Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00053443
First received: January 29, 2003
Last updated: December 22, 2005
Last verified: December 2005

January 29, 2003
December 22, 2005
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Complete list of historical versions of study NCT00053443 on ClinicalTrials.gov Archive Site
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Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens
Compliance Enhancement In HIV/AIDS Patients

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
HIV Infections
Device: Medication Reminder System/Adherence Tracker
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
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Inclusion Criteria

  • HIV positive
  • Currently taking medications for HIV/AIDS.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053443
2R44AI43750-02 A 2, 5R44AI043750-03
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National Institute of Allergy and Infectious Diseases (NIAID)
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National Institute of Allergy and Infectious Diseases (NIAID)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP