Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005740
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
TB Contact Investigation Behavioral Intervention
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:
2002-05
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 develop a behavioral intervention aimed at public health workers who perform tuberculosis contact investigation and designed to enhance the contact investigation process
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 tubercuosis 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
The project based on social learning theory was conducted in several phases First a process evaluation of the current contact investigation process was conducted Results guided the development of a revised contact investigation protocol a software program for notebook computers designed to enhance protocol implementation and a behavioral intervention to educate contact investigators in the use of the protocol and software A formative evaluation of the intervention protocol and software was used to refine the procedures which were then implemented throughout the State of Alabama An impact evaluation was then conducted to assess the effectiveness of the procedures If the impact evaluation results weresatisfactory the behavioral intervention and contact investigation procedures would be developed in a format that could be exported to other areas and settings
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 tubercuosis 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
The project based on social learning theory was conducted in several phases First a process evaluation of the current contact investigation process was conducted Results guided the development of a revised contact investigation protocol a software program for notebook computers designed to enhance protocol implementation and a behavioral intervention to educate contact investigators in the use of the protocol and software A formative evaluation of the intervention protocol and software was used to refine the procedures which were then implemented throughout the State of Alabama An impact evaluation was then conducted to assess the effectiveness of the procedures If the impact evaluation results weresatisfactory the behavioral intervention and contact investigation procedures would be developed in a format that could be exported to other areas and settings
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 |
|---|---|---|---|
| R01HL055752 | NIH | None | httpsreporternihgovquickSearchR01HL055752 |