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Medications for Chronic HIV: Education and Collaboration (MedCHEC)

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ClinicalTrials.gov Identifier: NCT01038076
Recruitment Status : Active, not recruiting
First Posted : December 23, 2009
Last Update Posted : March 31, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will examine whether a computerized, self-administered assessment of patient medication adherence and health behaviors, plus support for adherence, improves the ability of clinicians to identify adherence problems and leads to better adherence.

Condition or disease Intervention/treatment
HIV Infections Acquired Immunodeficiency Syndrome Medication Adherence Behavioral: MedCHEC Tablet Computer & Adherence Care

Detailed Description:
Antiretroviral medications are highly effective in controlling HIV, if patients adhere to the regimen. However, HIV medication adherence problems are very common, and evidence is clear that providers have great difficulty 'diagnosing' poor adherence accurately. If healthcare providers can identify patients with adherence problems, they can intervene to help patients overcome these problems and take their medications as prescribed, which can improve symptoms and quality and length of life. Both clinicians and HIV positive patients will be recruited to this study. Before each clinic visit, patients randomized to the intervention will be asked to answer questions about their medications, medication-taking behavior, and risk-factors for non-adherence on MedCHEC, a tablet touch-screen computer that generates provider and patient reports. We will give these reports to the provider and patient to assist with the clinical visit. Based on the MedCHEC-generated report, the patient may be referred to an Adherence Care Manager (ACM). The ACM will assist the patient in overcoming adherence barriers by telephone and in-clinic counseling. The study will evaluate the effects of this system on adherence and clinical care using both quantitative methods (randomized controlled trials of effects on adherence and providers' adherence estimates), and qualitative methods.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementing Computerized Clinical Assessment of HIV Patient Adherence
Actual Study Start Date : December 2009
Primary Completion Date : June 2013
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MedCHEC Tablet Computer & Adherence Care
Patients assigned to the intervention answer questions about their medication, medication-taking behavior and risks for non-adherence on the MedCHEC tablet touch-screen computer, which generates provider and patient reports. Patients may be referred to an Adherence Care Manager on the basis of the reports. In addition, patients will receive standard information about adherence.
Behavioral: MedCHEC Tablet Computer & Adherence Care
Patients answer questions about their medication, medication-taking behavior and risks for non-adherence on the MedCHEC tablet touch-screen computer, which generates patient and provider reports. Patients may be referred to an Adherence Care Manager on the basis of the reports.
Other Names:
  • HIV/Adhere
  • aCASI
No Intervention: Adherence Information Only
Patients assigned to the active comparator arm will receive standard information about adherence.


Outcome Measures

Primary Outcome Measures :
  1. Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age
  • Confirmed HIV-positive
  • On or newly starting antiretroviral medication for HIV
  • Under treatment at one of the study sites
  • Available by telephone

Exclusion Criteria:

  • Clinically diagnosed by provider with significant cognitive impairment, or Mini-Mental Status Exam score less than or equal to 22
  • Inability to read English
  • Inability or refusal to use MedCHEC touch-screen computer
  • Inability or refusal to use any form of electronic drug monitoring device (MEMS)
  • Never available by telephone
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038076


Locations
United States, California
VA Greater Los Angeles
Los Angeles, California, United States, 90073
United States, Massachusetts
VA Boston
Boston, Massachusetts, United States, 02030
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
National Institute of Mental Health (NIMH)
VA Office of Research and Development
VA Boston Healthcare System
VA Greater Los Angeles Healthcare System
San Diego State University
Tufts University
Investigators
Principal Investigator: Allen L Gifford, M.D. Boston University School of Public Health and School of Medicine
More Information

Responsible Party: Allen L. Gifford, Professor of Public Health and Medicine, Boston University
ClinicalTrials.gov Identifier: NCT01038076     History of Changes
Other Study ID Numbers: MedCHEC
R01MH076911-02 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allen L. Gifford, Boston University:
HIV
AIDS
adherence
antiretroviral
aCASI
HAART
Complementary Therapies
Adherence Care Manager

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases