Tuberculosis in a Multiethnic Inner City Population - Tabular View

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Tuberculosis in a Multiethnic Inner City Population

This study has been completed.

Study NCT00005379. Last updated on June 23, 2005. Information provided by National Heart, Lung, and Blood Institute (NHLBI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Tuberculosis in a Multiethnic Inner City Population
Official Title ^†
Brief Summary	To determine the incidence of tuberculosis in an inner city population, identify risk factors for TB, describe the natural history in adults and children, evaluate the effect of Mycobacterium tuberculosis (Mtb) co-infection on the progression of human immunodeficiency virus disease, and determine factors that contribute to compliance and non-compliance with prophylaxis and treatment.
Detailed Description	BACKGROUND: The research provided urgently needed information regarding incidence, risk factors, natural history, molecular epidemiology, treatment, and prevention of tuberculosis in an especially vulnerable multi-ethnic inner-city population with a high HIV seropositivity rate. The study was part of a collaborative project on minority health, The Epidemiology, Drug Resistance, and Therapy of Tuberculosis in a Multi-Ethnic Inner City Population with a High HIV Seropositivity Rate. The 1993 Report of the Committee on Appropriations, House of Representatives, encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. The concept for the initiative was developed by the NHLBI staff and approved by the September 1992 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in October 1992. DESIGN NARRATIVE: The study was conducted prospectively and retrospectively in three groups of patients: intravenous drug users and their sexual contacts in an already-recruited cohort; children who received their primary care at Bellevue Hospital Medical Center; and Bellevue Hospital Center inpatients with TB and outpatients who underwent prophylactic treatment. In addition to environmental risk factors (e.g., hopelessness, cohabitation with tuberculosis patients and injected drug use), host factors were investigated, including: HIV infection; immune status among HIV- seropositive persons, as indicated by quantitative p24 antibodies; CD4, CD8, and gammadelta T cell counts; and race, age, and nutritional status. Incidence and risk-factors in the cohort were assessed by interview, blood draw, PPD screening, medical record review, and anergy panel. Natural history and impact on HIV disease in adult and pediatric populations were assessed by interviews, clinical screening and laboratory measures. Drug sensitivity testing and RFLP typing of specimens from the two populations were conducted, respectively, at the Bellevue Mycobacteriology Lab and the Public Health Research Institute. Factors affecting treatment compliance were assessed by self-administered questionnaire.
Study Phase
Study Type ^†	Observational
Study Design ^†	Natural History
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Acquired Immunodeficiency Syndrome HIV Infections Lung Diseases Tuberculosis Mycobacterium Tuberculosis
Intervention ^†
MEDLINE PMIDs	7604926, 9372666, 10874545
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†	August 1994
Completion Date	July 1999
Eligibility Criteria ^†	No eligibility criteria
Gender	Male
Ages
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†

Administrative Information Fields
NCT ID ^†	NCT00005379
Organization ID	4283
Secondary IDs ^††
Study Sponsor ^†	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^††
Investigators ^†
Information Provided By	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	April 2002
First Received Date ^†	May 25, 2000
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.