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

Not Applicable

Completed

• Conditions: Lung Diseases; Tuberculosis
• Interventions: Behavioral: Adherence Program; Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm)

• Registration Number: NCT00233168
• Lead Sponsor: San Diego State University

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-05
• Primary Completion: 2007-08
• Study Completion: 2008-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adherence Program	Peer medication adherence counseling
2	Life Skills and Self-Esteem Training Program (Attention Control Arm)	Peer life skills counseling

Primary Outcome Measures

Name	Time	Method
Number of INH pills taken	12 months	30-day recall of INH consumption measured monthly for up to 12 months

Trial Locations

Locations (1)

San Diego State University; 🇺🇸 San Diego, California, United States