Medications for Chronic HIV: Education and Collaboration

Not Applicable

Completed

• Conditions: HIV Infections; Medication Adherence; Acquired Immunodeficiency Syndrome
• Interventions: Behavioral: MedCHEC Tablet Computer & Adherence Care

• Registration Number: NCT01038076
• Lead Sponsor: Boston University

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-19
• Study First Submitted QC: 2009-12-19
• Study First Posted: 2009-12-23
• Primary Completion: 2013-06
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-17
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MedCHEC Tablet Computer & Adherence Care	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.

Primary Outcome Measures

Name	Time	Method
Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.	1 year

Trial Locations

Locations (3)

VA Greater Los Angeles; 🇺🇸 Los Angeles, California, United States

VA Boston; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States