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
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections | Device: MedSignals™ | Phase 1 |
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 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 |
Actual Primary Completion Date : | June 2007 |
Estimated Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Participants will use MedSignals with all of its features
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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.
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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
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- Medsignals performance [ Time Frame: Throughout study ]

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

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
United States, California | |
LIFETECHniques, Inc. | |
Santa Barbara, California, United States, 93101 |
Principal Investigator: | Vesta Brue, MBA | Chairman |
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 |