Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001129
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
2000-01-17
Brief Title:
A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Adherence Strategies Using a Medication Manager and an Electronic Medication Reminder System for HIV-Infected Patients Receiving HAART
Status:
COMPLETED
Status Verified Date:
2013-09
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 look at different ways to help patients follow their anti-HIV medication schedules
It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them Taking the drugs correctly called adherence may keep HIV virus levels in the blood viral load low for a longer time However anti-HIV medication schedules are often complicated and many patients have difficulty remembering to take their drugs at the correct time This study will look at 2 different ways to teach patients about the importance of taking their medications correctly and to remind them when to take their medications
It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them Taking the drugs correctly called adherence may keep HIV virus levels in the blood viral load low for a longer time However anti-HIV medication schedules are often complicated and many patients have difficulty remembering to take their drugs at the correct time This study will look at 2 different ways to teach patients about the importance of taking their medications correctly and to remind them when to take their medications
Detailed Description:
Adherence to antiretroviral AR therapy has become increasingly important in the management of HIV infection Adherence to AR regimens is thought to be a critical factor in maintaining therapeutic drug levels thus helping ensure viral suppression and minimizing the risk of drug resistance However AR regimens are often complex with demanding dosing schedules Patients often miss doses because they simply forget other factors such as substance abuse depression and low literacy levels also contribute to nonadherence Adherence is influenced not only by individual behavior but also by the services the quality of the patient-provider relationship and the amount of social support offered the patient There is no currently agreed upon widely used and generalizable intervention for improving adherence over the long course of HIV therapy This study provides a long-term comparative evaluation of two interventions
Clinical sites rather than individual patients are randomized to one of four groups a medication manager an electronic medication reminder system a medication manager plus an electronic medication reminder system or usual care Special training sessions are held for the staff of participating units assigned to medication manager andor electronic medication reminder system interventions The medication manager is a research staff member who works individually with study patients addressing the knowledge motivation and skills necessary for adherence The electronic medication reminder system is ALR A Little Reminder This is a small portable alarm that is programmed to sound and flash at the times of the patients scheduled AR medication doses Patients enrolling into either the FIRST or MDR-HIV study at clinical sites authorized to carry out this study are offered the option of participating in the adherence intervention to which the clinical site has been randomly assigned Data collected through the FIRST and the MDR-HIV protocols are used to address the Adherence study objectives Patients on the FIRST protocol are assessed for time to first plasma HIV-RNA level above 2000 copiesml Also patients on the FIRST and MDR-HIV studies are assessed for changes in viral load resistance CD4 cell counts adherence and other factors
Clinical sites rather than individual patients are randomized to one of four groups a medication manager an electronic medication reminder system a medication manager plus an electronic medication reminder system or usual care Special training sessions are held for the staff of participating units assigned to medication manager andor electronic medication reminder system interventions The medication manager is a research staff member who works individually with study patients addressing the knowledge motivation and skills necessary for adherence The electronic medication reminder system is ALR A Little Reminder This is a small portable alarm that is programmed to sound and flash at the times of the patients scheduled AR medication doses Patients enrolling into either the FIRST or MDR-HIV study at clinical sites authorized to carry out this study are offered the option of participating in the adherence intervention to which the clinical site has been randomly assigned Data collected through the FIRST and the MDR-HIV protocols are used to address the Adherence study objectives Patients on the FIRST protocol are assessed for time to first plasma HIV-RNA level above 2000 copiesml Also patients on the FIRST and MDR-HIV studies are assessed for changes in viral load resistance CD4 cell counts adherence and other factors
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 |
|---|---|---|---|
| 11617 | REGISTRY | DAIDS ES | None |