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.

Condition	Treatment or Intervention
HIV Infections	Device: Electronic Medication Reminder System  Behavior: Medication Manager

Further Study Details: 

Expected Total Enrollment:  1248

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.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are enrolling in a qualifying CPCRA AR therapeutic study. Currently, the FIRST and MDR-HIV studies are the only qualifying protocols.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Are enrolling at a clinic site that is unable to participate in this study for some reason.

California
      Community Consortium / UCSF, San Francisco,  California,  94110,  United States
      Virginia Cafaro M.D., San Francisco,  California,  94110,  United States
Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States
      Univ Hosp Infectious Diseases Clinic, Denver,  Colorado,  80204,  United States
Connecticut
      Yale Univ School of Medicine / AIDS Program, New Haven,  Connecticut,  06510,  United States
District of Columbia
      Washington Reg AIDS Prog / Dept of Infect Dis, Washington,  District of Columbia,  20422,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  303081962,  United States
Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States
Louisiana
      Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans,  Louisiana,  70112,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
      Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit,  Michigan,  48201,  United States
New Jersey
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States
      Southern New Jersey AIDS Clinical Trials, Camden,  New Jersey,  08103,  United States
New Mexico
      Partners in Research / New Mexico, Albuquerque,  New Mexico,  87131,  United States
New York
      Bronx-Lebanon Hosp Ctr, Bronx,  New York,  10453,  United States
      Harlem AIDS Treatment Grp / Harlem Hosp Ctr, New York,  New York,  10037,  United States
Oregon
      The Research and Education Group, Portland,  Oregon,  97210,  United States
Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States
Texas
      Univ TX Health Science Ctr, Houston,  Texas,  77030,  United States
Virginia
      Richmond AIDS Consortium / Div of Infect Diseases, Richmond,  Virginia,  232980049,  United States

Study chairs or principal investigators

Sharon Mannheimer,  Study Chair
Edward Morse,  Study Chair

Study ID Numbers:  CPCRA 062
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  January 17, 2000
ClinicalTrials.gov Identifier:  NCT00001129
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08