NCT00203853

Brief Summary

It is known successful HIV therapy depends on the patients' ability to take their medicine regularly. This study is designed to find out if an intervention designed to help patients remember to take their medication is effective. The intervention consists of a wristwatch that has an alarm to remind patients when to take their medication, a pillbox and three monthly phone calls by a physician. All these experimental measures are meant to improve the ability of patients to take their medicines.

Trial Health

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Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

2.2 years

First QC Date

September 12, 2005

Last Update Submit

September 4, 2013

Conditions

Keywords

HIVHAARTmedication adherancepillboxwristwatch

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is to determine if the intervention has any effect on adherance with HAART by noting the HIV viral loads of both groups.

Secondary Outcomes (1)

  • To determine if the study's simple and cost effective intervention has a benefit to subjects and if it would stand to benefit other centers that take care of patients with HIV.

Interventions

Eligibility Criteria

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

You may qualify if:

  • patient must have HIV to participate
  • patient must be at least 18 years of age or older
  • must have been on HAART for six weeks
  • must have a working telephone number

You may not qualify if:

  • patient is HIV negative
  • patient is younger than 18 years of age
  • patient has been on HAART for less than 6 weeks
  • if patient does not have a working telephone number, he/she cannot participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jean-Luc Benoit, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations