Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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Adherence Treatment Experienced

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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Medication Reminder System/Adherence Tracker

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* HIV positive
* Currently taking medications for HIV/AIDS.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Inflexxion

Newton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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5R44AI043750-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2R44AI43750-02 A 2

Identifier Type: -

Identifier Source: org_study_id