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Randomized Study of Interventions to Enhance Adherence to Isoniazid Prevention Therapy for Tuberculosis in Injection Drug Users

NCT00004740 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2005-06-24

No results posted yet for this study

Summary

OBJECTIVES: I. Recruit 300 injection drug users with positive tuberculin skin tests who are candidates for isoniazid chemoprophylaxis into a trial of several interventions to enhance adherence to preventive therapy.

II. Compare the effectiveness of self-administered isoniazid chemoprophylaxis supplemented with peer education and support groups versus directly observed preventive therapy delivered by a licensed nurse versus self-administered therapy with standard clinic follow-up and education. Outcome measures are adherence to prescribed doses of medication and the proportion of patients who complete therapy.

III. Compare the impact of monetary incentives on therapy adherence by random assignment to immediate vs. deferred financial incentive.

IV. Assess attitudes, knowledge, and beliefs about tuberculosis and preventive therapy in these patients and determine the association of these factors with demographic, social, and clinical characteristics.

V. Assess attitudes and beliefs about tuberculosis susceptibility, seriousness, benefits of preventive therapy, barriers to therapy, and self-efficacy as predictors of health-related behaviors as measured by adherence with therapy, and determine the impact of the assigned interventions on these attitudes and beliefs.

Conditions

Interventions

DRUG

isoniazid

Sponsors & Collaborators

Principal Investigators

  • Richard E. Chaisson · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-02-28

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Entities

Diseases
Companies

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 NCT00004740 on ClinicalTrials.gov