Tuberculosis Clinical Trial
Verified date | January 1998 |
Source | Office of Rare Diseases (ORD) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) | Johns Hopkins University |
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