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

Completed

• Conditions: Tuberculosis
• Interventions: Other: Comprehensive TB screening

• Registration Number: NCT02043067
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2012-09
• Study Completion: 2013-05
• Study First Submitted: 2014-01-16
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Status Verified: 2014-12
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
new HIV clinic enrollees	Comprehensive TB screening	All new enrollees to a Lusaka HIV clinic will receive a full TB work-up.

Primary Outcome Measures

Name	Time	Method
Prevalence of undiagnosed TB in those with HIV.	Enrollment screening visit	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.	enrollment, 3, 6, 9 and 12 month visits.	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.

Trial Locations

Locations (1)

Kalingalinga HIV Care and Treatment Clinic; 🇿🇲 Lusaka, Zambia