Chronic DiseaseOPERANCT03813862
Observational Pharmaco-Epidemiology Research & Analysis
An observational study of Chronic Disease and HIV/AIDS, run by Epividian at 1 site in United States.
Trial summary
Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management; and 2) the use of the point-of-care observational data from the provider-patient encounter… Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, HIV/AIDS, Liver Diseases
- What is being tested?
- Non-interventional (observational only)
- How many people
- 2,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2013to Nov 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The patient population includes a diverse group of individuals treated in ambulatory practice with a focus on those living with chronic disease.
Who may be able to join
- Patients who are treated in the practices who enroll and participate in the study
- Patients whose treatment is documented in the practice's electronic health record system
Who cannot join
- Patients who opt out of OPERA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Epividian
Durham, North Carolina, 27703
Rodney Mood, 919-323-8728, rodney.mood@epividian.com
About this study
Official title: OPERA Longitudinal Observational Database in the Study of Chronic Diseases, Treatments and Outcomes
Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management; and 2) the use of the point-of-care observational data from the provider-patient encounter that support realworld medical research and healthcare quality measure assessment. Real-world evaluations of treatments of chronic diseases in the context of comorbid conditions and special populations (minorities, women, mentally ill, and those with addiction) are limited. The purpose of the OPERA database is to help address this unmet need in clinical research.
Read the detailed description
Objectives of OPERA
- To research numerous chronic diseases (HIV, HCV, HBV currently and IBD and RA in the near future, with others as identified for further consideration) utilizing the OPERA® longitudinal database that consists of de-identified EHR data from numerous clinical practices in a variety of settings (e.g. solo practitioners, small groups, and hospitals). Research will be ongoing and yield numerous individual analyses and reports that are authored by epidemiologists, practicing physicians, pharmaco-economists, and other researchers and will target scientific conferences and peer-reviewed medical journals for dissemination.
- To use epidemiological, statistical, and data analysis methods and related research findings to deliver a sophisticated healthcare analytics reporting solution (CHORUS™) to clinicians.†
- To enhance patient population management as well as disease management capabilities of the practicing physician.
- To provide anonymous, nation-wide benchmarking of quality measures and key performance indicators (KPI) for medical clinics.
- To enhance patient engagement with their physicians to deliver better health outcomes.
- To evaluate whether engagement in care by patients with their physicians results in better outcomes for patients with chronic illness.
- Conditions
- Chronic Disease, HIV/AIDS, Liver Diseases, Inflammatory Bowel Diseases, Cardiovascular Diseases, Rheumatic Diseases
- Being tested
- Non-interventional (observational only)
- Medical subject headings
- Chronic Disease, Acquired Immunodeficiency Syndrome, Liver Diseases, Inflammatory Bowel Diseases, Cardiovascular Diseases, Rheumatic Diseases, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional (observational only)Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic response to therapy
HIV-1 PCR laboratory value ("viral load") quantifies the amount of HIV-1 copies in plasma per mL. The baseline viral load is compared to viral load after 1 year of antiretroviral therapy.
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 Jan 2019
- Study start1 Dec 2013
- Primary completionNov 2035 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epividian
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813862
- Sponsor's protocol ID
- Pro00023648
- Acronym
- OPERA
- Status last verified
- Sep 2026
- First submitted
- 11 Jan 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPERA Longitudinal Observational Database in the Study of Chronic Diseases, Treatments and Outcomes
- ClinicalTrials.gov ID
- NCT03813862
- Acronym / sponsor ID
- OPERA / Pro00023648
- Conditions
- Chronic Disease, HIV/AIDS, Liver Diseases, Inflammatory Bowel Diseases, Cardiovascular Diseases, Rheumatic Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000,000 participants (estimated)
- Lead sponsor
- EpividianIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- Nov 2035 (estimated)
- Study completion
- Nov 2035 (estimated)
- First posted
- 23 Jan 2019 (actual)
- 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.
Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management; and 2) the use of the point-of-care observational data from the provider-patient encounter that support realworld medical research and healthcare quality measure assessment. Real-world evaluations of treatments of chronic diseases in the context of comorbid conditions and special populations (minorities, women, mentally ill, and those with addiction) are limited. The purpose of the OPERA database is to help address this unmet need in clinical research.
Detailed description
Objectives of OPERA
- To research numerous chronic diseases (HIV, HCV, HBV currently and IBD and RA in the near future, with others as identified for further consideration) utilizing the OPERA® longitudinal database that consists of de-identified EHR data from numerous clinical practices in a variety of settings (e.g. solo practitioners, small groups, and hospitals). Research will be ongoing and yield numerous individual analyses and reports that are authored by epidemiologists, practicing physicians, pharmaco-economists, and other researchers and will target scientific conferences and peer-reviewed medical journals for dissemination.
- To use epidemiological, statistical, and data analysis methods and related research findings to deliver a sophisticated healthcare analytics reporting solution (CHORUS™) to clinicians.†
- To enhance patient population management as well as disease management capabilities of the practicing physician.
- To provide anonymous, nation-wide benchmarking of quality measures and key performance indicators (KPI) for medical clinics.
- To enhance patient engagement with their physicians to deliver better health outcomes.
- To evaluate whether engagement in care by patients with their physicians results in better outcomes for patients with chronic illness.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient population includes a diverse group of individuals treated in ambulatory practice with a focus on those living with chronic disease.
Key inclusion criteria (2 listed)
- Patients who are treated in the practices who enroll and participate in the study
- Patients whose treatment is documented in the practice's electronic health record system
Key exclusion criteria (1 listed)
- Patients who opt out of OPERA
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 |
|---|---|---|
| Non-interventional (observational only) | Other | – |
Primary outcome
Virologic response to therapy
Time frame: 1 year
HIV-1 PCR laboratory value ("viral load") quantifies the amount of HIV-1 copies in plasma per mL. The baseline viral load is compared to viral load after 1 year of antiretroviral therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and HIV/AIDS, run by Epividian at 1 site 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Fusco, MD (224-632-1862, gregory.fusco@epividian.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic response to therapy (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 11 Sep 2026.