Recruiting

Observational Study

Sponsor:

Epividian

Code:

NCT03813862

Conditions

Chronic Disease

HIV/AIDS

Liver Diseases

Inflammatory Bowel Diseases

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Non-interventional (observational only)

Study Details

Brief 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 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.

Conditions

Chronic Disease

HIV/AIDS

Liver Diseases

Inflammatory Bowel Diseases

Cardiovascular Diseases

Study ID

NCT03813862

Start date

Dec 1, 2013

Status verified date

Sep, 2026

Completion date

Nov, 2035

Anticipated

Primary completion date

Nov, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who opt out of OPERA

Study Design

Enrollment

2000000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Non-interventional (observational only)

Primary outcome measure

  • Virologic response to therapy [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Gregory Fusco, MD

224-632-1862gregory.fusco@epividian.com

Locations

Epividian

Recruiting

Durham, North Carolina, United States, 27703

Contacts

Rodney Mood

919-323-8728rodney.mood@epividian.com

More Information

Sponsor

Epividian

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Epividian on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.