A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
- Conditions
- HIV Infections
- Registration Number
- NCT00001129
- Brief Summary
The purpose of this study is to look at different ways to help patients follow their anti-HIV medication schedules.
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
Adherence to antiretroviral (AR) therapy has become increasingly important in the management of HIV infection. Adherence to AR regimens is thought to be a critical factor in maintaining therapeutic drug levels, thus helping ensure viral suppression and minimizing the risk of drug resistance. However, AR regimens are often complex with demanding dosing schedules. Patients often miss doses because they simply forget; other factors such as substance abuse, depression, and low literacy levels also contribute to nonadherence. Adherence is influenced not only by individual behavior but also by the services, the quality of the patient-provider relationship, and the amount of social support offered the patient. There is no currently agreed upon, widely used, and generalizable intervention for improving adherence over the long course of HIV therapy. This study provides a long-term comparative evaluation of two interventions.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1248
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Partners in Research / New Mexico
🇺🇸Albuquerque, New Mexico, United States
Bronx-Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Richmond AIDS Consortium / Div of Infect Diseases
🇺🇸Richmond, Virginia, United States
Community Consortium / UCSF
🇺🇸San Francisco, California, United States
Virginia Cafaro M.D.
🇺🇸San Francisco, California, United States
Univ TX Health Science Ctr
🇺🇸Houston, Texas, United States
Univ Hosp Infectious Diseases Clinic
🇺🇸Denver, Colorado, United States
Denver CPCRA / Denver Public Hlth
🇺🇸Denver, Colorado, United States
Washington Reg AIDS Prog / Dept of Infect Dis
🇺🇸Washington, District of Columbia, United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
🇺🇸New York, New York, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Yale Univ School of Medicine / AIDS Program
🇺🇸New Haven, Connecticut, 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
Southern New Jersey AIDS Clinical Trials
🇺🇸Camden, New Jersey, United States