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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Computer-Based HIV Medication Adherence Intervention

Conditions
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HIV Infections, Acquired Immunodeficiency Syndrome

Intervention / Treatment
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* Behavioral: Computer-based Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Computer-based Intervention|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compliance, medication, antiretroviral, adherence, intervention, treatment experienced