Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
NCT ID: NCT00233168
Last Updated: 2014-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
263 participants
INTERVENTIONAL
2003-09-30
2008-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Promoting Adherence to TB Regimens in Latino Adolescents
NCT00005738
Behavioral Interventions for Control of Tuberculosis
NCT00005742
Self-verification and Support Via Mobile Phones Drastically Improves Tuberculosis Treatment Success in LMIC Settings
NCT03135366
TB mHealth Study - Use of Cell Phones to Improve Compliance in Patients on LTBI Treatment
NCT01549457
The Effect of Telephone Follow-up and Training on Treatment Adherence in Tuberculosis Patients and Contacts
NCT05202431
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Peer medication adherence counseling
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.
2
Peer life skills counseling
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* San Diego County residents (without plans to relocate out of the county in the 12 months after study entry)
* Able to respond to the interview questions in English or Spanish
* Eligible for INH treatment
Exclusion Criteria
13 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
San Diego State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Melbourne Hovell
Professor, Director/Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Melbourne Hovell
Role: STUDY_CHAIR
San Diego State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Diego State University
San Diego, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hill LL, Hovell M, Blumberg E, Kelley N, Baird S, Sipan C, Schmitz K, Friedman L. Gaps between Adolescent Risk Behaviors and Disclosure during Outpatient Visits. Int J Family Med. 2013;2013:718568. doi: 10.1155/2013/718568. Epub 2013 Apr 24.
West JH, Blumberg EJ, Kelley NJ, Hill L, Sipan CL, Schmitz KE, Kolody B, Chambers CD, Friedman LS, Hovell MF. The Role of Parenting in Alcohol and Tobacco Use Among Latino Adolescents. J Child Adolesc Subst Abuse. 2013 Apr 1;22(2):120-132. doi: 10.1080/1067828X.2012.730359. Epub 2013 Feb 7.
West JH, Blumberg EJ, Kelley NJ, Hill L, Sipan CL, Schmitz KE, Ryan S, Clapp JD, Hovell MF. Does proximity to retailers influence alcohol and tobacco use among Latino adolescents? J Immigr Minor Health. 2010 Oct;12(5):626-33. doi: 10.1007/s10903-009-9303-2.
West JH, Blumberg EJ, Kelley NJ, Hill L, Sipan CL, Schmitz K, Kolody B, Madlensky L, Hovell MF. Latino parenting practices: a comparison of parent and child reports of parenting practices and the association with gateway drug use. J Ethn Subst Abuse. 2011;10(1):71-89. doi: 10.1080/15332640.2011.547800.
Hill L, Blumberg E, Sipan C, Schmitz K, West J, Kelley N, Hovell M. Multi-level barriers to LTBI treatment: a research note. J Immigr Minor Health. 2010 Aug;12(4):544-50. doi: 10.1007/s10903-008-9216-5. Epub 2008 Dec 16.
Schmitz KE, Hovell MF, Wong CA, Kelley NJ, Nilsen D, Blumberg EJ, Hill LL, Sipan CL, Kolody B, Chatfield DA. The reliability and practicality of the Arkansas method assay of isoniazid adherence. Clin Nurs Res. 2010 May;19(2):131-43. doi: 10.1177/1054773810363473.
Hovell MF, Schmitz KE, Blumberg EJ, Hill L, Sipan C, Friedman L. Lessons learned from two interventions designed to increase adherence to LTBI treatment in Latino youth. Contemp Clin Trials Commun. 2018 Aug 16;12:129-136. doi: 10.1016/j.conctc.2018.08.002. eCollection 2018 Dec.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
323
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.