Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
OBSERVATIONAL
1994-08-31
1999-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IV drug users and their sexual contacts
This group will be made up of an already-recruited cohort
No interventions assigned to this group
Children who receive primary care at Bellevue Hospital
No interventions assigned to this group
Bellevue Hospital inpatients/outpatients
Inpatients being treated for TB and outpatients receiving prophylactic treatment
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Marmor
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Medical Center
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4283
Identifier Type: -
Identifier Source: org_study_id