Research and analysis

Protocol: public health evaluation of BBV opt-out testing in EDs in England, 33-month final report 2025

Updated 29 October 2025

Applies to England

Purpose

The protocol outlines the approach to conduct a public health evaluation of the NHS England (NHSE) emergency department (ED) opt-out blood borne virus (BBV) testing programme (‘the Programme’).

Aims

The public health evaluation aims to describe the impact and effectiveness of the ED BBV opt-out testing programme.

Objectives

The public health evaluation has the following objectives:

• to describe the effectiveness of the Programme in diagnosing and linking to care people who are newly diagnosed with a BBV, or previously diagnosed and not currently in care
• to describe the care pathway for individuals who are eligible for and tested positive for BBVs through the Programme
• to describe the extent to which testing in this setting reduces health inequalities in BBV testing
• to describe the effectiveness of the Programme over time

Background

In April 2022, implementation of an NHSE-funded Programme of opt-out testing of BBVs in EDs began in areas of very high diagnosed HIV prevalence (more than 5 per 1,000 people aged 15 to 59 years) and all Type 1 EDs in London serving areas of less than very high diagnosed HIV prevalence. According to NHSE programmatic data, in the first two years of testing across 34 EDs, 1,981,590 HIV tests, 1,502,799 hepatitis C virus (HCV) tests and 1,185,678 hepatitis B virus (HBV) tests were carried out. The scale of the Programme makes it a substantial contribution to all BBV testing in England, with the number of tests performed equivalent to more than half of all BBV tests performed in general practice, sexual health, drug and prison services combined (reported through the UK Health Security Agency (UKHSA) Sentinel Surveillance of Blood Borne Virus (SSBBV) testing system.

In the Public health evaluation of BBV opt-out testing in EDs in England, 12-month interim report 2023 (published in November 2023), UKHSA provided an interim public health evaluation of the first year of the Programme. Using linked datasets, analysis was undertaken of 16 sites to understand the characteristics and numbers of people newly and previously diagnosed, and the extent to which both groups were promptly linked to care. A deep dive of 5 sites was undertaken to investigate test uptake and positivity. An interim implementation optimisation evaluation, conducted by the University of Bristol, was also included in this report.

The Public health evaluation of BBV opt-out testing in EDs in England, 24-month interim report 2024 was published as a slide set and a short report in October 2024. This showed data for the period from April 2022 to end of March 2024. Data for 21 sites were published, including details of number of attendees tested and their demographics, and a comparison with those being tested in other settings. For those newly and previously diagnosed with HCV and HIV, known risk factors and linkage to care were explored.

The final evaluation was published in October 2025, covering the period from April 2022 until the end of December 2024. Separately, the University of Bristol have published final implementation optimisation report  in April 2025, and will publish an economic evaluation report later before the end of the year. This document describes the analysis protocol for the final public health evaluation report produced by the UKHSA.

Evaluation outputs

The outputs of the UKHSA public health evaluation are:

• 12-month evaluation report: published in November 2023
• 24-month evaluation report: published in October 2024 (a slide set with visual presentation of interim evaluation data with figures and key messages and short report)
• end of the Programme final 33-month evaluation report: published in October 2025

This protocol outlines the final evaluation report output.

Evaluation setting and participants

The evaluation will take place in EDs where the first wave of the Programme has been implemented, those serving all areas of very high diagnosed HIV prevalence in England, as well as all Type 1 EDs in London serving areas of less than very high diagnosed HIV prevalence. There are 34 sites participating in this wave of the Programme, all of which were actively testing for at least one BBV over the course of the 33-month evaluation. Participants are people aged 16 years and over (18 years and over at some sites) presenting at one of the participating EDs and having a blood test as part of their ED visit.

Methods

Evaluation questions and indicators

The evaluation aims to address a series of questions which are outlined in: Evaluation questions and indicators: public health evaluation of BBV opt-out testing in EDs in England, 33-month final report 2025. These questions are mapped to related output indicators across the care pathway.

The evaluation questions and indicators outlines the questions addressed in the final evaluation by UKHSA and University of Bristol and those deemed out of scope of this evaluation. The indicators were co-developed with the evaluation Advisory Group, NHSE, the University of Bristol and clinicians involved in the Programme.

Evaluation approach and theory of change

The evaluation uses a Theory of Change approach which describes how the Programme activities are expected to lead to the desired changes, including the contribution of ED testing to elimination targets, the Programme equity, the care cascade, and engagement with treatment and care. These are diagrammatically represented using logic models which show the relationship between the Programme activities, direct Programme outputs and long-term outcomes. Logic models for HBV, HCV, and HIV are shown in Appendix 2a  of the Public health evaluation of BBV opt-out testing in EDs in England, 12-month interim report 2023.

Using this theory helps to identify the desired long-term goals of the Programme and assess whether the Programme activities support the achievement of those goals. This in turn enables metrics (indicators) to be produced to show how well the Programme is achieving its stated aims. Furthermore, it supports the communication of the Programme and its intended outcomes by creating a narrative of the implementation of the Programme. The Theory of Change is a widely used and recommended framework for the evaluation of interventions.

Data sources

The public health evaluation uses routine surveillance and healthcare activity data. The data sources are outlined below:

• National Emergency Care Data Set (ECDS) for ED attendances, blood tests and demographic information
• UKHSA Second Generation Surveillance System (SGSS) provides routine laboratory data for new positive test results for hepatitis C and B; additional information on socio-demographics and adverse social conditions associated with poor health are also recorded, including ethnicity, residency, history of injecting drugs, site of testing, source of infection and homelessness
• UKHSA SSBBV provides all positive and negative test results for hepatitis A to E, HIV and HTLV from sentinel surveillance laboratories; results from testing for hepatitis B, C and HIV only will be used
• Arden and GEM NHSE Hepatitis C Patient Registry and Treatment Outcome System for previous and first HCV diagnoses, information on treatment, additional risk factors, stages of cirrhosis and outcome including sustained virologic response (SVR)
• HIV and AIDS reporting system (HARS) for HIV diagnoses, treatment information, and socio-demographic information such as ethnicity, age, gender, residency, and probable route of HIV exposure
• HIV and AIDS New Diagnoses Dataset (HANDD) for new diagnoses of HIV and additional information such as if an individual was diagnosed late
• Genitourinary Medicine Clinic Activity Dataset (GUMCAD) collects and reports data on sexually transmitted infection (STI) testing, diagnoses and services from all commissioned sexual health clinics in England and will be used to monitor hepatitis B, hepatitis C and HIV tests and diagnoses made at sexual health clinics, and usage of these services
• NHSE Programme BBV Testing dashboard reports aggregate data for monthly programme metrics; it includes number of attendances, attendances with blood tests, BBV test diagnoses, and linkage to care at site and trust level and will be used to fill in gaps where surveillance data is not available, and for data quality comparisons
• Hospital Episode Statistics (HES) contains information on hospital admissions, outpatient appointments and accident and emergency attendances and will be used for identifying late HBV and HCV diagnoses
• NHSE BlueTeq system monitoring prescribing of high-cost medicines; this data will be used to assess linkage to care for people diagnosed with HCV

Data governance and management

UKHSA policy regarding information governance where patient-identifiable information is used will be adhered to at all times, including secure storage on restricted-access project drives and use of the minimum necessary fields. Only UKHSA staff working directly on the data analysis for evaluation will have access to the relevant files and folders. Where restrictions apply to publication of data from individual datasets, suppression rules will be followed in line with the UKHSA HIV and STI data publication guidelines and the UKHSA privacy notice to mitigate risk of deductive disclosure.

Analysis and key indicators

The final evaluation report will summarise the key findings from the analysis including demographic characteristics, prevalence of new and late diagnoses, equity of the Programme and site-to-site variation; as well as making recommendations for improving the effectiveness and equity of the Programme.

Demographics and associated risks

Descriptive analysis of the demographics and social risk factors of people attending EDs, people who attend and have blood tests, those tested for BBVs and those not tested, to determine if the Programme is reaching those with specific risk factors.

Testing

To better understand the effectiveness of the Programme in testing people who have not tested elsewhere, the number and proportion of people tested in the Programme for whom this was their first recorded test will be estimated using SSBBV data.

Diagnoses

The analysis will measure the prevalence of positive results amongst those tested for each BBV, and which of these reflect new diagnoses in England, or previously made diagnoses. Late diagnoses in those who are newly diagnosed will be measured (HIV and HCV). Late diagnoses of HCV will be defined as people diagnosed with hepatocellular carcinoma, end-stage liver disease or with an F4 transient elastography score following a new hepatitis C diagnosis in EDs. Late diagnosis of HIV will be defined as adults with a CD4 count below 350 cells per mm³ of blood within 91 days of diagnosis, excluding those with evidence of recent infection (either a negative test within the 24 months prior to their first positive HIV test, or the result of the Recent Infection Testing Algorithm (RITA), which combines serological recency test results with clinical data) (see HIV Action Plan monitoring and evaluation framework 2024 report appendix 1: indicator definitions and data sources).

The number of new diagnoses that are late diagnoses will be assessed as an indicator of eligible people not having accessed testing previously. The proportion of HIV diagnoses made at a late stage of infection will be compared to those diagnosed in other settings using published data from HANDD. Instances of HCV reinfection will be measured.

Opportunities for testing

Missed opportunities for testing and diagnosis will be investigated, focusing on those who are newly diagnosed with HIV, HCV or HBV. Opportunities will be established in several ways: by linking SGSS and SSBBV to HES and ECDS to look at previous healthcare utilisation, alongside previous testing within GUMCAD; the presence of coinfections (a diagnosis of HIV, HCV or HBV for a person previously diagnosed with one of those BBVs) where testing for other BBVs could have been carried out.

Linkage and engagement in care

For HIV and HCV, engagement in care following a diagnosis in EDs will be investigated by assessing linkage to care and outcomes of treatment for those newly diagnosed, or previously diagnosed and not in care. Clinical outcomes will be assessed for those who are linked to care following an ED BBV diagnosis and compared to those diagnosed in other services.

For HIV the time taken to linkage to care will be evaluated by assessing the number and proportion of people linked within 14 days, 30 days and 90 days for those with a new HIV diagnosis and 30 days, 90 days and 1 year for those with a previous diagnosis who are not engaged in care.

The care cascade for HCV will be evaluated adjusting to allow 6 months to have passed before assessing the proportion of those diagnosed who are linked to care, and 12 months to pass before assessing those who achieved SVR.

Linkage to care for HBV cannot be monitored in surveillance data in a comparable way to HIV and HCV because there is currently no large-scale HBV dataset available to monitor HBV care. Where there is a gap in surveillance data, cross-referencing to the Programme evaluations published by participating ED sites will be undertaken where possible.

Mapping HIV prevalence validity

The prevalence of HIV amongst people identified through the ED opt-out testing programme will be compared to national and local authority level prevalence using Fingertips Public Health Profiles data.

Ethics statement

Data collected and used for this evaluation, including SSBBV, SGSS and linkage to HES/ECDS, falls under the permitted use of routinely collected data without patient consent under Section 251 of the National Health Service Act 2006 and Health Service (Control of Patient Information) Regulations 2002 (Regulation 3). Additionally, the project is designed as a service evaluation following the principles of routine data collection for providing evidence on public health interventions and as such, ethical approval is not necessary for this work.

Evaluation team

The public health evaluation team is made up of the following sections from UKHSA’s Blood Safety, Hepatitis, STI and HIV Division: Hepatitis, HIV, and Interventions Evidence and Evaluation.

Governance

The evaluation governance structure is comprised of two groups: the Operational Group responsible for providing guidance on the evaluation of the Programme and ensuring that the deliverables laid out in the Memorandum of Understanding between UKHSA and NHSE are achieved; and the Advisory Group which provides expert input and guidance to the evaluation. The Operational Group reports to the National ED BBV testing Steering Group.