Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
Primary Purpose
Lung Diseases, Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adherence Program
Life Skills and Self-Esteem Training Program (Attention Control Arm)
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases
Eligibility Criteria
Inclusion Criteria: PPD positive 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: Receiving treatment in Mexico (due to differing medications and length of treatment)
Sites / Locations
- San Diego State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Peer medication adherence counseling
Peer life skills counseling
Outcomes
Primary Outcome Measures
Number of INH pills taken
30-day recall of INH consumption measured monthly for up to 12 months
Secondary Outcome Measures
Full Information
NCT ID
NCT00233168
First Posted
October 3, 2005
Last Updated
June 24, 2014
Sponsor
San Diego State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00233168
Brief Title
Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
Official Title
Promoting Adherence to TB Regimens in High Risk Youth
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Tuberculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
263 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Peer medication adherence counseling
Arm Title
2
Arm Type
Active Comparator
Arm Description
Peer life skills counseling
Intervention Type
Behavioral
Intervention Name(s)
Adherence Program
Intervention Description
14 counseling sessions focusing on INH adherence conducted over 6 months, starting once per week and decreasing in frequency to once a month.
Intervention Type
Behavioral
Intervention Name(s)
Life Skills and Self-Esteem Training Program (Attention Control Arm)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of INH pills taken
Description
30-day recall of INH consumption measured monthly for up to 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PPD positive
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:
Receiving treatment in Mexico (due to differing medications and length of treatment)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melbourne Hovell
Organizational Affiliation
San Diego State University
Official's Role
Study Chair
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23710357
Citation
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.
Results Reference
result
PubMed Identifier
23439845
Citation
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.
Results Reference
result
PubMed Identifier
19936923
Citation
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.
Results Reference
result
PubMed Identifier
21409705
Citation
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.
Results Reference
result
PubMed Identifier
19085104
Citation
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.
Results Reference
result
PubMed Identifier
20435784
Citation
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.
Results Reference
result
PubMed Identifier
30456327
Citation
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.
Results Reference
derived
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Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
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