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Home > "C" Clinical Trials Conditions > Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs  Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
For Condition: Acquired Immunodeficiency Syndrome,HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
AmyBronstone, Study Director, West Portal Software Corporation
San Francisco General Hospital
San Francisco, California, 94110
United States
Frederick Hecht 415-476-4082
Additional Information:
Study ID Numbers: 2R44AI44558-02A1;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051766
Other Acquired Immunodeficiency Syndrome Studies:
1. The Effects of AZT and Ibuprofen on HIV-Infected Patients with Hemophilia
2. A simplified Kaletra® (lopinavir/ritonavir)-based therapy versus a Sustiva® (efavirenz)-based standard of care in previously non-treated HIV-infected subjects
3. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants
4. A Study of ddC in Patients with AIDS or Advanced AIDS-Related Complex (ARC) Who Have Not Had Success with Zidovudine (AZT)
5. An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients
Related Studies:
Other Acquired Immunodeficiency Syndrome Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
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