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

This study has been completed.
Sponsor:
Collaborators:
Centre for Infectious Disease Research in Zambia
Information provided by (Responsible Party):
Stewart Reid, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02043067
First received: January 16, 2014
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Tuberculosis
Other: Comprehensive TB screening

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhanced TB Screening to Determine the Prevalence and Incidence of TB in a Cohort of HIV Clinic Patients in Lusaka, Zambia

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Prevalence of undiagnosed TB in those with HIV. [ Time Frame: Enrollment screening visit ] [ Designated as safety issue: No ]
    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:
  • Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'. [ Time Frame: enrollment, 3, 6, 9 and 12 month visits. ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Performance of diagnostic measures [ Time Frame: Days 1, 2, 3; Months 3, 6 9 and 12 ] [ Designated as safety issue: No ]
    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.

  • Cost-effectiveness of each screening/diagnostic tool. [ Time Frame: Days 1, 2, 3 and months 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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.

  • Clinical outcomes [ Time Frame: up to 12 months post-enrollment ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Additional samples (10 ml blood, and 20 ml urine) will be stored in the specimen repository at the CIDRZ laboratory for future studies. For patients who agree to provide samples for the repository and are diagnosed with TB, isolates from positive cultures (blood, urine, and/or sputum) will also be stored in the repository.


Enrollment: 400
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043067

Locations
Zambia
Kalingalinga HIV Care and Treatment Clinic
Lusaka, Zambia
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Centre for Infectious Disease Research in Zambia
Investigators
Principal Investigator: Stewart Reid, MD CIDRZ; University of North Carolina at Chapel Hill
  More Information

Additional Information:
Publications:

Responsible Party: Stewart Reid, MD, Research Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02043067     History of Changes
Other Study ID Numbers: 12-0416
Study First Received: January 16, 2014
Last Updated: January 20, 2014
Health Authority: Zambia: Ministry of Health
Zambia: Research Ethics Committee

Keywords provided by University of North Carolina, Chapel Hill:
TB
HIV
Extensively resistant TB
Extra pulmonary TB

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 28, 2014