Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051805
Status:
COMPLETED
Last Update Posted:
2007-09-18
First Post:
2003-01-16
Brief Title:
Promoting 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:
Promoting Adherence to Antiretroviral Regimens
Status:
COMPLETED
Status Verified Date:
2007-08
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:
One of the main causes of treatment failure in HIV infected individuals is lack of adherence to complicated drug regimens The purpose of this study is to evaluate the effectiveness of a behavioral intervention program designed to improve adherence to anti-HIV drug regimens Participants in this study will be recruited from the University of Alabama at Birmingham UAB Outpatient HIV Clinic
Detailed Description:
Poor adherence to complicated antiretroviral ARV drug regimens is one of the most pressing behavioral problems in the clinical management of HIV infected persons Recent medical advances have made it possible to maintain tighter control of viral replication allowing people with HIV to live longer healthier lives However the complexity of ARV drug regimens and drug side effects make medication adherence problematic Deviations from the prescribed regimen may allow the virus to resume rapid replication and develop drug resistant mutations that could render the prescribed drugs useless This study will evaluate the efficacy of a 6-month theory-based behavioral intervention to enhance adherence to antiretroviral treatment regimens HIV-related attitudes depressive symptoms coping strategies and social support will also be assessed to examine theoretical assumptions regarding the causal relationship between psychosocial constructs and medication adherence
Participants in this study will be recruited from UAB Outpatient HIV Clinic patients who are taking ARV medication Participants will be randomized to a Standard Adherence Promotion Group or an Enhanced Adherence Promotion Group The Enhanced Adherence Promotion will systematically address specific psychosocial issues associated with medication adherence Participants will be followed for 6 months and adherence will be evaluated at monthly study visits Pill counts viral loads self-reported adherence to ARV medication CD4 count and genotypic viral resistance will be assessed
Participants in this study will be recruited from UAB Outpatient HIV Clinic patients who are taking ARV medication Participants will be randomized to a Standard Adherence Promotion Group or an Enhanced Adherence Promotion Group The Enhanced Adherence Promotion will systematically address specific psychosocial issues associated with medication adherence Participants will be followed for 6 months and adherence will be evaluated at monthly study visits Pill counts viral loads self-reported adherence to ARV medication CD4 count and genotypic viral resistance will be assessed
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 |
|---|---|---|---|
| 5R01AI045403-03 | NIH | None | httpsreporternihgovquickSearch5R01AI045403-03 |
| 3R01AI045403-02S1 | NIH | None | None |