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Home > "A" Clinical Trials Conditions > A Medication Adherence Intervention for HIV Infected Veterans  A Medication Adherence Intervention for HIV Infected Veterans
A Medication Adherence Intervention for HIV Infected Veterans
For Condition: HIV Infection
Status: Not yet recruiting
Sponsor(s): Department of Veterans Affairs ,
Synopsis: 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. The purpose of this research is to evaluate a multi-component clinical intervention designed to optimize antiretroviral adherence and prevent drug resistance in veterans with HIV infection. Our specific aims are as follows: 1) to standardize and study the effectiveness of ACE Clinic, a pharmacist-led program to monitor, educate, and support HIV patients in their use of antiretroviral medicines; 2) to evaluate the effects of ACE Clinic on antiretroviral adherence, utilization of health services, costs, and patient satisfaction; 3) to describe, report on, and evaluate the process of ACE Clinic implementation using qualitative methods at the VA sites; 4) to use the ACE Clinics at participating sites as a mechanism to conduct ongoing efficient, multi-method field evaluation research and study promising, practical programs and technologies designed to support antiretroviral medication adherence; 5) to develop guidelines and materials for disseminating ACE Clinic programs within the Veterans Health Administration (VHA) and to conduct a national video teleconference to present ACE Clinic to HIV caregivers throughout the VA. This is a multi-center efficient quasi-experimental program-evaluation approach comparing patients at paired study sites randomly assigned to early vs. delayed program implementation. It uses combined quantitative and qualitative data collections that will test study hypotheses and provide insights about practical and operational program implementation issues from the perspectives of all important stakeholders (physicians, patients, pharmacists, nurses, and administrators). To achieve our study goals, we will conduct a series of three prospective controlled sub-studies with randomization at the level of the clinic. Sub-study 1 will evaluate the effectiveness of the ACE Clinic with teaching of self-management education skills for improving antiretroviral medication adherence. Sub-study 2 will evaluate the benefit of a customizable computer pager system to remind patients of doses. Sub-study 3 will evaluate the effect on adherence of providing a peer-led group support program. The three sub-studies will be conducted sequentially. The ACE Clinics and adherence enhancement technologies will be implemented in a varied set of four VA medical centers that comprise the VA-Western Adherence Collaboration (VA-WAC). In addition to the principal outcome of antiretroviral medication adherence, patient diagnoses, virologic and immunologic parameters, quality of life, and utilization/cost outcomes will also be assessed.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 210
Location and Contact Information:
VA Greater Los Angeles Health Care System
Los Angeles, California, 90073
United States
Matthew Goetz 310-268-3015
VA San Diego Health Care System
San Diego, California, 92161
United States
Allen Gifford 858-552-8585
VA San Diego Health Care System
San Diego, California, 92161
United States
Samuel Bozzette 858-552-4324
Southern Arizona VA Health Care System
Tucson, Arizona, 85723-0001
United States
Neil Ampel 520-792-1450
Additional Information:
Study ID Numbers: HII 99-054;
Study Start Date: July 2000
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013065
Other Hiv Infection Studies:
1. Adefovir Dipivoxil to Treat Hepatitis B in HIV-Infected Patients
2. A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy
3. Use of Bromodeoxyuridine to Study White Blood Cell Replication and Survival in HIV-Infected Patients
4. Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals
5. Study of Patients with Strongyloides stercoralis Infection
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Other HIV Infection Clinical Trials
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A Medication Adherence Intervention for HIV Infected Veterans
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