Behavioral Interventions for Control of TB
Behavioral Interventions for Control of Tuberculosis
To compare alternative methods to ensure completion of treatment and preventive therapy for tuberculosis (TB) in inner cities, and to identify the most cost-effective methods to accomplish that. The basis for comparison included adherence rates and cost savings as primary outcomes, and other parameters such as patient satisfaction, development of social networks, and participation in support programs as secondary outcomes.
Two clinical trials were conducted with patients from Harlem. Among those with active disease, a clinic-based surrogate family model was compared to traditional community-based directly observed therapy (DOT). Among those eligible for preventive therapy, a community-based intervention conducted by trained graduates of a TB DOT program (peer workers) was compared to traditional self-administered preventive treatment.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Tuberculosis was on the decline from the mid 1950s until the mid 1980s; however, the United States is now experiencing a resurgence of tuberculosis. In 1992, approximately 27,000 new cases were reported, an increase of about 20 percent from 1985 to 1992. Not only are tuberculosis cases on the increase, but a serious aspect of the problem is the recent occurence of outbreaks of multidrug resistant (MDR) tuberculosis, which poses an urgent public health problem and requires rapid intervention.
Control programs involve two major components. First, and of highest priority, is to detect persons with active tuberculosis and treat them with effective antituberculosis drugs, which prevents death from tuberculosis and stops the transmission of infection to other persons. Treatment of active tuberculosis involves taking multiple antituberculosis drugs daily or several times weekly for at least six months. Failure to take the medications for the full treatment period may mean that the disease is not cured and may recur. If sufficient medications are not prescribed early and taken regularly, the tuberculosis organism can become resistant to the drugs, and the drug resistant tuberculosis then may be transmitted to other persons. Drug resistant disease is difficult and expensive to treat, and in some cases, cannot be treated with available medications.
The second major goal of control efforts is the detection and treatment of persons who do not have active tuberculosis, but who have latent tuberculosis infection. These people may be at high risk of developing active tuberculosis. The only approved treatment modality for preventive therapy requires treatment daily or twice weekly for a minimum of six months, and many patients do not complete the full course of therapy. Public and patient programs are needed to increase the awareness of the problems associated with tuberculosis control.
The study is part of the NHLBI initiative "Behavioral Interventions for Control of Tuberculosis" . The concept for the initiative originated from the National Institutes of Health Working Group on Health and Behavior. The Request for Applications was released in October, 1994.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
New York
-
New York, New York, Vereinigte Staaten, 10023
- Columbia University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
-Patients with suspected and confirmed TB
Exclusion Criteria:
-Patients that are not a part of the therapy program established at Harlem Hospital, New York City
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Fallkontrolle
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Community-based therapy (case)
Community-based directly observed therapy (DOT) - A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
|
A community-based intervention conducted by trained graduates of a TB directly observed therapy (DOT) program (peer workers)
Andere Namen:
|
|
Self-administered treatment (control)
Clinic directly observed therapy (DOT) - Traditional self-administered preventive treatment
|
A traditional self-administered preventive treatment
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Visit adherence rate
Zeitfenster: At the end of study
|
Prevalence of suspected and confirmed tuberculosis patients that continued treatment
|
At the end of study
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Treatment completion rate
Zeitfenster: At end of study
|
Prevalence of suspected and confirmed tuberculosis patients that completed treatment
|
At end of study
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Wafaa El-Sadr, MD, University Professor; Director, ICAP, Department of Epidemiology
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CUMC ID unknown (4948)
- R01HL055751 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Studiendaten/Dokumente
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Lungenkrankheit
-
Hal C CharlesAbgeschlossenKonstriktive Bronchiolitis | Irak-Afganistan War Lung Injury SyndromeVereinigte Staaten
-
Joseph MccuneEunice Kennedy Shriver National Institute of Child Health and Human Development... und andere MitarbeiterBeendetLupus erythematodes, systemisch | Systemische Vaskulitis | Lungenerkrankung mit systemischer Sklerose | Isolierte Angiitis des zentralen Nervensystems | Lung Disease Interstitial DiffusVereinigte Staaten
Klinische Studien zur Community-based directly observed therapy (DOT)
-
Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)RekrutierungLatente TuberkuloseVereinigte Staaten