Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005737
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Tuberculosis Prophylaxis in the Homeless--A Controlled Trial
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-04
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 conduct a three-arm randomized controlled trial of methods to improve adherence to biweekly directly observed prophylaxis DOPT for tuberculosis in homeless adults in San Francisco
Detailed Description:
BACKGROUND
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 27000 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
DESIGN NARRATIVE
Three approaches were compared for improving adherence to biweekly directly observed prophylaxis for tuberculosis in the homeless 5 biweekly money incentive MI for adherence to DOPT 5 value biweekly non-money incentive NMI for adherence to DOPT and 5 biweekly money incentive supplemented by a peer community outreach worker MI PCOW The outreach worker assisted subjects with completion of adherence to DOPT Predictors of adherence to DOPT were examined including sociodemographic psychological and behavioral and environmental factors
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 27000 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
DESIGN NARRATIVE
Three approaches were compared for improving adherence to biweekly directly observed prophylaxis for tuberculosis in the homeless 5 biweekly money incentive MI for adherence to DOPT 5 value biweekly non-money incentive NMI for adherence to DOPT and 5 biweekly money incentive supplemented by a peer community outreach worker MI PCOW The outreach worker assisted subjects with completion of adherence to DOPT Predictors of adherence to DOPT were examined including sociodemographic psychological and behavioral and environmental factors
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL055729 | NIH | None | httpsreporternihgovquickSearchR01HL055729 |