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

NCT02043067 | Completed

• 1 other identifier: CIDRZ 1226/IRB12-0416
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Tuberculosis

Keywords

TB; HIV; Extensively resistant TB; Extra pulmonary TB

Outcome Measures

Primary Outcomes (1)

• Prevalence of undiagnosed TB in those with HIV.

  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.

  Enrollment screening visit

Secondary Outcomes (1)

• Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.

  enrollment, 3, 6, 9 and 12 month visits.

Other Outcomes (3)

• Performance of diagnostic measures

  Days 1, 2, 3; Months 3, 6 9 and 12

• Cost-effectiveness of each screening/diagnostic tool.

  Days 1, 2, 3 and months 3, 6, 9 and 12

• Clinical outcomes

  up to 12 months post-enrollment

Study Arms (1)

new HIV clinic enrollees

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

Other: Comprehensive TB screening

Interventions

Comprehensive TB screening OTHER

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

new HIV clinic enrollees

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Any condition, including active drug or alcohol use, which in the opinion of the investigators, would interfere with adherence to study requirements

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centre for Infectious Disease Research in Zambia: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Kalingalinga HIV Care and Treatment Clinic

Lusaka, Zambia

Location

Related Publications (27)

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Related Links

• University of North Carolina website

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.

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Stewart Reid, MD

  CIDRZ; University of North Carolina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 23, 2014
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: May 1, 2013
• Last Updated: September 15, 2017

Record last verified: 2014-12

Locations

ZA (1)