Offering a new option for PrEP

Where: Grady Health System, a safety-net hospital in Atlanta.

The issue: Integrating long-acting injectable cabotegravir into a preexposure prophylaxis (PrEP) program for patients at risk for HIV infection.

Background

In 2018, Grady Health System launched an oral PrEP program that was primarily virtual, using the electronic medical record (EMR) and telephone outreach to start and maintain PrEP in patients who would benefit. The program's goal was to streamline the PrEP process and make the medications as accessible as possible, according to Dylan Baker, MBBS, FACP.

“With cabotegravir being approved in 2021, we knew we wanted to expand quickly to offer injectable PrEP within our oral PrEP programmatic structure,” said Dr. Baker, who is an assistant professor at Emory University School of Medicine in Atlanta. “We know that when you offer an extra choice for PrEP, patients are more likely to have higher uptake and high persistence. We wanted to make sure that patients had access to all available PrEP options in order to make sure that we're getting as many patients protected from HIV as possible.”

How it works

Patients interested in PrEP can refer themselves to the Grady program via its website or by phone or can be referred by their clinicians via the EMR. During an initial conversation with a patient navigator, they're asked what type of PrEP they're interested in, oral or long-acting injectable. Current program participants already taking oral PrEP can self-refer for injectable PrEP through their quarterly follow-up questionnaire or by contacting the PrEP team directly. If a patient expresses interest in injectable PrEP, program staff begin looking at financial eligibility, and when the patient meets with their clinician, they're presented with specific parameters for both oral and long-acting therapies, including costs.

“Having a different menu of options really expands our ability to meet patients where they're at and find an option that works for them,” Dr. Baker said.

For those who choose long-acting cabotegravir, patient navigators schedule the first injection visit at Grady's primary care center with an advanced practice clinician. Subsequent injections are done every two months by primary care nursing staff with assessment by an advanced practice clinician if needed. Patients complete a questionnaire about their health status in the EMR portal every four months, and the team reviews participants' clinical data weekly to determine whether adjustments to the care plans are necessary.

Participants can also switch back and forth between oral and injectable PrEP based on circumstances and preference, noted Meredith Lora, MD, an associate professor at Emory. “What we found is that in the literature and in our program, PrEP use is really highly dependent on what's happening in your life,” she said. Having a patient navigator lay out all the options “really allows people to ... actually feel like ‘I'm in control. I've got this.’ … It also allows them to really tap into what they need, instead of having to worry about all the other pieces.”

Dr. Lora also underscored the importance of informed consent, especially given that Grady is located an hour from Tuskegee and patients are well aware of the medical experimentation that took place there. “The way that you frame a long-acting medication is very important,” she said. “Including all information at the outset, being very transparent about all the benefits and very small risks, really empowers people to feel like they're making a super-informed choice.”

Results

Drs. Baker and Lora and their colleagues described their program in a paper published Feb. 11 by the Journal of General Internal Medicine. Among 221 patients referred to the program between Dec. 1, 2022, and Aug. 1, 2023, 35% started long-acting PrEP. Through Dec. 1, 2023, there were 275 injections administered, 94% on time. Six patients (8%) reported adverse effects, and eight (10%) discontinued the drug. No cases of HIV seroconversion occurred.

Dr. Baker said that there are now 250 patients actively receiving maintenance injections of long-acting cabotegravir through the program. “In general, it's really hard to find places that they're able to get injectable PrEP, so in the community, there's a lot of discussion about these options,” he said. Retention has been high, with the top two reasons for discontinuation being relocation and injection-site reactions.

“I would say in general, we have had less patients discontinue than we thought we were going to have from these types of injection-site reactions and pain at the site of injection,” Dr. Baker said. “We've been quite pleasantly surprised with, in general, how well tolerated these injections are, especially knowing that we're doing them every two months.”

Challenges

Offering injectable PrEP required some changes in organization, Dr. Baker said. “Before, we were probably over 80% virtual, with just a select few [patients] coming in for in-person intakes, so we definitely had to expand,” he explained. This involved reserving space in the clinic for staff to deliver injections, training medical assistants, and engaging nursing leadership.

The main challenge, though, was medication access. Cabotegravir is funded through medical billing, pharmacy billing, and patient assistance programs, and the three different mechanisms create an extra level of complexity, Dr. Baker said.

“Not only that, but within a large health system, we're not a free-standing clinic,” he said. “We needed to work really closely with multiple different teams within the health system in order to establish protocols and work queues to engage those teams, to secure medication authorization for a medical billing team, and that actually delayed us rolling out that funding option for our patients for over six months.”

Next steps

The Grady program has been looking at ways to decrease the time required to get patients started on long-acting PrEP, such as using point-of-care HIV tests to confirm HIV status on the day of the first injection and establishing medical access pathways in advance with payers, Dr. Lora said.

In addition, Dr. Baker noted that the FDA recently approved six-month injections with another PrEP drug, lenacapavir. “As a program, one of our focuses right now is being able to offer [lenacapavir] for our patients as soon as possible,” he said.

Lessons learned

“We were able to do this in a safety-net setting, and a large proportion of our patients who started were uninsured,” Dr. Baker said. “That's really important to our mission, to have equitable access for HIV prevention for those who might need it most. … It's a very expensive medication, but it is possible to roll it out equitably with patient assistance programs.”

A team-based structure and EMR integration were other key pieces, Dr. Lora said. “The program has a very high on-time visit adherence rate, and a lot of that comes from the intensive navigation that can build upon integrated data,” she said. “If you know right when someone misses a visit, you can act on it quickly to reschedule and maintain protection. This transparency and integrated navigation support enable scalability without an overwhelming need for manual data entry in an Excel sheet.”

Words of wisdom

Long-acting PrEP has a substantial financial benefit for health systems, so places interested in starting up a similar program shouldn't be afraid to ask for additional staff, Dr. Lora said. Two 50% FTEs, one a medication access coordinator and one a patient navigator, can be an excellent investment.

“What you get out of that investment is exponentially going to pay for the effort for that [FTE], and not only to allow the program to get off the ground, but to create a more seamless, person-centered experience for the patients who are engaging in the program,” she said.

And more long-acting PrEP programs at larger health systems are urgently needed, Dr. Baker stressed, since this option is difficult for primary care physicians to offer by themselves.

“There's so many considerations in terms of medication procurement that you'd have to have dedicated administrative support just to learn about all the options,” he said. “If I have one to two patients on my panel that would really benefit from this, most primary care physicians are going to say, ‘This is complicated. Maybe it'd be better for you to get this at a centralized clinic where they have these operations already streamlined and set up.’”

Dr. Lora pointed to a modeling study, published in July 2023 by the Journal of the International AIDS Society, that demonstrated the significant public health impact of expanding long-acting PrEP in high-risk areas.

“It's important to get people on long-acting PrEP, especially in high-incidence areas where sometimes risk is not easily predictable, and small gaps in adherence or coming on and off oral PrEP can make a big difference in seroconversion rates,” she said. “It's important to help other institutions to gain that scalability and sustainability, to really make this a big part of their prevention program.”