Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
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 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 May 21, 2013