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OpenTrials
Completed

NCT Number: NCT01038076

Medications for Chronic HIV: Education and Collaboration

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MedCHEC Tablet Computer & Adherence Care

Behavioral

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

Primary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • 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

Registry information

Official study title

Implementing Computerized Clinical Assessment of HIV Patient Adherence

Acronym: MedCHEC

Important dates

Study start
2009
Primary completion
2013
Study completion
2017
First posted
Dec 23, 2009
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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