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No. 4, 2010

UPDATE FROM THE TB EPIDEMIOLOGIC STUDIES CONSORTIUM

TBESC Task Order 31: Panel Physician Training Visits

A CDC team completed a three-country training tour in August in preparation for a study to compare the effectiveness of the tuberculin skin test (TST) and interferon-gamma release assays (IGRAs) in children applying to immigrate to the United States.  Suzanne Beavers, MD, Dolly Katz, PhD, and Denise Garrett, MD, oversee the Tuberculosis Epidemiologic Studies Consortium (TBESC), which is conducting the study at screening clinics in Ho Chi Minh City, Vietnam; Manila, Philippines; and Juarez, Mexico.

 The study will compare QuantiFERON (QFT) TB Gold In-Tube and TST results by risk factors for TB in children 2–14 years old who are applying for immigration to the United States. If sufficient data are available, it will also compare QFT and TST results in children diagnosed with clinical or culture-confirmed active TB during the screening.

The epidemiology team first visited Cho Ray Hospital in Ho Chi Minh City, Vietnam, where approximately 22,000 people each year are screened for entry into the United States. Epidemiology team members toured the immigrant screening facility in order to better understand patient flow during the entire process. The team also witnessed sputum specimen collection and processing, and TST application and reading. The epidemiology team members gave talks on study procedures, enrollment, informed consent, TST application and reading, and quality assurance (QA). Epidemiology team members demonstrated a mock enrollment, after which the panel physician staff practiced mock enrollments. The epidemiology team was accompanied by Ed Graviss, PhD and Nhang Ha, who certified site staff in correct QFT procedures. Following the 2 1/2 day training, the Ho Chi Minh City Cho Ray Hospital site was ready to begin enrollment.

The epidemiology and lab teams next traveled to Manila, Philippines, where panel physicians screen approximately 40,000 immigrant candidates each year for U.S. entry. Patient flow through the facility was again reviewed with the staff at the site, and the epidemiology team was also provided a tour of the facility. Despite the hundreds of patients arriving at the facility each day, patient flow is quite orderly and well-organized. The site was certified to begin enrollment after completing training.

Last, the team traveled to El Paso, TX, and Juarez, Mexico, to meet with the site staff. Servicios Medicos de la Frontera screens 44,000 immigrant applicants each year for U.S. entry, the most of any panel physician site. The first day of the training was done in El Paso. On the second day, the epidemiology team staff traveled to Juarez to tour the site and laboratory facilities, observe TST placement and reading, and discuss QA procedures with the staff. The epidemiology team was again accompanied by the lab team, who certified the site on correct QFT procedures.

Enrollment is underway at each site and will continue until approximately June 2011. Each site will enroll between 300 and 1,000 children. The epidemiology team is currently planning site monitoring visits to ensure that enrollment and QA procedures are taking place in accordance with the protocol. This study will provide a wealth of data on the use of QFT in pediatric applicants, as well as the correlation between QFT and TST results in children exposed and unexposed to TB in an accompanying family member.

—Reported by Suzanne Beavers, MD
Div of TB Elimination

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