Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
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|ClinicalTrials.gov Identifier: NCT00233168|
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : June 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lung Diseases Tuberculosis||Behavioral: Adherence Program Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm)||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||263 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Promoting Adherence to TB Regimens in High Risk Youth|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2008|
Peer medication adherence counseling
Behavioral: Adherence Program
14 counseling sessions focusing on INH adherence conducted over 6 months, starting once per week and decreasing in frequency to once a month.
Active Comparator: 2
Peer life skills counseling
Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm)
Peer counseling session covering life skills (e.g., communication skills, goal setting, self-esteem) training, 14 sessions over 6 months beginning once per week and decreasing in frequency over time to once per month.
- Number of INH pills taken [ Time Frame: 12 months ]30-day recall of INH consumption measured monthly for up to 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233168
|United States, California|
|San Diego State University|
|San Diego, California, United States, 92123|
|Study Chair:||Melbourne Hovell||San Diego State University|