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A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly Clinical research trials and A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly. A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly clinical trial. Test subjects typically obtain the finest healthcare available for their A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly  A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Factorial Assignment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 1248
Location and Contact Information:
Overall Study Official:
SharonMannheimer, Study Chair,
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131
United States
Univ TX Health Science Ctr
Houston, Texas, 77030
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Virginia Cafaro M.D.
San Francisco, California, 94110
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, 08103
United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
United States
Bronx-Lebanon Hosp Ctr
Bronx, New York, 10453
United States
Yale Univ School of Medicine / AIDS Program
New Haven, Connecticut, 06510
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York City, New York, 10037
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Community Consortium / UCSF
San Francisco, California, 94110
United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 232980049
United States
Univ Hosp Infectious Diseases Clinic
Denver, Colorado, 80204
United States
Additional Information:
Study ID Numbers: CPCRA 062;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001129
Other Hiv Infections Studies:
1. A Treatment Protocol for the Use of Trimetrexate With Leucovorin Rescue for AIDS Patients with Pneumocystis carinii Pneumonia and Serious Intolerance to Approved Therapies
2. Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3
3. The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used with or without Clofazimine in the Treatment of MAC in Patients with AIDS
4. A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)
5. A Study of Capravirine Plus VIRACEPT Plus Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Patients Who Failed Previous Anti-HIV Treatments
Related Studies:
Other HIV Infections Clinical Trials
Other New Jersey Clinical Trials
Other Camden Clinical Trials
A Study of Two Adherence Plans to Help HIV-Positive Patients Take Their Medications Correctly
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