Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
Promoting Adherence to TB Regimens in High Risk Youth
2 other identifiers
interventional
263
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJune 25, 2014
June 1, 2014
3.9 years
October 3, 2005
June 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of INH pills taken
30-day recall of INH consumption measured monthly for up to 12 months
12 months
Study Arms (2)
1
EXPERIMENTALPeer medication adherence counseling
2
ACTIVE COMPARATORPeer life skills counseling
Interventions
14 counseling sessions focusing on INH adherence conducted over 6 months, starting once per week and decreasing in frequency to once a month.
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
You may qualify if:
- 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
You may not qualify if:
- Receiving treatment in Mexico (due to differing medications and length of treatment)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Diego State University
San Diego, California, 92123, United States
Related Publications (7)
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.
PMID: 23710357RESULTWest 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.
PMID: 23439845RESULTWest 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.
PMID: 19936923RESULTWest 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.
PMID: 21409705RESULTHill 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.
PMID: 19085104RESULTSchmitz 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.
PMID: 20435784RESULTHovell 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.
PMID: 30456327DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Melbourne Hovell
San Diego State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director/Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 5, 2005
Study Start
September 1, 2003
Primary Completion
August 1, 2007
Study Completion
August 1, 2008
Last Updated
June 25, 2014
Record last verified: 2014-06