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Medications for Chronic HIV: Education and Collaboration (MedCHEC)

Primary Purpose

HIV Infections, Acquired Immunodeficiency Syndrome, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MedCHEC Tablet Computer & Adherence Care
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections focused on measuring HIV, AIDS, adherence, antiretroviral, aCASI, HAART, Complementary Therapies, Adherence Care Manager

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Greater Los Angeles
  • VA Boston
  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MedCHEC Tablet Computer & Adherence Care

Adherence Information Only

Arm Description

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.

Patients assigned to the active comparator arm will receive standard information about adherence.

Outcomes

Primary Outcome Measures

Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2009
Last Updated
February 17, 2018
Sponsor
Boston University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT01038076
Brief Title
Medications for Chronic HIV: Education and Collaboration
Acronym
MedCHEC
Official Title
Implementing Computerized Clinical Assessment of HIV Patient Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2009 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Acquired Immunodeficiency Syndrome, Medication Adherence
Keywords
HIV, AIDS, adherence, antiretroviral, aCASI, HAART, Complementary Therapies, Adherence Care Manager

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
371 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MedCHEC Tablet Computer & Adherence Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Adherence Information Only
Arm Type
No Intervention
Arm Description
Patients assigned to the active comparator arm will receive standard information about adherence.
Intervention Type
Behavioral
Intervention Name(s)
MedCHEC Tablet Computer & Adherence Care
Other Intervention Name(s)
HIV/Adhere, aCASI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen L Gifford, M.D.
Organizational Affiliation
Boston University School of Public Health and School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
VA Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02030
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Medications for Chronic HIV: Education and Collaboration

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