Isoniazid Therapy Adherence Enhancement for Tuberculosis Prevention in Injection Drug Users
isoniazid
Actinomycetales Infections+9
+ Bacterial Infections and Mycoses
+ Bacterial Infections
Prevention Study
Summary
Study start date: February 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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