Medications for Chronic HIV: Education and Collaboration

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementing Computerized Clinical Assessment of HIV Patient Adherence

Conditions
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HIV Infections, Acquired Immunodeficiency Syndrome, Medication Adherence

Intervention / Treatment
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* Behavioral: MedCHEC Tablet Computer & Adherence Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MedCHEC Tablet Computer & Adherence Care<br>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<br>* 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.<br>* Other names: aCASI;|
| No Intervention: Adherence Information Only<br>Patients assigned to the active comparator arm will receive standard information about adherence. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, adherence, antiretroviral, aCASI, HAART, Complementary Therapies, Adherence Care Manager