NCT00071500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

3.7 years

First QC Date

October 24, 2003

Last Update Submit

September 25, 2008

Conditions

Keywords

ComplianceAdherenceComputerizedElectronic PillboxTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Medsignals performance

    Throughout study

Study Arms (3)

1

EXPERIMENTAL

Participants will use MedSignals with all of its features

Device: MedSignals™

2

EXPERIMENTAL

Participants will use MedSignals with only alarm features

Device: MedSignals™

3

NO INTERVENTION

Participants will not use any device

Interventions

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.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LIFETECHniques, Inc.

Santa Barbara, California, 93101, United States

Location

MeSH Terms

Conditions

HIV InfectionsPatient Compliance

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Vesta Brue, MBA

    Chairman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 24, 2003

First Posted

October 28, 2003

Study Start

October 1, 2003

Primary Completion

June 1, 2007

Study Completion

June 1, 2009

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations