Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
History of Changes

October 24, 2003
September 25, 2008
October 2003
June 2007   (final data collection date for primary outcome measure)
Medsignals performance [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00071500 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Electronic Pillbox for People With HIV
A Novel Technology to Improve HIV Medication Compliance

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
HIV Infections
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: 1
    Participants will use MedSignals with all of its features
    Intervention: Device: MedSignals™
  • Experimental: 2
    Participants will use MedSignals with only alarm features
    Intervention: Device: MedSignals™
  • No Intervention: 3
    Participants will not use any device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
June 2009
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00071500
1R43AI52634-01, 1 R43 AI52634-01
Not Provided
Vesta Brue, MBA, Medsignals
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Vesta Brue, MBA Chairman
National Institute of Allergy and Infectious Diseases (NIAID)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP