Medications for Chronic HIV: Education and Collaboration (MedCHEC)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections Acquired Immunodeficiency Syndrome Medication Adherence |
Behavioral: MedCHEC tablet computer and Adherence Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Implementing Computerized Clinical Assessment of HIV Patient Adherence |
- Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 348 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: MedCHEC tablet computer and 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.
Other Names:
|
|
No Intervention: Adherence Information Only
Patients assigned to the active comparator arm will receive standard information about 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, California | |
| VA Greater Los Angeles | Not yet recruiting |
| Los Angeles, California, United States, 90073 | |
| Contact: Gina Akopyan 310-478-3711 ext 49514 gina.akopyan@va.gov | |
| Principal Investigator: Matthew Goetz, M.D. | |
| United States, Massachusetts | |
| Boston Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Vicki Crowningsheild 617-638-7909 vicki.crowningsheild@bmc.org | |
| Principal Investigator: Paul Skolnik, M.D. | |
| Sub-Investigator: Helene Hardy, PharmD | |
| VA Boston | Not yet recruiting |
| Boston, Massachusetts, United States, 02030 | |
| Contact: Linda McCoy 781-687-3417 linda.mccoy@va.gov | |
| Principal Investigator: Allen L Gifford, M.D. | |
| Principal Investigator: | Allen L Gifford, M.D. | Boston University School of Public Health and School of Medicine |
More Information
No publications provided
| Responsible Party: | Allen L. Gifford, Professor of Public Health and Medicine, Boston University |
| ClinicalTrials.gov Identifier: | NCT01038076 History of Changes |
| Other Study ID Numbers: | MedCHEC, R01MH076911-02 |
| Study First Received: | December 19, 2009 |
| Last Updated: | February 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston University:
|
HIV AIDS adherence antiretroviral |
aCASI HAART Complementary Therapies Adherence Care Manager |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013