Medications for Chronic HIV: Education and Collaboration (MedCHEC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Boston University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
VA Boston Healthcare System
VA Greater Los Angeles Healthcare System
San Diego State University
Tufts University
Information provided by (Responsible Party):
Allen L. Gifford, Boston University
ClinicalTrials.gov Identifier:
NCT01038076
First received: December 19, 2009
Last updated: February 28, 2012
Last verified: February 2012

December 19, 2009
February 28, 2012
December 2009
June 2012   (final data collection date for primary outcome measure)
Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01038076 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Medications for Chronic HIV: Education and Collaboration
Implementing Computerized Clinical Assessment of HIV Patient Adherence

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Medication Adherence
Behavioral: MedCHEC tablet computer and 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
  • 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.
    Intervention: Behavioral: MedCHEC tablet computer and Adherence Care
  • No Intervention: Adherence Information Only
    Patients assigned to the active comparator arm will receive standard information about adherence.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
348
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01038076
MedCHEC, R01MH076911-02
Yes
Allen L. Gifford, Boston University
Boston University
  • National Institute of Mental Health (NIMH)
  • Department of Veterans Affairs
  • VA Boston Healthcare System
  • VA Greater Los Angeles Healthcare System
  • San Diego State University
  • Tufts University
Principal Investigator: Allen L Gifford, M.D. Boston University School of Public Health and School of Medicine
Boston University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP