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

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San Diego State University

Status

Completed

Conditions

Tuberculosis
Lung Diseases

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00233168
323
R01HL068595 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

263 patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

263 participants in 2 patient groups

1
Experimental group
Description:
Peer medication adherence counseling
Treatment:
Behavioral: Adherence Program
2
Active Comparator group
Description:
Peer life skills counseling
Treatment:
Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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