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

September 13, 2017 updated by: University of North Carolina, Chapel Hill

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Kalingalinga HIV Care and Treatment Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Four hundred new enrollees at the Kalingalinga HIV Care and Treatment Clinic who are not currently being treated for TB.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
new HIV clinic enrollees
All new enrollees to a Lusaka HIV clinic will receive a full TB work-up.
Other: Comprehensive TB screening
All enrollees will receive a comprehensive TB screening regardless of symptom presentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of undiagnosed TB in those with HIV.
Time Frame: 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.
Enrollment screening visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.
Time Frame: 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.
enrollment, 3, 6, 9 and 12 month visits.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of diagnostic measures
Time Frame: Days 1, 2, 3; Months 3, 6 9 and 12
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
Cost-effectiveness of each screening/diagnostic tool.
Time Frame: Days 1, 2, 3 and months 3, 6, 9 and 12
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
Clinical outcomes
Time Frame: up to 12 months post-enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Centers for Disease Control and Prevention
Centre for Infectious Disease Research in Zambia

Investigators

  • Principal Investigator: Stewart Reid, MD, CIDRZ; University of North Carolina at Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIDRZ 1226/IRB12-0416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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