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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233168
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : June 25, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Melbourne Hovell, 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.

Condition or disease Intervention/treatment Phase
Lung Diseases Tuberculosis Behavioral: Adherence Program Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm) Not Applicable

Detailed Description:


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.


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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Adherence to TB Regimens in High Risk Youth
Study Start Date : September 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: 1
Peer medication adherence counseling
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.

Active Comparator: 2
Peer life skills counseling
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.

Primary Outcome Measures :
  1. Number of INH pills taken [ Time Frame: 12 months ]
    30-day recall of INH consumption measured monthly for up to 12 months

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00233168

United States, California
San Diego State University
San Diego, California, United States, 92123
Sponsors and Collaborators
San Diego State University
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Melbourne Hovell San Diego State University

Publications of Results:

Responsible Party: Melbourne Hovell, Professor, Director/Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego State University Identifier: NCT00233168     History of Changes
Other Study ID Numbers: 323
R01HL068595 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Lung Diseases
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Diseases