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Medications for Chronic HIV: Education and Collaboration

Implementing Computerized Clinical Assessment of HIV Patient Adherence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01038076
Acronym
MedCHEC
Enrollment
371
Registered
2009-12-23
Start date
2009-12-31
Completion date
2017-12-31
Last updated
2018-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Immunodeficiency Syndrome, HIV Infections, Medication Adherence

Keywords

HIV, AIDS, adherence, antiretroviral, aCASI, HAART, Complementary Therapies, Adherence Care Manager

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.

Interventions

BEHAVIORALMedCHEC 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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
VA Office of Research and Development
CollaboratorFED
VA Boston Healthcare System
CollaboratorFED
VA Greater Los Angeles Healthcare System
CollaboratorFED
San Diego State University
CollaboratorOTHER
Tufts University
CollaboratorOTHER
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026