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NCT00001129 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Adherence Strategies Using a Medication Manager and an Electronic Medication Reminder System for HIV-Infected Patients Receiving HAART

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001129
Other study ID # CPCRA 062
Secondary ID 11617
Status Completed
Phase N/A
First received January 17, 2000
Last updated September 28, 2013
Est. completion date June 2003

Study information
Verified date September 2013
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to look at different ways to help patients follow their anti-HIV medication schedules.

It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them. Taking the drugs correctly, called "adherence," may keep HIV virus levels in the blood (viral load) low for a longer time. However, anti-HIV medication schedules are often complicated, and many patients have difficulty remembering to take their drugs at the correct time. This study will look at 2 different ways to teach patients about the importance of taking their medications correctly and to remind them when to take their medications.

Description:

Adherence to antiretroviral (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 MDR-HIV 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 MDR-HIV protocols are used to address the Adherence study objectives. Patients on the FIRST protocol are assessed for time to first plasma HIV-RNA level above 2,000 copies/ml. Also, patients on the FIRST and MDR-HIV studies are assessed for changes in viral load, resistance, CD4 cell counts, adherence, and other factors.

Recruitment information / eligibility
Status Completed
Enrollment 1248
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria

Patients may be eligible for this study if they:

- Are enrolling in a qualifying CPCRA AR therapeutic study. Currently, the FIRST and MDR-HIV studies are the only qualifying protocols.

Exclusion Criteria

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.

Study Design

Intervention Model: Factorial Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Electronic Medication Reminder System

Behavioral:
• Medication Manager

Locations
Country Name City State
United States Partners in Research / New Mexico Albuquerque New Mexico
United States AIDS Research Consortium of Atlanta Atlanta Georgia
United States Bronx-Lebanon Hosp Ctr Bronx New York
United States Southern New Jersey AIDS Clinical Trials Camden New Jersey
United States AIDS Research Alliance - Chicago Chicago Illinois
United States Denver CPCRA / Denver Public Hlth Denver Colorado
United States Univ Hosp Infectious Diseases Clinic Denver Colorado
United States Henry Ford Hosp Detroit Michigan
United States Wayne State Univ - WSU/DMC / Univ Hlth Ctr Detroit Michigan
United States Univ TX Health Science Ctr Houston Texas
United States Yale Univ School of Medicine / AIDS Program New Haven Connecticut
United States Louisiana Comm AIDS Rsch Prog / Tulane Univ Med New Orleans Louisiana
United States Harlem AIDS Treatment Grp / Harlem Hosp Ctr New York New York
United States North Jersey Community Research Initiative Newark New Jersey
United States Philadelphia FIGHT Philadelphia Pennsylvania
United States The Research and Education Group Portland Oregon
United States Richmond AIDS Consortium / Div of Infect Diseases Richmond Virginia
United States Community Consortium / UCSF San Francisco California
United States Virginia Cafaro M.D. San Francisco California
United States Washington Reg AIDS Prog / Dept of Infect Dis Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

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