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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Behavior Blood-Borne Infections Communicable Diseases Genital Diseases Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electronic Medication Reminder System

Device

Medication Manager

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

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

Important dates

Study completion: 2003
First posted: Aug 31, 2001
Registry last updated: Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed