Tuberculosis in a Multiethnic Inner City Population

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00005379
First received: May 25, 2000
Last updated: December 28, 2015
Last verified: December 2015
  Purpose
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.

Condition
Acquired Immunodeficiency Syndrome
HIV Infections
Lung Diseases
Tuberculosis
Mycobacterium Tuberculosis

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Tuberculosis in a Multiethnic Inner City Population

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Study Start Date: August 1994
Study Completion Date: July 1999
Primary Completion Date: July 1999 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria
No eligibility criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005379

Sponsors and Collaborators
New York University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Michael Marmor NYU Langone Medical Center
  More Information

Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00005379     History of Changes
Other Study ID Numbers: 4283  R01HL051517 
Study First Received: May 25, 2000
Last Updated: December 28, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Tuberculosis
Lung Diseases
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 25, 2016