Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005741
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Indigenous Outreach Among Injection Drug Users to Treat and Control TB
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:
The Community Outreach Intervention Project COIP implemented and evaluated a TB intervention with injection drug users IDUs in two Chicago Neighborhoods guided by the indigenous outreach leadership model that had been used for AIDS prevention among drug users
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
Three hypotheses were tested The first was that rates of treatment adherence would be greater among actively infected injection drug users assisted through indigenous outreach than through conventional TB control methods practiced by the Chicago Department of Health The second hypothesis was that rates of compliance with contact tracing screening and treatment wouldl be greater through the COIP intervention than through the practices of the Health Department The third was that community level rates of TB would decrease over the years of the study as a result of the intervention
Enrollment of the cases and contacts for Phase II began in July 1996 The intervention was implemented by a specially trained indigenous outreach staff guided by an experienced ethnographer Quantitative and qualitative methods were used to assess the effects of the intervention on treatment completion attendance compliance with contact and screening efforts knowledge of TB transmission reduction of health risk behavior and rates of TB infection
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
Three hypotheses were tested The first was that rates of treatment adherence would be greater among actively infected injection drug users assisted through indigenous outreach than through conventional TB control methods practiced by the Chicago Department of Health The second hypothesis was that rates of compliance with contact tracing screening and treatment wouldl be greater through the COIP intervention than through the practices of the Health Department The third was that community level rates of TB would decrease over the years of the study as a result of the intervention
Enrollment of the cases and contacts for Phase II began in July 1996 The intervention was implemented by a specially trained indigenous outreach staff guided by an experienced ethnographer Quantitative and qualitative methods were used to assess the effects of the intervention on treatment completion attendance compliance with contact and screening efforts knowledge of TB transmission reduction of health risk behavior and rates of TB infection
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 |
|---|---|---|---|
| R01HL055760 | NIH | None | httpsreporternihgovquickSearchR01HL055760 |