Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004740
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Randomized Study of Interventions to Enhance Adherence to Isoniazid Prevention Therapy for Tuberculosis in Injection Drug Users
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
1998-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHUSM-93090801 | None | None | None |