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A Medication Adherence Intervention for HIV Infected Veterans

This study has been completed.
Study NCT00013065.   Last updated on October 31, 2008.   Information provided by Department of Veterans Affairs

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Descriptive Information Fields
Brief Title  A Medication Adherence Intervention for HIV Infected Veterans
Official Title  A Medication Adherence Intervention for HIV Infected Veterans
Brief Summary

It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.

Detailed Description

Background:

It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To benefit from recent improvements in anti-HIV therapy, patients need to take their medications consistently.

Objectives:

Optimizing health for HIV patients requires excellent adherence to antiretroviral medication regimens. However, its unclear how best to incorporate adherence education and support programs into VA HIV outpatient care. We implemented and evaluated a pharmacist program (ACE) and a Pager reminder program to support adherence in veterans with HIV.

Methods:

We used a quasi-experimental design with pre-post evaluation at four VA Centers. Three treatment conditions (ACE, Pager, Usual Care) were rolled-in sequentially over two study phases, allowing for group comparisons between conditions. ACE is a multi-component manualized 4-session, individual patient education and support program by trained pharmacists. The Pager intervention used alphanumeric pagers to remind patients of dosing times. Electronically-monitored medication adherence (MEMS), self-report questionnaires, and pharmacy refill records were collected. Qualitative site interviews were collected before and after interventions to assist with program evaluation. Multilevel mixed models were used to analyze main study outcomes over time. Secondary analyses compared subgroup who actually received all ACE sessions (�as treated�) to controls.

Status:

Project has been completed and Final Report submitted to HSR&D CO.

Study Phase
Study Type  Observational
Study Design  Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infection
Intervention 
MEDLINE PMIDs 12562043,   12458308
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  210
Start Date 
Completion Date December 2003
Eligibility Criteria 

Inclusion Criteria:

Patients must be greater than or equal to 18 years old, must be enrolled in HIV Primary care at one of 4 VA study sites and be taking antiretroviral therapy.

Exclusion Criteria:

Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00013065
Organization ID HII 99-054
Secondary IDs ††
Study Sponsor  Department of Veterans Affairs
Collaborators ††
Investigators 
Principal Investigator:     Allen L. Gifford, MD     Edith Nourse Rogers Memorial Veterans Hospital, Be    
Information Provided By Department of Veterans Affairs
Verification Date January 2005
First Received Date  March 14, 2001
Last Updated Date October 31, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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