Moti Ramgopal, MD, FACP, FIDSA

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I think some of the most important population health opportunities for PrEP [pre-exposure prophylaxis] are thinking about ways to streamline this process for both patients and clinicians. If PrEP is as easy as 1, 2, 3, I think that would make a huge difference. We need to work on many other things, such as knowledge of PrEP, stigma in health care and community settings, cost. But if we make it easy as possible for people to access, then I think we may hit the tipping point where it becomes more widely disseminated and used.

I think the system for paying for PrEP is very complicated. If people have insurance, it’s still very complicated in terms of which formulations are on formulary. How much of a co-pay is there? There shouldn’t be a co-pay because there’s a USPSTF [US Preventive Services Task Force] grade A recommendation for PrEP, but sometimes there are prior authorizations. So we have these things called PrEP navigators to help people get onto PrEP in an affordable manner.

If you take a step back, it’s kind of crazy that we need navigators to get people from A to Z for something as straightforward as PrEP. It’s really not that complicated of a medical intervention once you think about it. It’s almost like a see one, do one, and teach one in terms of medicine. For oral PrEP, it’s usually a daily pill or maybe an intermittent regimen, which is relatively straightforward. For injectable PrEP, it will be injections every 2 months after people are on a sustained regimen. I think we just need to make this as simple as possible.

Some colleagues who are health policy experts have proposed a way to have the federal government purchase and disseminate PrEP in a centralized manner. I think this offers a really exciting potential way to make PrEP much simpler for everyone who comes into the clinic, knowing they can access it at low, or no cost ideally, in terms of the medications, the laboratory testing, the clinical fees for physicians, etc. If we lower the bar in terms of barriers to accessing PrEP, that can only help because right now, if we think about how you need to have a navigator to get you onto PrEP, we need to simplify things.

I also think in terms of the CDC [Centers for Disease Control and Prevention] recommendations for PrEP, which are very well thought out, for oral PrEP, and then in the future, long-acting injectable PrEP, which have slightly different follow-up plans, it does end up being a relatively complex care plan to implement for a clinician in a health care system. You have to think about what agent someone is on, what the follow-up schedule is, have they had labs in the recommended amount of time? Have they had additional testing for sexually transmitted infections, have they had adherence counseling?

If there are ways we can use evidence to show that people can safely use PrEP with less access to the clinic, fewer visits, less lab monitoring when it’s safe, then I think those will be ways to improve PrEP as well. That can also dovetail and synergize with telemedicine approaches to PrEP. In the future, any way we can de-medicalize PrEP and engage communities on a broader scale, I think will increase the impact and effectiveness of the intervention.

 I do believe when you look at 1.8 million new cases a year around the world, the access beyond America is very important. There are 34 million people with HIV in the world today, and roughly 1.2 million in the United States, so 30-something million people around the world, and there are new infections every single day. I think ultimately, we really need to move this from the United States to the rest of the world. We need to make PrEP cheaper, available, and get it into places where the risk is high. We need to identify the hot zones, so to speak, the high-risk areas or communities around the country, around the world, and really focus our attention into these areas and sacrifice financial gains ultimately for what’s better in the long term for community and humanity.

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The benefits of addressing barriers and increasing access to HIV PrEP therapies to high-risk populations across the globe.

Opportunities for HIV PrEP in Population Health

I’m involved in clinical research, and it’s always fascinating and exciting to be involved in projects that you won’t hear about for another year to 2 years from now, but we are moving quite rapidly into the PrEP [pre-exposure prophylaxis] world. Prior to this conversation, we have Truvada, we have Descovy, and we’ll have an injectable PrEP pretty soon. This will be an injection every 2 months for PrEP. Apart from that, what’s also in the pipeline? We’ll have probably weekly pills, monthly pills, 6-monthly injections of PrEP, PrEP implants. And then for women, there are also going to be intravaginal rings for PrEP.

There are a lot of these agents, so to speak, or new modules of treatment or new medications involving treatment that will be rolling out soon. I think this is going to be good because a lot of time people will start PrEP, stop PrEP. If you have an injectable PrEP that stays in your system up to 2 months, you get a shot today, 2 months there or even longer, and you have a 6-month PrEP, I really do believe these new agents will be game changers. It’s not about taking a pill every day anymore. It’s about knowing full well that you’re protected against HIV by having an injectable agent in your system. That’s going to protect you for several months at a time.

Once we get there, I really truly believe once the access issues have been addressed, once we recognize—of course, you’re going to hear, “Well, you’re implanting some slow-release product.” That could be a challenge because we’ve seen the challenge with COVID-19 vaccines, or even if you give an injection. But I do believe that the patients involved in HIV care, what I’ve seen is that they’re more in tune with understanding medical care and what’s developing. They’re looking forward to these new strategies. And again, just to remind you what these strategies are, long-acting pills once a week, or probably once a month, long-acting injections every 2 months, probably every 6 months, vaginal rings, and implants that can stay in your system for quite a while.

As far as the long-acting agents in the pipeline and the potential barriers and logistical concerns surrounding those products, I’m not sure that there’s a huge worry as far as logistical concerns. When you have medical benefit provider–administered products, that does introduce logistical issues because those products need to be shipped to the provider’s office versus being picked up from the pharmacy or being shipped to the member’s home. There are some considerations there, but I think as a health care system, we’ve ironed that out. But it is more complicated than taking a prescription to the pharmacy. With the long-acting agents that may be self-administered, I think there are fewer logistical issues. The worry then is, it’s not a daily administration, potentially, therefore adherence becomes more of an issue because if you miss your dose, whether weekly or monthly, it becomes a bigger issue than if you miss just 1 day. I think those are the logistical concerns, but I don’t think either of those are insurmountable. I think having options that are long-acting that provide better options for adherence are going to be a boon for the patients and for the HIV PrEP community.

For how we overcome the challenges with the medical benefit, the logistical concerns from a provider perspective, I think over time, the introduction of specialty pharmacies into this buy-and-bill medical adjudication, distribution perspective has helped. It used to be that if providers were going to administer something, it had to be buy-and-bill. Sometimes providers don’t want to get involved in having overhead and the complicated aspects there, but now with specialty pharmacies being able to be involved, bill medically, and then ship the product to the provider office, I think that has helped. The PrEP therapy would come from the specialty pharmacy with the patient’s name on it, and it says, OK, this is here for patient A when patient A comes in to get their administration. I think that prevents them from having the overhead of stocking these things. That’s been one helpful tool, because that was one of the big barriers, that not every provider wanted to go through that.

An overview of HIV PrEP therapies in the pipeline and their potential roles as they are introduced into the community for use among high-risk populations.

Developments in HIV Prophylaxis: New PrEP Options

 We really need to think about ways to improve access to PrEP [pre-exposure prophylaxis] across all populations, especially in populations where HIV risk is highest and access to PrEP has been lowest. In terms of general access to PrEP, 1 thing my colleagues and I have advocated for is a routine conversation about PrEP. CDC [Centers for Disease Control and Prevention] guidelines, which were just updated for PrEP, emphasized the approach that clinicians should discuss PrEP with every sexually active adolescent and adult in America. The previous guidelines said that it should be discussed with people who may be at increased risk for HIV. But they did the right thing by broadening this, saying that clinicians should make this a routine part of primary care and that it should be integrated just as we ask people about family planning, seatbelts, and tobacco and alcohol use.

This is a piece of well-being that we need to integrate into routine health care. If we do that, then many more people will learn about PrEP just from being asked if they’ve heard of it and if they’re interested in it. Even if people say it’s not for them, they’ll learn about it. Maybe they’ll talk to their peers, family, and friends about it. That’s 1 way to do it—making PrEP conversations routine. With CDC guidelines endorsing that, health care organizations need to think about ways to do this.

In terms of other ways to improve access to PrEP, we need to meet people where they’re at. For some people who have psychosocial challenges to accessing health care and maintaining healthy behaviors, getting outside the traditional clinical setting is important. Whether it’s embedding PrEP in sterile syringe programs for people who inject drugs or working with programs that provide health care to people who have marginalized housing. That’s a great model. Some people don’t have stable housing but are willing to engage with health care programs. We have some excellent ones in Boston. For example, the Health Care for the Homeless Program has developed tremendous expertise at delivering general health care. Also, we have PrEP care for people who may not have stable housing. For populations that have mental health conditions—depression, anxiety, PTSD [post-traumatic stress disorder]—that get in the way of accessing health care and adhering to PrEP medication, we need to think very broadly about ways to engage clinical psychologists and nurses and the whole health care team to help people treat their behavioral health challenges and get them access to PrEP.

In the future, hopefully there will be more PrEP options, given that long-acting injectable agents are under FDA review and might be available as early as the first quarter of 2022. We need to think about using those options to engage new populations that have underused PrEP thus far. For people injecting drugs and coming to sterile syringe programs, if they’re coming frequently to a program like that, that’s a great time to offer people PrEP.

I was with a colleague recently who has been administering Suboxone methadone as part of a program and is eager to layer in PrEP. They’ve done it successfully with oral PrEP. When there are longer-acting options, it will be a nice synergy for certain populations.

The same will be true for other populations that have trouble accessing health care and taking a daily pill. For example, adolescents and young adults who have busy lives and are still developing in terms of social and brain development, taking a pill—if you’re otherwise healthy—might be a new phenomenon for them. [We need to] think about ways to improve access by engaging pediatricians, adolescent medicine specialists, and college health clinics and using oral and, hopefully in the future, long-acting options for people who are younger and getting introduced to a new idea of taking a pill or getting injection. All those will be ways to engage important populations in PrEP. I’m very optimistic that the future holds ways to improve PrEP on a population level if we think intelligently and intentionally about accessing these populations.

 The disparities and inequities of access have a lot to do with stigma. It has to do a lot with insurance providing treatments and coverage for PrEP. What we do as an organization or a clinic is to try to go to those communities where we think there will be high risk. We have partnerships with MSM [men who have sex with men] groups. We have partnership with a lot of local groups that have that peer support and navigation tools. We partner significantly with groups that can advise patients and bring them into care. The question is also, here’s an African American or Latinx person, they’ll feel as though, “I don’t need it for A, B, and C reasons.” How do we get that person to understand and break that inequity challenge? They’re uninsured. How can we get that person into believing that even though you’re uninsured, you can still be in PrEP because we have patient-assistance programs.

In terms of disparities and inequalities in access to PrEP, we need to access all the tools we’ve discussed. We need to invest resources in the communities and places in the United States that have been slower to have PrEP uptake. The CDC and the federal government have the Ending the HIV Epidemic initiative, which emphasizes investing our prevention resources most aggressively in 48 hot spot counties and 7 rural states. Their goal is to end the HIV epidemic by decreasing new infections by 90% by 2030.

That’s a good way to look at this from the start: where are the HIV infections happening most frequently, and where is PrEP use lowest? Those hot spot areas are a good place to look. We also need to think about racial and ethnic inequities. There’s been a long history of racism in health care and discrimination against Black and Latinx populations. We need to engage clinicians, organizations, and patients in a new conversation about making health care welcoming and inclusive, an environment where everyone can feel like they’re going to get effective and personalized health care. This is also true for people who may be transgender or nonbinary in terms of their gender identity, who have faced health care discrimination and societal discrimination for a long time. We need to get the health care system to be as welcoming and inclusive as possible.

If we do that, then hopefully communities where PrEP has been underutilized will see this as something that is a feasible, acceptable, and attractive thing that people are motivated to use. Then it benefits the patients and the health care system as well for all the reasons we’ve discussed in terms of the economic and population public health impact of HIV in the United States.

Strategies that can help address disparities in care for patients with HIV and reach high-risk groups of patients to ensure access to screening and PrEP. 

Addressing Disparities and Increasing Access to HIV PrEP

 Multidisciplinary management for a patient on PrEP [pre-exposure prophylaxis] is very critical. Just as we do with HIV, we look at what that patient, as an individual, requires. Some patients may be fine with their medication. Some patients may be fine with their mental health issues. I also have what we call a peer navigator—someone who’s on PrEP who also can speak to that patient with difficulties of accessing PrEP or who say, “I’m tired of taking a pill.”

This is where we use the team approach. We look at patients who are not in care; for example, they missed an appointment. We send them a ping on their phone with their appointment follow-up. What’s the reason for the missed appointment? We try to get ahead of it instead of waiting. The initial patient assessment is important. We need to understand the patient and why they’re going to PrEP, making education a big piece of this. We need to recognize patients who don’t come in may have stigma concerns, as I mentioned. They have fears. What are the infection rates? What are their friends doing? It’s important to address all these concerns very early.

The pharmacist’s role is make sure they can get a patient system program certified, looking at their income and the other challenges they’re facing. The social worker can also bring that into the game. As a provider, when I meet a patient for the first time, I try to understand their need. I assess that patient and try to find the challenges that are going to make them fail treatment down the road. Is it going to be compliance? Is it going to be stigma? Is it going to be recognizing the lack of comfort in the clinic? They’re not comfortable coming back for medication? They’re not comfortable speaking to the provider? These are the challenges we have to identify very early.

The team-based program provides several benefits because it allows the patient to see that it’s not 1 person involved in their care but many layers of management. There are many layers of interest in what’s going on in their life, with their risk behavior and other factors. Imagine going into a room and you have 1 provider. Then somebody comes in with a different personality and energizes the room in a different way. Everyone has a different part in the conversation—the peer navigator, the pharmacist, the social worker. Everyone will create that environment so the patient will feel comfortable, recognizing that this isn’t a game. This is a serious project.

It’s a project in which we need to reduce as many new HIV infections as possible. I look at my community in St. Lucie County, Florida. I look at how many people are on PrEP and how many aren’t. Every time a patient presents with HIV, I say, “Who’s your partner? Is your partner positive or negative? What’s the high-risk relationship? How can we get your partner into care on PrEP?” We’re seeing a lot of social behavioral changes during COVID-19. Promiscuity is increasing. There’s a lot of group behavior that we’re beginning to recognize in our patient base—they may go away for weekends as a group and go to a different part of the state.

These are patients we reach out to when we talk about getting people into care. We reach out to these patients and say, “Bring your partner in. Bring your friends in. Let’s get them on PrEP. Here’s team support. We have mental health support. We have a substance abuse counselor. We have a pharmacist.” They will probably understand how to connect with these patients. As a physician in my mid-50s, I don’t understand a lot of these behaviors.

That’s why it’s important to have younger people on the team who can converse with our patients, especially at checkout. A younger person at checkout can understand these patients and their questions. It creates a level of comfort for these patients when they come into the clinic.

The advantages of coordinated care between multiple health care providers when managing patients on HIV PrEP therapy.

HIV PrEP and Multidisciplinary Care

: How do we evaluate PrEP [pre-exposure prophylaxis] walkaway rates? That’s a good question. It’s a consideration that we’re looking at. How do we do it, and are we doing it? Those are 2 different questions. We have the ability to look into pharmacy claims and say, OK, here are the prescriptions for people who have filled them but are not continuing to fill, and so we could say that would be a walkaway. We would look at pharmacy claims to do that. Do we have an active process to react to that information? That is the next step. Do we have a team to reach out and have those conversations? There are people in the plan who could do that. We do not have an organized program at this point to engage with patients around PrEP walkaway.

: The technology now, we have texts we can send to patients when they have auto care. My pharmacist will text them and say, “You didn’t pick up your medications. How can you get that?” Communication by email—educational email, not personal data by email—but mainly communication by a phone, cell phone. We communicate through different sites, for example, when you have a patient in care, we use a lot of the social media sites to get them into care. But now retaining them in care is a lot about information. It’s a lot about telling them if you’re out of care, what’s going to happen.

I just had a patient recently because of substance abuse, he fell out of care, so we had to address his substance abuse issues first, address the mental health issues related, then get him back into care. But it’s important that there’s a formula here every 3 months, every 6 months. If you’re not seen in 3 months, you have to call the person and say, “Hey, you missed your pill. How can we get you back into care? What is missing?” And a lot of times you hear, “Well, I’m not as sexually active as before. I don’t think about the high risk as before. I stopped taking medication, or I stopped taking my PrEP. I’m out of a relationship.” And then 3 months later, that person will come back into care.

I think it’s important that patients realize or recognize that even if they’re out of care, the door is still open to jump back into care very quickly. Because we still look at other things, it’s not just about PrEP alone. It’s about checking for STDs [sexually transmitted diseases], check for chlamydia, check for syphilis. It’s a whole program that we work with our patients with, recognizing that HIV alone, you have coinfections related to that as well. It’s important to recognize that patient adherence [can come and go]; we see a lot of dropouts. And sometimes we see the dropouts now because of insurance issues. They can’t fill their medications anymore, they’ve lost their insurance. We have a patient assistance program we work with to get them, if you’re out of your insurance, we can jump quickly into the patient assistance program to get you back into PrEP.

Discussion regarding HIV PrEP walkaway rates and strategies that can help support patients and increase adherence to therapy.

Patient Adherence to HIV PrEP

: The goal of patients being on or eligible for PrEP [pre-exposure prophylaxis] is you want to engage them, to get them into care. And in that period, create a level of awareness of their risk behavior, understanding what the risk implication of HIV looks like, what a cure looks like if they do acquire HIV. I think now in the year 2021, when we don’t see the images like we saw 10 or 20 years ago, the impact on the new generation, the younger generation, is that HIV is not even something to think about. I think that’s where we need to be aggressive in engaging that patient.

When a patient comes in, we’ll have that conversation. And then it’s a whole group effort, meaning that I’ll have a pharmacist looking at the medication, insurance charges, look at the mental health of that patient. Because a lot of times, high-risk behavior will go along with substance abuse, use of drugs. And that’s an important component to look at in these patients. The patient-centered care is about understanding that individual and allowing that individual now to have access to clinical care in the sense that here’s a mental health worker, here’s a pharmacist, here’s a social worker. And all of these components need to be there once the patient is engaged to be in care.

What does patient-centered care look like in our practice? For one, I’ve actually hired younger health care providers, my physician assistant, my nurse practitioners. And why did I do that? Because as an older and aging physician, I recognize that my communication skills with the younger generation may be a little different, and I need someone who can have that conversation with someone in their 20s and the teenage years, and a little older, and have that conversation easier than I probably can. I think it’s an important component to recognize that.

It’s also important to recognize that the high-risk individual may be transgender, may be cisgender, may culturally have stigma related to coming into care. These are little pieces that you have to address from very early, have to feel that level of comfort. From the time that person walks into your office, you’ll have a front office person, have communication, and may have a checkout person. So you have to have a clinic that has significant amount of LGBTQ [lesbian, gay, bisexual, transgender, queer] providers involved and personnel involved, to make those patients feel comfortable that the care they’re going to receive is at a cultural level,destigmatized care. Because you hear patients say they’re taking a pill called Truvada. They may wonder is it for HIV, or is it for hepatitis, or is it for prevention of HIV? When you think of that, patients sometimes need to understand that no, it is for PrEP, and it is also for hepatitis C, or also for HIV. These are pieces that you have to really educate patients about.

Sometimes I will see a patient, for example, presenting with emotional issues at home, challenges at home with their parents accepting their personality, accepting their gender issues. I have someone in the office, maybe a mental health worker, maybe someone who has had similar issues, to sit to that person and address those concerns. And then they need to realize that the risk of transmission of HIV is high, but also there are substance abuse questions, mental health issue questions. We wrap all of this into patient care as a whole formula, rather than separating them individually.

Recommendations when talking with patients about goals of HIV PrEP and ensuring a patient-centered approach to care.