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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00051766 |
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 | Intervention |
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Acquired Immunodeficiency Syndrome HIV Infections |
Behavioral: Computer-based Intervention |
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 |
Estimated 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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, California | |
San Francisco General Hospital | |
San Francisco, California, United States, 94110 |
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 |
Study ID Numbers: | 2R44AI44558-02A1 |
Study First Received: | January 16, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00051766 History of Changes |
Health Authority: | United States: Federal Government |
compliance medication antiretroviral |
adherence intervention treatment experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Anti-HIV Agents HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Disease Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Virus Diseases Pathologic Processes HIV Infections Syndrome Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |