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

This study has been terminated.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00051766
First received: January 16, 2003
Last updated: June 23, 2005
Last verified: May 2005

January 16, 2003
June 23, 2005
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Complete list of historical versions of study NCT00051766 on ClinicalTrials.gov Archive Site
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Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
A Computer-Based HIV Medication Adherence Intervention

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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
Behavioral: Computer-based Intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
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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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051766
2R44AI44558-02A1
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National Institute of Allergy and Infectious Diseases (NIAID)
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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
National Institute of Allergy and Infectious Diseases (NIAID)
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP