Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130273
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2005-08-11
Brief Title:
Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Managed Problem Solving An HIV Adherence Trial
Status:
COMPLETED
Status Verified Date:
2012-07
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:
MAPS
Brief Summary:
This study will determine whether a managed problem solving intervention can help patients with HIV better follow their anti-HIV drug regimen and can control HIV better than the standard of care
Detailed Description:
HAART is considered to be the most effective treatment for HIV However sustained and consistent adherence to HAART is necessary for long-term success Issues such as memory problems lack of social support medication side effects depression and substance abuse can significantly reduce patient adherence to HAART This study will evaluate the effectiveness of a managed problem solving strategy to increase HAART adherence in patients with HIV Both treatment-naive and treatment-experienced participants will be recruited for this study
The treatment part of this study will last 12 months Participants will be randomly assigned to receive the managed problem solving intervention or standard of care for 12 months Participants in the managed problem solving group will have 4 study visits and will receive 3 phone calls for the first 3 months of the study and 1 phone call every month for the following 9 months At each study visit participants will identify barriers to adherence During the phone calls participants will be asked about any steps they have taken to improve their adherence A medication event monitoring system MEMS will be used to assess participants treatment adherence MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count Follow-up phone interviews will be conducted every year for 3 years after the end of treatment
Study hypothesis Managed problem solving will result in better adherence to highly active antiretroviral therapy HAART and better virologic control and immunological outcomes at the end of 1 year compared with a control group receiving standard or care
The treatment part of this study will last 12 months Participants will be randomly assigned to receive the managed problem solving intervention or standard of care for 12 months Participants in the managed problem solving group will have 4 study visits and will receive 3 phone calls for the first 3 months of the study and 1 phone call every month for the following 9 months At each study visit participants will identify barriers to adherence During the phone calls participants will be asked about any steps they have taken to improve their adherence A medication event monitoring system MEMS will be used to assess participants treatment adherence MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count Follow-up phone interviews will be conducted every year for 3 years after the end of treatment
Study hypothesis Managed problem solving will result in better adherence to highly active antiretroviral therapy HAART and better virologic control and immunological outcomes at the end of 1 year compared with a control group receiving standard or care
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 |
|---|---|---|---|
| DAHBR 9A-ASPG | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH067498 |
| R01MH067498 | NIH | None | None |