Tuberculosis in a Multiethnic Inner City Population

HIV Infections Clinical Trial

Official title:

Tuberculosis in a Multiethnic Inner City Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005379
• Other study ID #: 4283
• Secondary ID: R01HL051517
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: December 28, 2015
• Start date: August 1994
• Est. completion date: July 1999

Study information

• Verified date: December 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 1999
• Est. primary completion date: July 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Lung Diseases
• Mycobacterium Tuberculosis
• Tuberculosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (3)

Davidow AL, Alcabes P, Marmor M. The contribution of recently acquired Mycobacterium tuberculosis infection to the New York City tuberculosis epidemic, 1989-1993. Epidemiology. 2000 Jul;11(4):394-401. — View Citation

Davidow AL, Marmor M, Alcabes P. Geographic diversity in tuberculosis trends and directly observed therapy, New York City, 1991 to 1994. Am J Respir Crit Care Med. 1997 Nov;156(5):1495-500. — View Citation

Wolfe H, Marmor M, Maslansky R, Nichols S, Simberkoff M, Des Jarlais D, Moss A. Tuberculosis knowledge among New York City injection drug users. Am J Public Health. 1995 Jul;85(7):985-8. — View Citation