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

This study is not yet open for patient recruitment.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
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 Treatment or Intervention
Acquired Immunodeficiency Syndrome
HIV Infections
 Behavior: Computer-based Intervention

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Official Title: A Computer-Based HIV Medication Adherence Intervention

Further Study Details: 

Expected Total Enrollment:  200

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

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Exclusion Criteria


Location Information

Amy Bronstone, Ph.D.      415-381-4791    bronstn@pacbell.net

California
      San Francisco General Hospital, San Francisco,  California,  94110,  United States
Frederick Hecht, M.D.  415-476-4082  Ext. 431    rhecht@php.ucsf.edu 
Roger Hofmann, B.S.,  Principal Investigator
David Bangsberg, M.D., M.P.H.,  Sub-Investigator
Frederick Hecht, M.D.,  Sub-Investigator

Study chairs or principal investigators

Frederick M Hecht, M.D.,  Study Chair,  San Francisco General Hospital   
Amy B Bronstone, Ph.D.,  Study Director,  West Portal Software Corporation   
Roger Hofmann, B.S.,  Principal Investigator,  West Portal Software Corporation   

More Information

Study ID Numbers:  2R44AI44558-02A1
Record last reviewed:  April 2004
Record first received:  January 16, 2003
ClinicalTrials.gov Identifier:  NCT00051766
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-20
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