A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
NCT ID: NCT00001129
Last Updated: 2013-10-01
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
NA
1248 participants
INTERVENTIONAL
2003-06-30
Brief Summary
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It is very important that HIV-positive patients take their anti-HIV medications correctly so they get the best possible benefit from them. Taking the drugs correctly, called "adherence," may keep HIV virus levels in the blood (viral load) low for a longer time. However, anti-HIV medication schedules are often complicated, and many patients have difficulty remembering to take their drugs at the correct time. This study will look at 2 different ways to teach patients about the importance of taking their medications correctly and to remind them when to take their medications.
Detailed Description
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Clinical sites, rather than individual patients, are randomized to one of four groups: a medication manager, an electronic medication reminder system, a medication manager plus an electronic medication reminder system, or usual care. Special training sessions are held for the staff of participating units assigned to medication manager and/or electronic medication reminder system interventions. The medication manager is a research staff member who works individually with study patients, addressing the knowledge, motivation, and skills necessary for adherence. The electronic medication reminder system is ALR (A Little Reminder). This is a small, portable alarm that is programmed to sound and flash at the times of the patient's scheduled AR medication doses. Patients enrolling into either the FIRST or MDR-HIV study at clinical sites authorized to carry out this study are offered the option of participating in the adherence intervention to which the clinical site has been randomly assigned. Data collected through the FIRST and the MDR-HIV protocols are used to address the Adherence study objectives. Patients on the FIRST protocol are assessed for time to first plasma HIV-RNA level above 2,000 copies/ml. Also, patients on the FIRST and MDR-HIV studies are assessed for changes in viral load, resistance, CD4 cell counts, adherence, and other factors.
Conditions
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Keywords
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Study Design
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FACTORIAL
TREATMENT
Interventions
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Electronic Medication Reminder System
Medication Manager
Eligibility Criteria
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Inclusion Criteria
* Are enrolling in a qualifying CPCRA AR therapeutic study. Currently, the FIRST and MDR-HIV studies are the only qualifying protocols.
Exclusion Criteria
* Are enrolling at a clinic site that is unable to participate in this study for some reason.
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Sharon Mannheimer
Role: STUDY_CHAIR
Edward Morse
Role: STUDY_CHAIR
Locations
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Community Consortium / UCSF
San Francisco, California, United States
Virginia Cafaro M.D.
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Univ Hosp Infectious Diseases Clinic
Denver, Colorado, United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Partners in Research / New Mexico
Albuquerque, New Mexico, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, United States
Bronx-Lebanon Hosp Ctr
The Bronx, New York, United States
The Research and Education Group
Portland, Oregon, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Univ TX Health Science Ctr
Houston, Texas, United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, United States
Countries
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Other Identifiers
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11617
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 062
Identifier Type: -
Identifier Source: org_study_id