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NCT00053443 Clinical Trial

Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens

HIV Infections Clinical Trial

Official title:
Compliance Enhancement In HIV/AIDS Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00053443
Other study ID # 2R44AI43750-02 A 2
Secondary ID 5R44AI043750-03
Status Completed
Phase Phase 2
First received January 29, 2003
Last updated December 13, 2016
Est. completion date December 2005

Study information
Verified date December 2005
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

While anti-HIV drugs can significantly reduce viral loads, the medication regimens can be complex, and patients must take them correctly for the best effect. Nonadherent patients risk developing drug resistant HIV strains. The purpose of this study is to evaluate the effectiveness of a handheld computerized system designed to help patients take their drugs correctly.

Description:

As the use of protease inhibitors and other antiretroviral medications has increased, multiple drug resistant HIV strains have emerged, demonstrating the need for improved patient adherence to complex drug regimens. Individual computerized adherence systems have been proposed as a mechanism for improving patient adherence. This study will utilize advanced computer and communication technologies to produce a handheld (PDA) product for HIV/AIDS patients. The system serves as a patient reminder system, addresses problems of missed medications, and monitors severity of side effects. This study will evaluate the efficacy of the system as an adherence intervention.

Participants in the study will be randomized to either the intervention or a control group. Participants will use the PDA daily for medication reminders, alarms, adherence tracking, and as a source of information on HIV/AIDS. The study will last 15 weeks. Each participant will have 6 study interviews and 2 quality control interviews. Study interviews will include adherence questionnaires, blood tests for viral load and CD4 data, and quality of life assessments.

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria

- HIV positive

- Currently taking medications for HIV/AIDS.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Medication Reminder System/Adherence Tracker

Locations
Country Name City State
United States Inflexxion Newton Massachusetts

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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