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Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00051766
First Posted: January 17, 2003
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
The purpose of this study is to evaluate the effectiveness of a computer-assisted, self-administered adherence program for patients on complicated anti-HIV drug regimens.

Condition Intervention
Acquired Immunodeficiency Syndrome HIV Infections Behavioral: Computer-based Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: A Computer-Based HIV Medication Adherence Intervention

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 200
Detailed Description:

Highly active antiretroviral therapy (HAART) for HIV produces dramatic reductions in morbidity and mortality for many patients who maintain a high level of adherence to their medications. However, 20% to 33% of HIV infected patients will miss at least one of their medication doses over a one to three day period. Patient self-report is the most practical method for assessing adherence, but it may produce unreliable and invalid results unless optimally performed. A computer-assisted, self-administered adherence program could improve HIV infected patients’ adherence behaviors by accurately and efficiently assessing their medication adherence, delivering an adherence intervention to patients, and producing adherence reports for providers. By providing a neutral and seemingly private interview, computer programs may increase patient disclosure of non-adherence. This study will evaluate the efficacy of a computer-assisted, self-administered adherence program in reducing regimen misunderstandings and enhancing patient adherence.

Participants in this study will be recruited from within the Positive Health Program at San Francisco General Hospital. Patients will be randomly assigned to a Control or Intervention Group. Control Group participants will complete an audio computer-assisted self-interview (A-CASI) assessing their understanding of their medication regimen and adherence. Intervention Group participants will complete the adherence A-CASI and will receive a brief computer-delivered intervention consisting of a graphical depiction of their correct regimen and strategies for improving adherence. Study investigators will forward a computer-generated adherence report, which summarizes their adherence and suggests appropriate interventions, to the Intervention Group’s health care providers. All participants will be assessed at least three times over a 6-month period: study entry, Month 3, and Month 6.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Receiving HIV care at San Francisco General Hospital’s Positive Health Program
  • Three or more antiretroviral medications
  • HIV-1 viral load > 500 copies/ml
  • At least one previous salvage regimen
  • Ability to read English at 8th grade level

Exclusion Criteria

  • Visual impairments that prevent patient from reading text on a computer screen
  • Obvious cognitive impairment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051766


Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Frederick M. Hecht, MD San Francisco General Hospital
Study Director: Amy B. Bronstone, PhD West Portal Software Corporation
Principal Investigator: Roger Hofmann, BS West Portal Software Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00051766     History of Changes
Other Study ID Numbers: 2R44AI044558-02A1 ( U.S. NIH Grant/Contract )
First Submitted: January 16, 2003
First Posted: January 17, 2003
Last Update Posted: December 9, 2005
Last Verified: May 2005

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
compliance
medication
antiretroviral
adherence
intervention
treatment experienced

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