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

NCT00233168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2014-06-25

No results posted yet for this study

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.

Conditions

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • San Diego State University

    lead OTHER

Principal Investigators

  • Melbourne Hovell · San Diego State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2007-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00233168 on ClinicalTrials.gov