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Ensayos clínicos

Ensayos clínicos

A Study on Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00001129, CPCRA 062
  • Concluido

Propósito del estudio

To evaluate the effects of two adherence interventions, a medication manager and an electronic medication reminder system, on the durability of suppression of HIV RNA level among antiretroviral (AR)-naive patients enrolling in the FIRST (Flexible Initial Retrovirus Suppressive Therapies) study (CPCRA 058) and AR-experienced patients enrolling in the PIP (Protease Inhibitor Progression) study (CPCRA 057).

Afección:
Infecciones por el VIH

Detalles del estudio

Adherence to AR therapy has become increasingly important in the management of HIV infection. Adherence to AR regimens is thought to be a critical factor in maintaining therapeutic drug levels, thus helping ensure viral suppression and minimizing the risk of drug resistance. However, AR regimens are often complex with demanding dosing schedules. Patients often miss doses because they simply forget; other factors such as substance abuse, depression, and low literacy levels also contribute to nonadherence. Adherence is influenced not only by individual behavior but also by the services, the quality of the patient-provider relationship, and the amount of social support offered the patient. There is no currently agreed upon, widely used, and generalizable intervention for improving adherence over the long course of HIV therapy. This study provides a long-term comparative evaluation of two interventions.Clinical sites, rather than individual patients, are randomized to one of four groups: a medication manager, an electronic medication reminder system, a medication manager plus an electronic medication reminder system, or usual care. Special training sessions are held for the staff of participating units assigned to medication manager and/or electronic medication reminder system interventions. The medication manager is a research staff member who works individually with study patients, addressing the knowledge, motivation, and skills necessary for adherence. The electronic medication reminder system is ALR (A Little Reminder). This is a small, portable alarm that is programmed to sound and flash at the times of the patient's scheduled AR medication doses. Patients enrolling into either the FIRST or PIP study at clinical sites authorized to carry out this study are offered the option of participating in the adherence intervention to which the clinical site has been randomly assigned. Data collected through the FIRST and the PIP protocols are used to address the Adherence study objectives. Patients on the FIRST protocol are assessed for time to first virologic failure (confirmed rise in viral load above 2,000 copies/ml). Also, patients on the FIRST and PIP studies are assessed for changes in viral load, resistance, CD4 cell counts, adherence, and other factors.

Criterios de exclusión

    Patients will not be eligible for this study if they: Are enrolling at a clinic site that is unable to participate in this study for some reason.

Centros de estudio/contactos

California

    Community Consortium / UCSF, San Francisco, California, 94110, United States

    Virginia Cafaro M.D., San Francisco, California, 94110, United States

Colorado

    Denver CPCRA / Denver Public Hlth, Denver, Colorado, 80204, United States

    Univ Hosp Infectious Diseases Clinic, Denver, Colorado, 80204, United States

Connecticut

    Yale Univ School of Medicine / AIDS Program, New Haven, Connecticut, 06510, United States

District of Columbia

    Washington Reg AIDS Prog / Dept of Infect Dis, Washington, District of Columbia, 20422, United States

Georgia

    AIDS Research Consortium of Atlanta, Atlanta, Georgia, 30308, United States

Illinois

    AIDS Research Alliance - Chicago, Chicago, Illinois, 60657, United States

Louisiana

    Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana, 70112, United States

Michigan

    Henry Ford Hosp, Detroit, Michigan, 48202, United States

    Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit, Michigan, 48201, United States

New Jersey

    Southern New Jersey AIDS Clinical Trials, Camden, New Jersey, 08103, United States

    North Jersey Community Research Initiative, Newark, New Jersey, 07103, United States

New Mexico

    Partners in Research / New Mexico, Albuquerque, New Mexico, 87131, United States

New York

    Bronx-Lebanon Hosp Ctr, Bronx, New York, 10453, United States

    Harlem AIDS Treatment Grp / Harlem Hosp Ctr, New York, New York, 10037, United States

Oregon

    The Research and Education Group, Portland, Oregon, 97210, United States

Pennsylvania

    Philadelphia FIGHT, Philadelphia, Pennsylvania, 19107, United States

Texas

    Univ TX Health Science Ctr, Houston, Texas, 77030, United States

Virginia

    Richmond AIDS Consortium / Div of Infect Diseases, Richmond, Virginia, 23298, United States

Actualizado: 13 de octubre del 2004

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