Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents

Tuberculosis Clinical Trial

Official title:

Promoting Adherence to TB Regimens in High Risk Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233168
• Other study ID #: 323
• Secondary ID: R01HL068595
• Status: Completed
• Phase: N/A
• First received: October 3, 2005
• Last updated: June 24, 2014
• Start date: September 2003
• Est. completion date: August 2008

Study information

• Verified date: June 2014
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: August 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Latent Tuberculosis
• Lung Diseases
• Tuberculosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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: 10.1177/105477381 — View 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 — View 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. Epub 2013 Feb 7 — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of INH pills taken	30-day recall of INH consumption measured monthly for up to 12 months	12 months	No