NIDA Grant Awarded to Researchers to Identify Best Practices to Boost PrEP Adherence

An international collaboration among researchers in Miami, New York, and Montreal aims to determine the best strategies for effectively providing people who inject drugs with pre-exposure prophylaxis (PrEP) to protect them from HIV infection. Their efforts will be backed by an $8 million grant just awarded from the National Institute on Drug Abuse.

From left, Michael A. Kolber, M.D., Ph.D., Hansel Tookes, M.D., M.P.H., and Daniel J. Feaster, Ph.D.

“Generally just telling people about a place they can go does not work, so we’re using a patient navigation approach and comparing this to directly providing care in venues that provide services to people who inject drugs,” said Daniel J. Feaster, Ph.D., associate professor of public health sciences at the University of Miami Miller School of Medicine. “We are very happy. Getting this grant on the first round was a nice surprise.”

Feaster is joined by Lisa Metsch, Ph.D., chair and Stephen Smith professor of sociomedical sciences at Columbia University’s Mailman School of Public Health, and formerly a Miller School faculty member, and Julie Bruneau, M.D., professor of family medicine and emergency medicine at the University of Montreal, as the principal investigators of the project. In Miami, Feaster is joined by a team of top infectious disease experts with the Miller School and UHealth – the University of Miami Health System.

Pre-exposure prophylaxis is an increasingly popular strategy to prevent infection among people who are HIV-negative.
“It’s been predominantly aimed at men who have sex with men,” said Feaster. “There was a study done in Thailand that showed it does work for people who inject drugs, but there has been very, very little research in the United States or North America in general.”

“The CDC says that people who inject drugs should be allowed to go on PrEP, but we really don’t know what’s going to happen when they do,” said Feaster. “They specifically want to learn if the setting is important. Should the therapy be provided at an opioid substitution center or needle exchange setting, or both? Is this on-site approach preferable to actively referring people off site for care? Which strategy is most cost effective? And how much do people who inject drugs know about PrEP, and how receptive will they be?”

Feaster said providing services on site also adds cost, but from a public health perspective, it may cost less overall in terms of HIV prevention. In fact, Bruce Schackman, Ph.D., M.B.A., professor of health care policy and research at Weill Cornell Medical College in New York, and Bohdan Nosyk, Ph.D., associate professor of health sciences at Simon Fraser University in Vancouver, B.C., will compare the economics of on-site care versus patient navigated referrals and explore the economic impact of expanding these interventions more generally.

The NIDA-funded research will fill a gap in current knowledge, said Michael A. Kolber, M.D., Ph.D., a top UHealth infectious disease physician, director of the Comprehensive AIDS Program, director of Adult HIV Services, and Miller School professor of medicine.

“There are not enough data to determine what will improve uptake and consistent usage,” he said. “It is not clear what strategies will work with this population since we still have challenges with certain populations in taking a medication when you are not ill.”

He added, “There is a mixed feeling whether people who inject drugs will take the medication consistently and whether the intervention will be cost effective, ergo the study.”

Participants will be randomized to on-site or patient-navigator-facilitated linkage to care. On-site services will be offered in Montreal and Miami. The IDEA (Infectious Disease Elimination Act) Exchange needle exchange clinic and Comprehensive Psychiatric Center (a local methadone maintenance clinic) will both host the program locally.

“The IDEA Exchange is ideal because only 9 percent of the participants have HIV. That means we have the opportunity to prevent HIV in 91 percent of this high-risk population,” said Hansel Tookes, M.D., M.P.H., founder of the needle exchange clinic and assistant professor of clinical medicine in the Division of Infectious Diseases at the Miller School.

“An integrated, one-stop shop meeting the people who inject drugs where they are should allow us to provide yet another tool our participants can use to improve their health outcomes,” Tookes said.

The NIDA grant also will include hepatitis C treatment in this population.

“And while HCV is treatable, it’s very expensive to treat,” Feaster said.

Curing HCV as part of this program, and helping people avoid subsequent re-infection, would not only improve individual outcomes but could save money overall.

“The opportunity to treat hepatitis C in our participants — 50 percent are infected — is an exciting prospect that I hope will be effective and replicated around the country,” said Tookes.

Other investigators on the study team include Allan E. Rodriguez, M.D., professor of clinical medicine in the Division of Infectious Diseases at the Miller School; Valerie Martel-Laferriere, M.D., M.Sc., assistant clinical professor in the Department of Microbiology, Infectiology and Immunology at the University of Montreal; Marie Goyer, M.D., M.Sc., associate professor in the Department of Family Medicine and Emergency Medicine at the University of Montreal; Elise Roy, M.D., of the Faculty of Medicine and Health Sciences at the University of Sherbrooke; and Roberto Ruiz, M.D., a psychiatrist at the Comprehensive Psychiatric Center in Miami.

“The University of Miami is ideal for a study like this,” Feaster said. “For one, we are running the only needle exchange in Florida. Secondly, the prevalence of HIV infection in Miami ranks among the highest in the nation, and we need programs to address that. A growing opioid problem only adds another challenge.”

The NIDA-funded program will add to the essential services offered at the IDEA Exchange and further strengthen its value to the community, Feaster added.

“We are fortunate to have a syringe exchange program within our academic institution, and this study is the perfect example of how IDEA will lead the way in improving harm reduction practice nationwide,” said Tookes.

“I believe the study will show that onsite care will get more people treated,” Feaster said. “We also need to know how this population is going to react to PrEP. I also hope it will show that PrEP is a reasonable strategy to prevent HIV infection in people who inject drugs.”

This study is ongoing and is scheduled to run through July of 2022.

Tags: AIDS, Hansel Tookes, HIV, Joseph Feaster, Michael Kolber, Miller School of Medicine, needle exchange, PrEP, University of Miami