Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 2:25 AM
Study NCT ID:
NCT00233168
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2005-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
Sponsor:
San Diego State University
Organization:
Study Overview
Official Title:
Promoting Adherence to TB Regimens in High Risk Youth
Status:
COMPLETED
Status Verified Date:
2014-06
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:
This study will determine the differential cumulative mean number of isoniazid (INH) pills completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1) peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2) self-esteem/life skills counseling alone. The study will also estimate the costs and cost effectiveness of peer adherence coaching versus control procedures; this will be done from a provider and societal perspective.
Detailed Description:
BACKGROUND:
Tuberculosis (TB) was responsible for almost one billion deaths in the 20th century. It is epidemic in the developing world and immigrants introduce TB to developed nations. TB control requires treatment for latent TB infection (LTBI) and active disease, as well as adherence to medical regimens. This study will determine the effectiveness of a public health model of LTBI control among high-risk adolescents. The integration of behavioral science, medical services, parent instruction, and assistance from schools and clinics (coordinated by the county health department) is based on recommendations from the Centers for Disease Control and Prevention (CDC). The effectiveness of this system is dependent, in part, on patient adherence.
DESIGN NARRATIVE:
The primary outcome of this study is adherence to an INH treatment regimen. For a given participant, adherence is assessed every 30 days, with the final outcome determined 12 months after treatment start date. Adherence is assessed using participant recall, urine testing for INH metabolites, pill counts, and medication event monitoring system (MEMS) caps.
The key secondary outcomes are parent knowledge and practice of intervention support procedures, parent knowledge of TB, self-esteem effects and life skills acquisition, cost and cost effectiveness of the intervention, and knowledge and practice of LTBI care by providers at participating community clinics.
Tuberculosis (TB) was responsible for almost one billion deaths in the 20th century. It is epidemic in the developing world and immigrants introduce TB to developed nations. TB control requires treatment for latent TB infection (LTBI) and active disease, as well as adherence to medical regimens. This study will determine the effectiveness of a public health model of LTBI control among high-risk adolescents. The integration of behavioral science, medical services, parent instruction, and assistance from schools and clinics (coordinated by the county health department) is based on recommendations from the Centers for Disease Control and Prevention (CDC). The effectiveness of this system is dependent, in part, on patient adherence.
DESIGN NARRATIVE:
The primary outcome of this study is adherence to an INH treatment regimen. For a given participant, adherence is assessed every 30 days, with the final outcome determined 12 months after treatment start date. Adherence is assessed using participant recall, urine testing for INH metabolites, pill counts, and medication event monitoring system (MEMS) caps.
The key secondary outcomes are parent knowledge and practice of intervention support procedures, parent knowledge of TB, self-esteem effects and life skills acquisition, cost and cost effectiveness of the intervention, and knowledge and practice of LTBI care by providers at participating community clinics.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL068595 | NIH | None | https://reporter.nih.gov/quic… | View |