An Electronic Pillbox for People With HIV

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00071500
First received: October 24, 2003
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
HIV Infections
Device: MedSignals™
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: A Novel Technology to Improve HIV Medication Compliance

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Medsignals performance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: October 2003
Estimated Study Completion Date: June 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00071500

Locations
United States, California
LIFETECHniques, Inc.
Santa Barbara, California, United States, 93101
Sponsors and Collaborators
Investigators
Principal Investigator: Vesta Brue, MBA Chairman
  More Information

No publications provided

Responsible Party: Vesta Brue, MBA, Medsignals
ClinicalTrials.gov Identifier: NCT00071500     History of Changes
Other Study ID Numbers: 1R43AI52634-01, 1 R43 AI52634-01
Study First Received: October 24, 2003
Last Updated: September 25, 2008
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 28, 2014