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An Electronic Pillbox for People With HIV

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MedSignals™
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Compliance, Adherence, Computerized, Electronic Pillbox, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LIFETECHniques, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

Participants will use MedSignals with all of its features

Participants will use MedSignals with only alarm features

Participants will not use any device

Outcomes

Primary Outcome Measures

Medsignals performance

Secondary Outcome Measures

Full Information

First Posted
October 24, 2003
Last Updated
September 25, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00071500
Brief Title
An Electronic Pillbox for People With HIV
Official Title
A Novel Technology to Improve HIV Medication Compliance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Compliance, Adherence, Computerized, Electronic Pillbox, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will use MedSignals with all of its features
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will use MedSignals with only alarm features
Arm Title
3
Arm Type
No Intervention
Arm Description
Participants will not use any device
Intervention Type
Device
Intervention Name(s)
MedSignals™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medsignals performance
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vesta Brue, MBA
Organizational Affiliation
Chairman
Official's Role
Principal Investigator
Facility Information:
Facility Name
LIFETECHniques, Inc.
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93101
Country
United States

12. IPD Sharing Statement

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An Electronic Pillbox for People With HIV

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