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RecruitingNCT03813862OPERAUpdated Sep 11, 2026

Observational Pharmaco-Epidemiology Research & Analysis

An observational study in Chronic Disease, HIV/AIDS and Liver Diseases, sponsored by Epividian. Recruiting at 1 site in United States. Open to participants aged 0 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Primary conditionAcquired Immunodeficiency SyndromeRegistry: Chronic DiseaseReclassifiedWhy we changed it
Registry
Chronic Disease — the first condition term the registry derived for this study.
ClinicalTrials.gg
Acquired Immunodeficiency Syndrome
Why
  1. Chronic Disease is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Acquired Immunodeficiency Syndrome.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Epividian · Observational

From the registry’s dates

  • Started Dec 2013; still recruiting 12 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000,000
Ages
0 Years and older
Sex
All
01

Study 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.

Read the detailed description

Objectives of OPERA

  1. 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.
  2. To use epidemiological, statistical, and data analysis methods and related research findings to deliver a sophisticated healthcare analytics reporting solution (CHORUS™) to clinicians.†
  3. To enhance patient population management as well as disease management capabilities of the practicing physician.
  4. To provide anonymous, nation-wide benchmarking of quality measures and key performance indicators (KPI) for medical clinics.
  5. To enhance patient engagement with their physicians to deliver better health outcomes.
  6. To evaluate whether engagement in care by patients with their physicians results in better outcomes for patients with chronic illness.
02

Conditions studied

  • Chronic Disease
  • HIV/AIDS
  • Liver Diseases
  • Inflammatory Bowel Diseases
  • Cardiovascular Diseases
  • Rheumatic Diseases
  • Neurodegenerative Diseases
03

In context

Acquired Immunodeficiency Syndrome Reclassified

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

This study's planned enrollment of 2,000,000 is above the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Epividian is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Compared within Acquired Immunodeficiency Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chronic Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The patient population includes a diverse group of individuals treated in ambulatory practice with a focus on those living with chronic disease.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who opt out of OPERA
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000,000 participants (estimated)
Patient registry
No

Interventions

  • OtherNon-interventional (observational only)
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Epividian
    Durham, North Carolina 27703, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03813862
Lead sponsor
Epividian
Responsible party
Sponsor
First posted
Jan 23, 2019
Start date
Dec 1, 2013
Primary completion
Nov 2035 (estimated)
Completion
Nov 2035 (estimated)
Last update
Sep 11, 2026

Study contacts

Gregory Fusco, MD
Contact
gregory.fusco@epividian.com
224-632-1862

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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