Medications for Chronic HIV: Education and Collaboration

HIV Infections Clinical Trial

— MedCHEC  

Official title:

Implementing Computerized Clinical Assessment of HIV Patient Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038076
• Other study ID #: H-26736
• Secondary ID: R01MH076911-02
• Status: Completed
• Phase: N/A
• First received: December 19, 2009
• Last updated: February 17, 2018
• Start date: December 2009
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: December 2017
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	VA Boston	Boston	Massachusetts
United States	VA Greater Los Angeles	Los Angeles	California

Sponsors (7)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH), San Diego State University, Tufts University, VA Boston Healthcare System, VA Greater Los Angeles Healthcare System, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.		1 year