Randomized Study of Interventions to Enhance Adherence to Isoniazid Prevention Therapy for Tuberculosis in Injection Drug Users
isoniazid
Infecciones por Actinomicetales+6
+ Infecciones Bacterianas y Micosis
+ Infecciones bacterianas
Estudio de Prevención
Resumen
Fecha de inicio: 1 de febrero de 1995
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 300 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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