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

NCT ID: NCT00051766

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

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.

Conditions

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Acquired Immunodeficiency Syndrome HIV Infections

Keywords

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compliance medication antiretroviral adherence intervention treatment experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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Computer-based Intervention

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Frederick M. Hecht, MD

Role: STUDY_CHAIR

San Francisco General Hospital

Amy B. Bronstone, PhD

Role: STUDY_DIRECTOR

West Portal Software Corporation

Roger Hofmann, BS

Role: PRINCIPAL_INVESTIGATOR

West Portal Software Corporation

Locations

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San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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2R44AI044558-02A1

Identifier Type: NIH

Identifier Source: org_study_id

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