HCV, HIV opt-out testing program to now be evaluated nationwide

Individuals in Syringe Service Programs would have right to decline testing

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by Steve Bryson, PhD |

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A team of researchers, backed by a grant totaling more than $3 million, will study the feasibility of a nationwide opt-out testing program to detect hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infections at Syringe Service Programs, which distribute sterile syringes and safer supplies to people who inject drugs.

With opt-out testing, individuals enrolling in Syringe Service Programs, or SSPs, are informed that virus screening is a routine part of the program, but have a right to decline, or opt out.

The ultimate goal is to prevent the spread of HCV and HIV infections, and if almost everyone undergoes testing, individuals may not feel singled out due to age, race, risk status, or other factors, according to the researchers. In addition, the program provides access to appropriate care for those testing positive for HCV and/or HIV.

“We’re really, really excited,” Hansel Tookes, MD, professor of clinical medicine in the division of infectious diseases at the University of Miami’s Miller School of Medicine, in Florida, said in a university press release.

“It’s critical to increase the reach to this community [of injectable drug users] that has increased risk for both HIV and HCV acquisition,” said Tookes, who also serves as the medical director of the Infectious Disease Elimination Act, or IDEA Exchange, which aims to limit the spread of hepatitis C and HIV via harm reduction.

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The hepatitis C virus, known simply as HCV, is spread via contact with infected blood or other bodily fluids, most commonly by sharing needles to inject drugs or from contact with contaminated medical equipment.

While some people clear the virus quickly, most develop a chronic infection with ongoing liver inflammation. Over time, about 1 in 4 people with chronic HCV will develop irreversible liver scarring, or cirrhosis, data have shown.

A team led by Tookes and Tyler Bartholomew, PhD, an assistant professor of public health sciences at Miller, successfully launched an opt-out testing program in Miami several years ago. They then designed the ACCESS implementation strategy, a multiphase structural intervention that supports SSPs in enacting opt-out testing.

After a successful pilot program across all SSPs in Florida, Tookes and Bartholomew now want to assess the potential benefits of such programs when implemented nationwide. The new five-year ACCESS initiative is supported by a $3.3 million grant from the National Institute on Drug Abuse, part of the National Institutes of Health.

A $2 million Front Lines of Communities in the United States (FOCUS) award from Gilead Sciences is also supporting direct opt-out screening and access to care at the SSPs.

“After meeting with Dr. Bartholomew and visiting IDEA, we knew that it was important to partner with them and to help them implement opt-out screening and linkage to care,” said Jackie Escobar, FOCUS’ senior regional director. “Something that Dr. Tookes has taught us is that harm reduction must reach the population of folks that have been left behind. They’re often left out of health systems.”

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In the new study, researchers will randomly assign 32 SSPs to either opt-out or standard testing to determine if the opt-out approach will boost testing rates beyond the national average of 15%. SSP staff will be coached on optimizing opt-out testing by a team of people with lived experience.

“We encounter a lot of people who are in need of compassionate and culturally competent care,” Tookes said.

Tookes and Bartholomew are confident of the program’s success: More than 90% of SSP clients learned their HCV and HIV status when the IDEA Exchange began opt-out testing in 2018.

As a result, the researchers identified an HCV/HIV outbreak and worked with the Florida Department of Health and the Centers for Disease Control and Prevention (CDC) to reduce viral transmission.

That public health success story triggered the expansion of SSP legislation and the implementation of FOCUS programs at seven SSPs in Florida, the release stated.

We encounter a lot of people who are in need of compassionate and culturally competent care.

“The partnership between Gilead’s FOCUS program and the IDEA Exchange is an amazing demonstration of public-private partnership,” said Derek Spencer, executive director of FOCUS. Such partnerships “are needed help end the epidemics of HIV and hepatitis C for everyone, everywhere.”

Based on the success of the opt-out testing program in Florida, the CDC also has made this type of approach part of its HIV compendium, a collection of evidence-based interventions and best practices to prevent HIV.

According to Bartholomew, the program was “added to that compendium as the only structural intervention focused on SSPs and the only intervention to show an increase in HIV testing uptake among people who inject drugs.”

For the nationwide HCV/HIV opt-out testing program, “the next step is to go to federal partners and other agencies that will provide sustainable funding to SSPs to implement best practices moving forward,” Bartholomew said.