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| Sponsored by: |
Department of Veterans Affairs |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00013065 |
Purpose
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.
| Condition |
|
HIV Infection |
| MedlinePlus related topics: | AIDS |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | A Medication Adherence Intervention for HIV Infected Veterans |
| Estimated Enrollment: | 210 |
| Study Completion Date: | December 2003 |
| Groups/Cohorts |
| 1 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| United States, Arizona | |||||
| Southern Arizona VA Health Care System | |||||
| Tucson, Arizona, United States, 85723-0001 | |||||
| United States, California | |||||
| VA Greater Los Angeles Healthcare System, West LA | |||||
| Los Angeles, California, United States, 90073-1002 | |||||
| VA Palo Alto Health Care System | |||||
| Palo Alto, California, United States, 94304-1207 | |||||
| VA San Diego Health Care System | |||||
| San Diego, California, United States, 92161 | |||||
| United States, Massachusetts | |||||
| Edith Nourse Rogers Memorial Veterans Hospital, Be | |||||
| Bedford, Massachusetts, United States, 01730 | |||||
| Principal Investigator: | Allen L. Gifford, MD | Edith Nourse Rogers Memorial Veterans Hospital, Be |
More Information
| Responsible Party: | Department of Veterans Affairs ( Gifford, Allen - Principal Investigator ) |
| Study ID Numbers: | HII 99-054 |
| First Received: | March 14, 2001 |
| Last Updated: | October 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00013065 |
| Health Authority: | United States: Federal Government |
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