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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00233168
First received: October 3, 2005
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

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 Intervention
Lung Diseases
Tuberculosis
Behavioral: Adherence Program
Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Adherence to TB Regimens in High Risk Youth

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Adherence to an INH treatment regimen [ Time Frame: Measured every 30 days for 12 months ] [ Designated as safety issue: No ]
  • Participant recall [ Time Frame: Measured every 30 days for 12 months ] [ Designated as safety issue: No ]
  • Testing of urine for INH metabolites [ Time Frame: Measured every 30 days for 12 months ] [ Designated as safety issue: No ]
  • Pill counts [ Time Frame: Measured every 30 days for 12 months ] [ Designated as safety issue: No ]
  • MEMS caps [ Time Frame: Measured every 30 days for 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parent knowledge and practice of intervention support procedures [ Time Frame: Measured pre-and post intervention (12 months apart) ] [ Designated as safety issue: No ]
  • Parent knowledge of TB [ Time Frame: Measured pre-and post intervention (12 months apart) ] [ Designated as safety issue: No ]
  • Self-esteem effects and life skills acquisition [ Time Frame: Measured pre-and post intervention (12 months apart) ] [ Designated as safety issue: No ]
  • Cost and cost effectiveness of intervention [ Time Frame: Measured every 30 days for 12 months ] [ Designated as safety issue: No ]
  • Knowledge and practice of LTBI care by providers at participating community clinics [ Time Frame: Measured pre and post-test for medical CEU sessions and one-time chart review per participant following treatment completion ] [ Designated as safety issue: No ]

Enrollment: 263
Study Start Date: September 2003
Estimated Study Completion Date: August 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233168

Locations
United States, California
San Diego State University
San Diego, California, United States, 92123
Sponsors and Collaborators
Investigators
Study Chair: Melbourne Hovell San Diego State University
  More Information

No publications provided

Responsible Party: Melbourne F. Hovell, Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University
ClinicalTrials.gov Identifier: NCT00233168     History of Changes
Other Study ID Numbers: 323, R01 HL068595
Study First Received: October 3, 2005
Last Updated: February 11, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 17, 2014