Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051766
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
2003-01-16
Brief Title:
Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Computer-Based HIV Medication Adherence Intervention
Status:
TERMINATED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 Groups health care providers All participants will be assessed at least three times over a 6-month period study entry Month 3 and Month 6
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 Groups health care providers All participants will be assessed at least three times over a 6-month period study entry Month 3 and Month 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None