Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053443
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2003-01-29
Brief Title:
Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Compliance Enhancement In HIVAIDS Patients
Status:
COMPLETED
Status Verified Date:
2005-12
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:
While anti-HIV drugs can significantly reduce viral loads the medication regimens can be complex and patients must take them correctly for the best effect Nonadherent patients risk developing drug resistant HIV strains The purpose of this study is to evaluate the effectiveness of a handheld computerized system designed to help patients take their drugs correctly
Detailed Description:
As the use of protease inhibitors and other antiretroviral medications has increased multiple drug resistant HIV strains have emerged demonstrating the need for improved patient adherence to complex drug regimens Individual computerized adherence systems have been proposed as a mechanism for improving patient adherence This study will utilize advanced computer and communication technologies to produce a handheld PDA product for HIVAIDS patients The system serves as a patient reminder system addresses problems of missed medications and monitors severity of side effects This study will evaluate the efficacy of the system as an adherence intervention
Participants in the study will be randomized to either the intervention or a control group Participants will use the PDA daily for medication reminders alarms adherence tracking and as a source of information on HIVAIDS The study will last 15 weeks Each participant will have 6 study interviews and 2 quality control interviews Study interviews will include adherence questionnaires blood tests for viral load and CD4 data and quality of life assessments
Participants in the study will be randomized to either the intervention or a control group Participants will use the PDA daily for medication reminders alarms adherence tracking and as a source of information on HIVAIDS The study will last 15 weeks Each participant will have 6 study interviews and 2 quality control interviews Study interviews will include adherence questionnaires blood tests for viral load and CD4 data and quality of life assessments
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R44AI043750-03 | NIH | None | httpsreporternihgovquickSearch5R44AI043750-03 |