R01 Grant Will Fund Nationwide Study of Opt-Out HIV and Hepatitis C Testing

Dr. Hansel Tookes
Dr. Hansel Tookes (far left) with former Florida House of Representatives member Rene Plasencia, Florida State Senator Shevrin Jones and Dr. Tyler Bartholomew
Article Details
  • A Miller School of Medicine research team will use an R01 grant to study the impact of opt-out testing for HIV and hepatitis C.
  • The team, led by Dr. Hansel Tookes and Dr. Tyler Bartholomew, successfully deployed the initiative in Florida and will extend it nationwide.
  • The research team believes that opt-out testing reduces the stigma attached to HIV and hepatitis C testing and will reach the people who need it.

Despite the widespread availability of testing for HIV and hepatitis C virus (HCV) infection at Syringe Service Programs (SSPs), a minority of people who inject drugs choose to get tested in these settings.

Researchers at the University of Miami Miller School of Medicine want to change that.

After successfully implementing opt-out testing in Miami, a team led by Hansel Tookes, M.D. ’14, M.P.H. ‘09, and Tyler Bartholomew, Ph.D., designed the ACCESS implementation strategy. The multiphase, multicomponent structural intervention provides implementation support to SSPs for opt-out testing.

After a successful pilot phase across all SSPs in Florida, they are now studying the difference it could make nationwide.

With opt-out testing, HIV and HCV testing is offered in a destigmatizing way. Many SSPs don’t offer opt-out testing due to a lack of funding, training and organizational capacity. By addressing barriers to implementation, researchers argue these organizations can successfully adopt, implement and sustain opt-out initiatives and better serve people who need to be tested.

Dr. Hansel Tookes in front of an IDEA Exchange vehicle
Dr. Tookes says opt-out approaches can improve HIV and hepatitis C testing access for people who need it.

“We’re really, really excited,” said Dr. Tookes, professor of medicine in the Division of Infectious Diseases at the Miller School and medical director of the IDEA Exchange. “It’s critical to increase the reach to this community that has increased risk for both HIV and HCV acquisition.”

Through an innovative proposal, Dr. Tookes and Dr. Bartholomew, assistant professor of public health sciences, received a $3.3 million R01 grant from the National Institute on Drug Abuse to support this five-year ACCESS initiative. In addition, a $2 million Front Lines of Communities in the United States (FOCUS) award from Gilead Sciences, Inc., will directly support opt-out screening and linkage to care at the SSPs.

The researchers will randomly assign 32 SSPs to implement either opt-out testing or standard testing. They hypothesize that the opt-out approach will boost testing rates beyond the national average of 15% at SSPs.

They have reason to be confident. When the IDEA Exchange implemented opt-out testing in 2018, more than 90% of clients learned their HIV and HCV status. Dr. Tookes and Dr. Bartholomew had identified an HIV and HCV outbreak and worked with the Florida Department of Health and the Centers for Disease Control and Prevention to limit transmission.

Dr. Tyler Bartholomew
Dr. Tyler Bartholomew

The initiative will send a team of people with lived experience to coach SSP staff on how to optimize opt-out testing for their setting.

When people who inject drugs enroll in services with opt-out testing, they are told HIV and HCV screening is a routine part of the program. They have a right to decline. The program also links people who test positive for HIV and/or HCV to appropriate care.

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

Opt-out testing offers another potential advantage. It helps to destigmatize infectious disease testing. If nearly everyone gets tested, people may not feel they are being singled out based on age, risk status, race or any other factors.

The CDC, which publishes a prestigious HIV compendium, already added the opt-out testing strategy, based on the success in Florida.

“We were 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,” Dr. Bartholomew said.

Team Science Pays Off

Dr. Bartholomew first suggested FOCUS funding as a public-private partnership with Gilead when he was “a very eager graduate student,” Dr. Tookes said.

Dr. Tookes was hesitant at first. He was focusing on growing the IDEA Exchange and needed the community’s trust.

“I said, ‘Let’s apply for a Gilead FOCUS award to implement routine screening and linkage to care at IDEA,’” Dr. Bartholomew said.

They were awarded their first FOCUS award in February 2018. Dr. Tookes’ and Dr. Bartholomew’s complementary expertise forms an ideal partnership.

“We really take a team science approach to the work that we do,” Dr. Bartholomew said. “Hansel is a physician and HIV clinical trialist and I am a prevention and implementation scientist. We have completely different yet complementary skill sets that synergize around one common mission: improving the health and saving the lives of people who use drugs.”

“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.”

When IDEA uncovered an HIV/HCV outbreak within weeks of operationalizing FOCUS, Escobar was concerned for Dr. Tookes and Dr. Bartholomew.

“Imagine the pressure that they were under as a pilot program. The entire state was relying on their success,” Escobar said. “But they did it. They made it a public health success story.”

That led to expansion of SSP legislation. The collaborative partnership under Dr. Bartholomew’s leadership has led to FOCUS arrangements at seven SSPs in Florida.

“The partnership between Gilead’s FOCUS program and the IDEA Exchange is an amazing demonstration of public-private partnership,” said Derek Spencer, FOCUS executive director. “These are needed collaborations where people are coming together with innovation to solve problems. These public-private partnerships are needed to help end the epidemics of HIV and hepatitis C for everyone, everywhere.”

The backing from the Miller School makes projects like this possible.

“We have support from leadership, from the Dean, to be doing these types of initiatives,” Dr. Bartholomew said. “To be creative, to be innovative and to push that needle forward that’s going to lead to population impact.”

The interdisciplinary environment at the Miller School works well, too.

“The ability to have public health professionals like myself alongside medical professionals thinking of how we can better serve communities leads to real-world change,” Dr. Bartholomew said. “We really want to show that providing low-barrier, tailored funding and implementation support is the most effective and best way to have SSPs implement best practices. Then 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.”

Through their transformational tele-harm reduction trials for HIV treatment and prevention, along with ACCESS, “we hope that we are going to set a new standard of care for comprehensive HIV services,” Dr. Tookes said.

Tags: Dr. Hansel Tookes, Dr. Tyler Bartholomew, hepatitis C, HIV, IDEA Exchange