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

University of North Carolina (UNC)

Status: Completed

Conditions: Tuberculosis

Treatments: Other: Comprehensive TB screening

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02043067

CIDRZ 1226/IRB12-0416

Details and patient eligibility

About

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).

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 16 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

new HIV clinic enrollees

Description:

All new enrollees to a Lusaka HIV clinic will receive a full TB work-up.

Treatment:

Other: Comprehensive TB screening