HIV InfectionsMedCHECNCT01038076
Medications for Chronic HIV: Education and Collaboration
A study testing MedCHEC Tablet Computer & Adherence Care in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by Boston University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome, Medication Adherence
- What is being tested?
- MedCHEC Tablet Computer & Adherence Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2009to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Boston
Boston, Massachusetts, 02030
Boston Medical Center
Boston, Massachusetts, 02118
VA Greater Los Angeles
Los Angeles, California, 90073
About this study
Official title: Implementing Computerized Clinical Assessment of HIV Patient Adherence
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.
Read the 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.
- Being tested
- MedCHEC Tablet Computer & Adherence Care
- Keywords
- HIV, AIDS, adherence, antiretroviral, aCASI, HAART, Complementary Therapies, Adherence Care Manager
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedCHEC Tablet Computer & Adherence CareBehavioural
Also called HIV/Adhere, aCASI
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.
| Study group | Role | What they receive |
|---|---|---|
| MedCHEC Tablet Computer & Adherence Care | Experimental | 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. Receives: Behavioral: MedCHEC Tablet Computer & Adherence Care |
| Adherence Information Only | No intervention | Patients assigned to the active comparator arm will receive standard information about adherence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2013
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), VA Office of Research and Development, VA Boston Healthcare System, VA Greater Los Angeles Healthcare System, San Diego State University, Tufts University
- Responsible party
- Principal investigator, Allen L. Gifford, Boston University
- Investigators
- Allen L Gifford, M.D., Principal investigator, Boston University School of Public Health and School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038076
- Sponsor's protocol ID
- H-26736
- Other IDs
- R01MH076911-02
- Acronym
- MedCHEC
- Status last verified
- Feb 2018
- First submitted
- 19 Dec 2009
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Computerized Clinical Assessment of HIV Patient Adherence
- ClinicalTrials.gov ID
- NCT01038076
- Acronym / sponsor ID
- MedCHEC / H-26736
- Keywords
- HIV, AIDS, adherence, antiretroviral, aCASI, HAART, Complementary Therapies, Adherence Care Manager
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), VA Office of Research and Development, VA Boston Healthcare System, VA Greater Los Angeles Healthcare System, San Diego State University, Tufts University
- Study start
- Dec 2009 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MedCHEC Tablet Computer & Adherence Care | Experimental | Behavioral: MedCHEC Tablet Computer & Adherence CarePatients 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. |
| Adherence Information Only | No intervention | –Patients assigned to the active comparator arm will receive standard information about adherence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedCHEC Tablet Computer & Adherence CareAlso: HIV/Adhere, aCASIPatients 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. | Behavioural | MedCHEC Tablet Computer & Adherence Care |
Primary outcome
Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen L Gifford, M.D. principal investigator
Boston University School of Public Health and School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedCHEC Tablet Computer & Adherence Care in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by Boston University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient adherence to HIV medications, as measured by MEMS data, and by self-report questionnaires. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.