Clinical trial NCT02043067: Enhanced TB Screening to Determine the Prevalence and Incidence of TB in Patients With HIV
Official title: Enhanced TB Screening to Determine the Prevalence and Incidence of TB in a Cohort of HIV Clinic Patients in Lusaka, Zambia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: TB
HIV
Extensively resistant TB
Extra pulmonary TB
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
name: Centers for Disease Control and Prevention
First posted: 2014-01-23
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of undiagnosed TB in those with HIV.
timeFrame: Enrollment screening visit
Secondary outcomes:
measure: Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.
timeFrame: enrollment, 3, 6, 9 and 12 month visits.
Other outcomes:
measure: Performance of diagnostic measures
timeFrame: Days 1, 2, 3; Months 3, 6 9 and 12
measure: Cost-effectiveness of each screening/diagnostic tool.
timeFrame: Days 1, 2, 3 and months 3, 6, 9 and 12
measure: Clinical outcomes
timeFrame: up to 12 months post-enrollment
Locations:
city: Lusaka
country: Zambia
facility: Kalingalinga HIV Care and Treatment Clinic
Study officials:
affiliation: CIDRZ; University of North Carolina at Chapel Hill
name: Stewart Reid, MD
role: PRINCIPAL_INVESTIGATOR
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