Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005379
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
2000-05-25
Brief Title:
Tuberculosis in a Multiethnic Inner City Population
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Tuberculosis in a Multiethnic Inner City Population
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL051517 | NIH | None | httpsreporternihgovquickSearchR01HL051517 |