Tuberculosis
Conditions
Keywords
TB, HIV, Extensively resistant TB, Extra pulmonary TB
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.
Interventions
OTHERComprehensive TB screening
All enrollees will receive a comprehensive TB screening regardless of symptom presentation.
Sponsors
Centre for Infectious Disease Research in Zambia
Centers for Disease Control and Prevention
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Performance of diagnostic measures | 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. |
| Cost-effectiveness of each screening/diagnostic tool. | 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. |
| Clinical outcomes | 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. |
Countries
Zambia
Outcome results
None listed