbrock TV, Sinkala M. Rapid scale-up of antiretroviral therapy at primary care sites in Zambia: feasibility and early outcomes. JAMA. 2006 Aug 16;296(7):782-93. — View Citation

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Theron G, Peter J, van Zyl-Smit R, Mishra H, Streicher E, Murray S, Dawson R, Whitelaw A, Hoelscher M, Sharma S, Pai M, Warren R, Dheda K. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary tuberculosis in a high HIV prevalence setting. Am J Respir Crit Care Med. 2011 Jul 1;184(1):132-40. doi: 10.1164/rccm.201101-0056OC. Epub 2011 Apr 14. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Performance of diagnostic measures	The performance of symptom screening, light microscopy, fluorescence microscopy, chest x-ray, and Xpert MTB/RIF assay compared to culture of sputum and other fluids in HIV-infected patients will be evaluated using data analysis methods.	Days 1, 2, 3; Months 3, 6 9 and 12
Other	Cost-effectiveness of each screening/diagnostic tool.	The primary outcomes of each diagnostic tool (or combination of diagnostic tools) that will be assessed are: cost per case diagnosed/detected, cost per patient cured, cost per case averted. For instance, the cost per case of active TB detected using the "null" or gold standard screening option will be calculated and compared to the cost per case of active TB detected using each of the other screening options.	Days 1, 2, 3 and months 3, 6, 9 and 12
Other	Clinical outcomes	Clinical outcomes will be measured in a cohort of HIV-infected patients and TB/HIV co-infected patients during the first 12 months of HIV care including but not limited to mortality, immune recovery and development of other opportunistic infections.	up to 12 months post-enrollment
Primary	Prevalence of undiagnosed TB in those with HIV.	Among the cohort of 400 new enrollees at the clinic, all will be tested for TB at the specified time points using enhanced TB screening. Initial diagnosis will use smear microscopy and culture. Chest X-ray will be performed on the second day of enrollment. Presumptive Diagnosis: As culture results will take several days or weeks to become available, a presumptive diagnosis will be made based on history and physical exam, symptoms, smear microscopy and chest radiography results. All patients who are smear-positive by at least one sample will be diagnosed with TB per national guidelines. Patients who are smear-negative or suspected of extra-pulmonary TB based on clinical or radiographic findings may be treated empirically for TB at the discretion of a clinical or medical officer. Sputum samples will also be sent for testing at the end of the study with the Xpert MTB/RIF assay.	Enrollment screening visit
Secondary	Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.	To account for patients who are censored prior to 12 months of follow-up, the incidence of TB will be calculated as a rate. Each patient will contribute follow-up time until they are censored, are diagnosed with TB, or have been in the study for 12 months. Patients who were diagnosed with TB at enrollment will not be included.	enrollment, 3, 6, 9 and 12 month visits.

External Links

•   University of North Carolina website