Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens - Tabular View

Tracking Information
First Received Date ^ICMJE	January 29, 2003
Last Updated Date	December 22, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00053443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens
Official Title ^ICMJE	Compliance Enhancement In HIV/AIDS Patients
Brief 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.
Detailed 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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Efficacy Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Device: Medication Reminder System/Adherence Tracker
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	156
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria HIV positive Currently taking medications for HIV/AIDS.
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00053443
Responsible Party
Study ID Numbers ^ICMJE	2R44AI43750-02 A 2, 5R44AI043750-03
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	December 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP