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

Primary Purpose

Acquired Immunodeficiency Syndrome, HIV Infections

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-based Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Acquired Immunodeficiency Syndrome focused on measuring compliance, medication, antiretroviral, adherence, intervention, treatment experienced

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Francisco General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 16, 2003
Last Updated
June 23, 2005
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00051766
Brief Title
Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
Official Title
A Computer-Based HIV Medication Adherence Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, HIV Infections
Keywords
compliance, medication, antiretroviral, adherence, intervention, treatment experienced

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Computer-based Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick M. Hecht, MD
Organizational Affiliation
San Francisco General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amy B. Bronstone, PhD
Organizational Affiliation
West Portal Software Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Roger Hofmann, BS
Organizational Affiliation
West Portal Software Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

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

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