- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00051766
Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
A Computer-Based HIV Medication Adherence Intervention
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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California
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San Francisco, California, Förenta staterna, 94110
- San Francisco General Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Utbildning/Rådgivning/Träning
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Samarbetspartners och utredare
Utredare
- Studiestol: Frederick M. Hecht, MD, San Francisco General Hospital
- Studierektor: Amy B. Bronstone, PhD, West Portal Software Corporation
- Huvudutredare: Roger Hofmann, BS, West Portal Software Corporation
Studieavstämningsdatum
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Sexuellt överförbara sjukdomar, virala
- Sexuellt överförbara sjukdomar
- Lentivirusinfektioner
- Retroviridae-infektioner
- Immunsystemets sjukdomar
- Långsamma virussjukdomar
- HIV-infektioner
- Förvärvat immunbristsyndrom
- Immunologiska bristsyndrom
Andra studie-ID-nummer
- 2R44AI044558-02A1 (U.S.S. NIH-anslag/kontrakt)
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