MedCHEC: Medications for Chronic HIV: Education and Collaboration

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT01038076

Collaborator

National Institute of Mental Health (NIMH) (NIH), VA Office of Research and Development (U.S. Fed), VA Boston Healthcare System (U.S. Fed), VA Greater Los Angeles Healthcare System (U.S. Fed), San Diego State University (Other), Tufts University (Other)

371

Enrollment

Locations

Arms

Actual Duration (Months)

123.7

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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	Phase
HIV Infections Acquired Immunodeficiency Syndrome Medication Adherence	Behavioral: MedCHEC Tablet Computer & Adherence Care	N/A

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

Actual Enrollment :

371 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 :

Dec 1, 2009

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Dec 1, 2017

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.

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

Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Greater Los Angeles	Los Angeles	California	United States	90073
2	VA Boston	Boston	Massachusetts	United States	02030
3	Boston Medical Center	Boston	Massachusetts	United States	02118