Clinical trial NCT00071500: An Electronic Pillbox for People With HIV
Official title: A Novel Technology to Improve HIV Medication Compliance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: Compliance
Adherence
Computerized
Electronic Pillbox
Treatment Experienced
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2003-10-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Medsignals performance
timeFrame: Throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: LIFETECHniques, Inc.
state: California
Study officials:
affiliation: Chairman
name: Vesta Brue, MBA
role: PRINCIPAL_INVESTIGATOR
References: