Clinical trial NCT01038076: Medications for Chronic HIV: Education and Collaboration
Official title: Implementing Computerized Clinical Assessment of HIV Patient Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Medication Adherence
Keywords: HIV
AIDS
adherence
antiretroviral
aCASI
HAART
Complementary Therapies
Adherence Care Manager
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: VA Office of Research and Development
name: VA Boston Healthcare System
name: VA Greater Los Angeles Healthcare System
name: San Diego State University
name: Tufts University
First posted: 2009-12-23
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles
state: California
city: Boston
country: United States
facility: VA Boston
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University School of Public Health and School of Medicine
name: Allen L Gifford, M.D.
role: PRINCIPAL_INVESTIGATOR
References: