A Medication Adherence Intervention for HIV Infected Veterans
NCT ID: NCT00013065
Last Updated: 2015-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
210 participants
OBSERVATIONAL
2003-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Group 1
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Allen L. Gifford, MD
Role: PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA
Locations
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Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Countries
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References
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Shively M, Smith TL, Bormann J, Gifford A. Evaluating Self-Efficacy for HIV Disease Management Skills. AIDS and behavior. 2002 Dec 1; 6(4):371-379.
Gifford AL, Groessl EJ. Chronic disease self-management and adherence to HIV medications. J Acquir Immune Defic Syndr. 2002 Dec 15;31 Suppl 3:S163-6. doi: 10.1097/00126334-200212153-00016.
Gifford AL, Bormann JE, Shively MJ, Wright BC, Richman DD, Bozzette SA. Predictors of self-reported adherence and plasma HIV concentrations in patients on multidrug antiretroviral regimens. J Acquir Immune Defic Syndr. 2000 Apr 15;23(5):386-95. doi: 10.1097/00126334-200004150-00005.
Korthuis PT, Asch S, Mancewicz M, Shapiro MF, Mathews WC, Cunningham WE, McCutchan JA, Gifford A, Lee ML, Bozzette SA. Measuring medication: do interviews agree with medical record and pharmacy data? Med Care. 2002 Dec;40(12):1270-82. doi: 10.1097/01.MLR.0000036410.86742.27.
Bormann J, Shively M, Smith TL, Gifford AL. Measurement of fatigue in HIV-positive adults: reliability and validity of the Global Fatigue Index. J Assoc Nurses AIDS Care. 2001 May-Jun;12(3):75-83. doi: 10.1016/S1055-3290(06)60146-5.
Other Identifiers
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HII 99-054
Identifier Type: -
Identifier Source: org_study_id
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