Observational Study of Chronic Diseases

This is an observational study called OPERA, which aims to improve how we use electronic health records (EHR) to understand and manage chronic diseases like HIV/AIDS, liver diseases, inflammatory bowel diseases, and cardiovascular diseases. Instead of testing a new treatment, researchers will look at existing patient data from doctors' offices to learn more about how these conditions are treated in the real world. The study will track how well patients respond to their current therapies, specifically looking at their virologic response (how well a treatment controls a virus) after one year. This study is open to patients of all ages and genders who are treated in participating practices and whose treatment information is in their electronic health records. The study is currently unclear on its recruitment status and plans to include a very large number of participants.

Study design
This is an observational study with no specified phase, meaning researchers will only collect and analyze existing health data. It plans to enroll 2,000,000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, virologic response to therapy, is measured at 1 year.

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NCT03813862

Observational Pharmaco-Epidemiology Research & Analysis

Recruiting
Not specifiedAges 0+Observational
Epividian
~2,000,000 participants
Updated 2025-02-25 on ClinicalTrials.gov
What's tested:Non-interventional (observational only)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Virologic response to therapy
Measured over 1 year
Chronic Disease
HIV/AIDS
Liver Diseases
Inflammatory Bowel Diseases
Cardiovascular Diseases
Rheumatic Diseases
Neurodegenerative Diseases
1 sites across 1 states
North Carolina1

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Eligibility criteria

Inclusion

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

Patients who opt out of OPERA
  • Virologic response to therapy1 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.