Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Device: Medication Reminder System/Adherence Tracker
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: Compliance Enhancement In HIV/AIDS Patients

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 156
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • HIV positive
  • Currently taking medications for HIV/AIDS.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053443

Locations
United States, Massachusetts
Inflexxion
Newton, Massachusetts, United States, 02464
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00053443     History of Changes
Other Study ID Numbers: 2R44AI43750-02 A 2, 5R44AI043750-03
Study First Received: January 29, 2003
Last Updated: December 22, 2005
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Adherence
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014