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Completed

NCT Number: NCT02043067

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

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).

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kalingalinga HIV Care and Treatment Clinic

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive TB screening

Other

All enrollees will receive a comprehensive TB screening regardless of symptom presentation.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 23, 2014
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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