Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273780
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2006-01-05
Brief Title:
Highly Active Antiretroviral Therapy HAART Adherence Interventions
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
HAART Adherence Interventions in Africa An RCT
Status:
COMPLETED
Status Verified Date:
2012-08
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:
This study proposes a 4-armed factorial randomized clinical trial in Nairobi Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence
Detailed Description:
The study will be a prospective randomized clinical control trial among HIV-1 seropositive adult participants beginning HAART highly active antiretroviral therapy for the first time Patients who are eligible to be initiated on HAART at the UWCoptic Hope Center for Infectious Diseases will be referred for enrollment Eligible patients who are referred will learn about the study and be invited to enroll after signing a written informed consent
Study participants will be randomized to one of four armseducational counseling a pocket alarm device both education and alarm or neither Participants will be followed in the study for 1 ½ years after enrollment and randomization Participants will return to clinic every month to pick up a renewal of their antiretroviral prescriptions at which time pill counts will be performed During follow-up visits blood will be drawn and stored for CD4 counts and HIV-1 viral analyses
Within this trial the study also proposes to identify sociodemographic and spatial correlates of adherence The study hypothesizes that educational counseling and medication alarm devices may significantly improve adherence and that poor adherence may be associated with low socioeconomic standing increased mobility and distance from clinic
Study participants will be randomized to one of four armseducational counseling a pocket alarm device both education and alarm or neither Participants will be followed in the study for 1 ½ years after enrollment and randomization Participants will return to clinic every month to pick up a renewal of their antiretroviral prescriptions at which time pill counts will be performed During follow-up visits blood will be drawn and stored for CD4 counts and HIV-1 viral analyses
Within this trial the study also proposes to identify sociodemographic and spatial correlates of adherence The study hypothesizes that educational counseling and medication alarm devices may significantly improve adherence and that poor adherence may be associated with low socioeconomic standing increased mobility and distance from clinic
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 |
|---|---|---|---|
| 5K23AI065222-02 | NIH | None | httpsreporternihgovquickSearch5K23AI065222-02 |
| 1K23AI065222-01 | NIH | None | None |