Medications for Chronic HIV: Education and Collaboration (MedCHEC)

Boston University

Status: Completed

Conditions: Medication Adherence; HIV Infections; Acquired Immunodeficiency Syndrome

Treatments: Behavioral: MedCHEC Tablet Computer & Adherence Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT01038076

R01MH076911-02 (U.S. NIH Grant/Contract)

H-26736

Details and patient eligibility

About

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.

Full 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.

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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371 participants in 2 patient groups

MedCHEC Tablet Computer & Adherence Care

Experimental group

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.

Treatment:

Behavioral: MedCHEC Tablet Computer & Adherence Care

Adherence Information Only

No Intervention group

Description:

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