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Evaluation of an Intervention on Adherence to Highly Active Antiretroviral Therapy (HAART) in HIV Infected Adults

This study has been terminated.
Sponsor:
Collaborator:
Ralph and Marion Falk Medical Trust
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00203853
First received: September 12, 2005
Last updated: March 18, 2007
Last verified: March 2007
History of Changes
  Purpose

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.


Condition Intervention
HIV Infections
 Device: pillbox, wristwatch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of an Intervention (Consisting of an Electronic Reminder Device, Pillboxes, and Monthly Telephone Calls) on Adherence to Highly Active Antiretroviral Therapy (HAART) in HIV Infected Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 200
Study Start Date: January 2005
Estimated Study Completion Date: January 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00203853

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Ralph and Marion Falk Medical Trust
Investigators
Principal Investigator: Jean-Luc Benoit, MD University of Chicago
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00203853     History of Changes
Other Study ID Numbers: 13640A, Falk Medical Trust Grant
Study First Received: September 12, 2005
Last Updated: March 18, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
HIV
HAART
medication adherance
pillbox
wristwatch

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013