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An Electronic Pillbox for People With HIV

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ClinicalTrials.gov Identifier: NCT00071500
Recruitment Status : Unknown
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2003
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
Anti-HIV drug regimens can be very complicated. This study will evaluate a new electronic pillbox designed to help people take their anti-HIV drugs correctly.

Condition or disease Intervention/treatment Phase
HIV Infections Device: MedSignals™ Phase 1

Detailed Description:

Recent advances in antiretroviral therapy have allowed for almost complete inhibition of viral replication in HIV-infected individuals. Unfortunately, the ability of the virus to rapidly mutate and become resistant to treatments necessitates the administration of multiple medications, in complex dosing schedules, to maintain viral suppression. Although adherence to these complicated treatment regimens is paramount, even the most vigilant persons often have difficulty maintaining these protocols for extended periods of time.

MedSignals™ is an electronic device that was designed to improve medication compliance among HIV patients. It allows convenient storage and transport of antiretroviral medications and functions as an aid to compliance by incorporating reminding alarms at dosing times and usage reporting functions. The system alarms at pill times, records pill-taking, communicates usage data to servers, and displays progress charts on personalized web pages. Four separately-controlled compartments are easily set for number of dosings per day and number of pills at each dosing. Thereafter, all alarms are relative to last lid openings, assuring intake is optimally spaced. Additional menu options can be set to advise when lids are opened, such as "take with food." Lid openings are time-stamped in memory. The cradle is permanently plugged into telephone and electrical lines for uploading of data and recharging, but the pillbox is portable and pocket-sized. Every day, sensors detect a phone line and upload usage data to servers, allowing authorized caregivers or the patient to observe compliance records. This trial will evaluate MedSignals' usability and functionality in increasing medication compliance in people infected with HIV.

Participants will be randomly assigned to one of three study groups; each group will contain 25 participants. One group will use MedSignals with all of its features, one group will use MedSignals with only alarm features, and the final group will not use any device. Participants will have 4 study visits over 9 weeks and one follow-up telephone call after 6 months. Assessments will include demographic and usability questionnaires.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: A Novel Technology to Improve HIV Medication Compliance
Study Start Date : October 2003
Primary Completion Date : June 2007
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Participants will use MedSignals with all of its features
Device: MedSignals™
An electronic device that is used to improve medication compliance among HIV patients. It allows convenient storage and transport of antiretroviral medications and functions as an aid to compliance by incorporating reminding alarms at dosing times and usage reporting functions.
Experimental: 2
Participants will use MedSignals with only alarm features
Device: MedSignals™
An electronic device that is used to improve medication compliance among HIV patients. It allows convenient storage and transport of antiretroviral medications and functions as an aid to compliance by incorporating reminding alarms at dosing times and usage reporting functions.
No Intervention: 3
Participants will not use any device


Outcome Measures

Primary Outcome Measures :
  1. Medsignals performance [ Time Frame: Throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected for at least six months prior to study entry
  • Currently taking at least one and not more than four antiretroviral medications (not including medications for prophylaxis or unrelated disorders)
  • Understand the benefits of antiviral medications in reducing viral load, boosting immune response, and preventing opportunistic infections
  • Desire to take all antiretroviral medication as scheduled
  • Working telephone
  • Ambulatory
  • Good mental health

Exclusion Criteria:

  • Require assistance dispensing or taking medications
  • Require full or part time assistance with the activities of daily living
  • Does not intend to take all anti-HIV medication over the course of the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071500


Locations
United States, California
LIFETECHniques, Inc.
Santa Barbara, California, United States, 93101
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Vesta Brue, MBA Chairman
More Information

Responsible Party: Vesta Brue, MBA, Medsignals
ClinicalTrials.gov Identifier: NCT00071500     History of Changes
Other Study ID Numbers: 1R43AI052634-01 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2003    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: September 2008

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

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