Tuberculosis in a Multiethnic Inner City Population

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Acquired Immunodeficiency Syndrome; Lung Diseases; Tuberculosis; Mycobacterium Tuberculosis

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be made up of three cohorts: (1) intravenous drug users and their sexual contacts in an already-recruited cohort; (2) children who receive their primary care at Bellevue Hospital Medical Center; and (3) Bellevue Hospital Center inpatients with TB and outpatients undergoing prophylactic treatment

Description

No eligibility criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
IV drug users and their sexual contacts; This group will be made up of an already-recruited cohort
Children who receive primary care at Bellevue Hospital
Bellevue Hospital inpatients/outpatients; Inpatients being treated for TB and outpatients receiving prophylactic treatment

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Michael Marmor, NYU Langone Medical Center

Publications and helpful links

General Publications

• 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. doi: 10.2105/ajph.85.7.985.
• 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. doi: 10.1164/ajrccm.156.5.96-12078.
• 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. doi: 10.1097/00001648-200007000-00006.

Study record dates

Study Major Dates

• Study Start: August 1, 1994
• Primary Completion (Actual): July 1, 1999
• Study Completion (Actual): July 1, 1999

Study Registration Dates

• First Submitted: May 25, 2000
• First Submitted That Met QC Criteria: May 25, 2000
• First Posted (Estimate): May 26, 2000

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Slow Virus Diseases; HIV Infections; Lung Diseases; Tuberculosis; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: 4283; R01HL051517 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No