HIV/HBV/HCV Triple Screening in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: electronic medical record alert linked to orders.
- Who it may be relevant to
- Registry conditions: HIV, HBV (Hepatitis B Virus), HCV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Syndemic Triple HIV/HBV/HCV Virus Screening Via EMR Automation at Primary Care Clinics
Overview
Design: This will be a within-subjects repeated-measures design, testing an electronic medical record pop-up alert linked to order panels for screening blood tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). Study participants will be primary care providers. For each participating provider, their encounter will be randomized to either control (no alert; no changes to EMR interface) or an alert with triple-testing order panel intervention arm (alert linked to order panel with screening tests for all three bloodborne viruses (BBVs) selected by default; the alert will be triggered when a provider attempts to order a screening test for at least one BBV). The alert linked to triple testing orders will only be triggered if the provider orders a virus BBV screening test based on their normal practice and standard of care for their patient. Providers will see which orders are selected prior to signing (finalizing) them; therefore, this study will be unblinded. To mitigate the effect of unblinding, randomization will occur at the encounter level which will lead to providers experiencing both the control and intervention conditions randomly throughout the duration of the study. Outcomes/endpoints: The investigators will compare incidences of HIV, HBV, and HCV diagnoses between the two encounter conditions, estimate number of cases missed by not triple-testing, estimate laboratory costs per condition, and measure patient encounters per condition.
Interventions
- Other electronic medical record alert linked to orders
An electronic medical record alert linked to triple testing orders will be built specifically for this study. An order for a screening blood test for any of the three bloodborne viruses (BBVs; i.e. HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)) will trigger an electronic medical record alert linked to orders for screening blood tests for all three BBVs to be selected by default. If participants accept the alert, the individual BBV order that triggered the alert will be replaced with t
Primary outcome measures
- Bloodborne virus (BBV) screening tests [Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)]
Secondary outcome measures (5)
- Prevalences of bloodborne viruses (BBVs) [Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)]
- Incidences of bloodborne viruses (BBVs) [Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)]
- Number of patient encounters required to make a virus diagnosis and link patients to care [Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)]
- Cost efficiency analysis [Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)]
- Repeated BBV tests [Time frame: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)]
Eligibility criteria
Inclusion criteria
- Outpatient primary care adult providers at participating institutions
- Providers who provide consent to participate in this study.
- Providers must intend to continue their current practice for at least 12 months.
- Providers with at least 12 months experience in their current practice.
Exclusion criteria
- Providers who do not consent to participate
- Sub-specialty providers
- Pediatric providers
- Providers who anticipate leaving their current practice within the next 12 months (i.e. providers who plan to retire, move, etc.).
- Providers with less than 12 months experience in their current practice (i.e. new providers or trainees who joined the practice within the last year)
- Note: family medicine and med/peds providers can participate, but only for their adult patients. The intervention alert+order panel and any data collection will be restricted to adult patients ≥ 18 years old.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT07031219 · STU20240019 · IN-US-973-7442