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

June 23, 2005 updated by: National Institute on Drug Abuse (NIDA)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

PROTOCOL OUTLINE: This is a randomized study. Patients in the first group self-administer oral isoniazid following the standard clinic protocol for 6 months. They receive individual counseling and education by a peer educator at entry and at week 2, participate in a monthly support group cofacilitated by a peer counselor and health educator, and make a monthly clinic visit.

Patients in the second group receive oral isoniazid twice a week. Therapy is administered by the nurse, who observes ingestion and swallowing. Nursing education and support per standard clinic procedures is provided at each monthly clinic visit.

Patients in the third group self-administer oral isoniazid, without enhanced education and peer support, following the standard clinic protocol for 6 months. Nursing education and support per standard clinic procedures is provided at each monthly clinic visit.

Within each group, patients are randomly assigned to an immediate or deferred financial compensation schedule. Immediate compensation for compliance with medication and clinical visit is given during the monthly clinic visit, while deferred compensation is given at study completion.

It is recommended that HIV-seropositive patients receive 6 additional months of standard isoniazid therapy.

Study Type

Interventional

Enrollment

300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

PROTOCOL ENTRY CRITERIA:

Population Characteristics

  • Positive purified protein derivative (PPD) tuberculin skin test, with induration as follows: 10 mm or greater if HIV seronegative 5 mm or greater if HIV seropositive or status unknown
  • No active tuberculosis (TB) on chest x-ray
  • Candidate for isoniazid prophylaxis through Baltimore City Health Department
  • Active or treated injection drug user, i.e.: Injected illicit drugs within the last 3 months OR Previously injected drugs and is in drug treatment
  • Injection use documented by: Subject self report Medical and referral records from drug treatment programs Physical exam for stigmata of injection drug use

Prior/Concurrent Therapy

  • No more than 6 months of prior TB preventive therapy for HIV

Subject Characteristics

  • Hepatic: ALT no greater than 3 x ULN
  • Renal: Not specified
  • Other: No prior serious adverse reaction to isoniazid No requirement for HIV therapy other than Pneumocystis prophylaxis or antiretrovirals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Johns Hopkins University

Investigators

  • Study Chair: Richard E. Chaisson, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1995

Study Registration Dates

First Submitted

February 24, 2000

First Submitted That Met QC Criteria

February 24, 2000

First Posted (ESTIMATE)

February 25, 2000

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

January 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/11642
  • JHUSM-93090801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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