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

Study Overview
=================
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.

Official Title
-----------------
Promoting Adherence to TB Regimens in High Risk Youth

Conditions
-----------------
Lung Diseases, Tuberculosis

Intervention / Treatment
-----------------
* Behavioral: Adherence Program
* Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm)


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Peer medication adherence counseling | Behavioral: Adherence Program<br>* 14 counseling sessions focusing on INH adherence conducted over 6 months, starting once per week and decreasing in frequency to once a month.<br>|
| Active Comparator: 2<br>Peer life skills counseling | Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of INH pills taken | 30-day recall of INH consumption measured monthly for up to 12 months | 12 months |