HIV: Putting screening to the TEST

This website has been created by Gilead for the purposes of disease education and awareness.

Despite making fewer headlines than in previous decades, the HIV epidemic in Europe is far from being a thing of the past. It will still be around to taunt us, as we learn to cope with yet another deadly virus.

The COVID-19 pandemic had a significant impact on HIV screening and diagnosis. After a significant drop in new diagnoses during the years of lockdown, the number of new infections increases again in the EU/EEA.1

In 2021, over 16,000 newly diagnosed HIV infections were reported in the EU2. One in two people were diagnosed at a late stage of infection. Late HIV diagnosis is problematic not just to the individual, who experiences increased morbidity and mortality, but to society as a whole, with missed opportunities to break transmission in a highly infectious stage of disease. The highest proportions of people diagnosed at a later stage of infection were among men and women infected by heterosexual sex (69% and 56%, respectively)3.

In countries with concentrated epidemics, people in stable relationships are perceived to be at low risk and may not consider themselves at risk, thus do not seek voluntary testing. If infected, they are likely to be diagnosed with advanced HIV infection. In 2018, Public Health England reported that only 12% of sexual health services had been able to meet a standard of testing 80% of all eligible attendees, with much lower coverage among heterosexual men and women than among gay and bisexual men.

Scientific advances in testing technology have all but spoiled us. Generation Z, who witnessed how the world developed new tests (plural) for SARS-COV-2 in just a matter of days, would likely struggle to understand that the first tests to detect HIV were developed only in 1985, years after the virus was discovered. It would be a further 17 years until rapid HIV diagnostic test kits could provide results within 20 minutes, and 12 more years until point-of-care technology could yield confirmatory molecular test results within an hour. With many currently rushing to seek testing to know their status regarding the coronavirus, why don’t we see the same behavior regarding HIV?

Screening is a tool for the elimination of these viruses; it is the cornerstone of secondary prevention, which reduces the prevalence of existing disease at its earliest stage, preventing further transmission. We know this. We have the technology and the resources to do it. Why then are we failing to screen eligible individuals? Why are infections among heterosexuals and migrants on the rise in some countries? Are current targeted screening approaches enough to crush the HIV curve once and for all?


A new hope from across the sea

To date, screening for blood-borne viruses (BBV) like HIV, HCV, and HBV has mostly followed traditional models — a process that remains separate from normal clinical practice and that requires additional dedicated staff and resources. Instead of integrating screening into the regular provision of care for all eligible patients, the traditional approach relies on case-by-case decision, which may also reinforce the deterring stigma associated with testing for these infections.

Gilead Sciences developed the FOCUS (Frontlines of Communities in the United States) program4, a public health initiative, to enable FOCUS partners to develop and share best practices in BBV screening, diagnosis, and linkage to care in accordance with screening guidelines recommended by national, state and local public health authorities. FOCUS funding supports HIV, HCV, and HBV screening and linkage to a first medical appointment. FOCUS partners do not use FOCUS awards for activities beyond linkage to a first medical appointment.

The guiding model of the FOCUS program is based on the premise that testing is integrated into the normal clinical flow, using existing clinical infrastructure and staff to create efficiencies. FOCUS partners may modify their electronic health record system to streamline screening processes, implement systemic institutional policy change, and engage in continuous quality improvement.

FOCUS partners establish screening and linkage to care infrastructures to support individual and public health. Since 2018, EU FOCUS partners include hospitals, community health centers, community-based organizations, and other public health organizations that advance screening, diagnosis and link individuals to care. Partner organizations then share their learnings and project data with national and regional governments.

Partnerships between FOCUS, healthcare organizations, and governments have enabled EU FOCUS partners to implement screening in alignment with ECDC, national and regional public health authorities’ guidelines, and develop and share best practices. EU FOCUS partners have performed over 190,000 tests under the new framework of an “opportunistic” testing approach.

The idea is to make the most of the general population’s visits to medical facilities and offer eligible individuals testing while they are there. In practice, it means simultaneously testing for HIV whilst blood work is processed for other reasons. This opportunistic approach reduces deterring biases, while respecting the patients’ right to decline, as they would with other common clinical investigations such as measuring cholesterol levels.

Next generation screening

From Portugal’s pioneering drug use decriminalization laws, to Spain’s robust response to eliminating Hepatitis C, some of this century’s most significant advances in public health have originated in the Iberian Peninsula.

FOCUS partners in both these countries are no exception. Located 30 minutes west of Lisbon, Hospital de Cascais was the first EU FOCUS partner. Since September 2018, the hospital has used its electronic health record system to automatically add serologies for HIV and HCV for patients aged 18 to 65 who visited its emergency department and required a blood draw for any reason — a direct response to the European Centre for Disease Prevention and Control’s (ECDC) 2018 integrated testing guidelines.

The majority of patients diagnosed acquired the infection through heterosexual sex, and many had never sought HIV testing before being offered screening in Cascais. Dr. Inês Vaz Pinto, the project’s principal investigator, is clear on how it is revolutionizing screening and linkage to care in the hospital. “We set out to make screening available to more patients in the Emergency Department, and we did. We had also set out to diagnose patients earlier on.” She continues, “Before the FOCUS project, 90% of our patients were diagnosed late . Under the FOCUS project, late diagnosis fell to 43%. By any measure, we have met our goals”.

Dr. Vaz Pinto points to other metrics, such as patients’ countries of birth. “Whereas before the ratio of foreign-born to Portuguese patients diagnosed was 1:1, under the FOCUS project, that ratio changed to 2:1.” By implementing ECDC’s 2018 integrated screening guidelines, Dr. Inês continues, “We’re diagnosing new infections in many migrant citizens who were previously leaving the hospital unaware of their status — most hail from the Portuguese diaspora of Brazil, Guinea, and Cape Verde. Now we’re independently going to look at our data to characterize missed opportunities at our hospital before FOCUS. How many of these patients had visited us in the previous 1 or 2 years without being offered a test?”.

On the other side of the peninsula, the staff at València’s Hospital General Universitario know the answer. Among patients screened using an opportunistic methodology, 18% originated from Sub-Saharan Africa, Pakistan, South America, and Romania, with higher disease burden in these groups. They would likely have gone for years unaware of their status. Not anymore.

Hospital General is one of a brave few pioneer institutions in València, Barcelona, Galicia, Andalusia, Madrid, and others in Spain who have realized that the traditional ways of screening did not allow them to offer screening to eligible individuals as they had hoped for their population. While the FOCUS model for opportunistic screening may not be a one-size-fits-all solution, it is definitely a useful weapon in the fight to reduce undiagnosed HIV and stop the virus.