While the field of public health has been doing more work to expand knowledge, access, and use of pre-exposure prohpylaxis (PrEP), it has taken a lot more time to fully scale up our first biomedical prevention tool, post-exposure prophylaxis (PEP). But PrEP has given a boost in attention to its predecessor, PEP. At the International AIDS Society Conference on HIV Science in Mexico City in late July, providers presented a poster on New York City's strategy to implement and scale up a hotline for people who think they've had a recent HIV exposure to get quickly linked to medication and care. The poster, "Variability in Comprehensiveness of Sexual Health Care and HIV Prevention", was presented by Emma Kaplan-Lewis, M.D., assistant professor of infectious disease at the Icahn School of Medicine at Mount Sinai in New York City, and Michael Cruz, M.S., program manager with the Mount Sinai Institute for Advanced Medicine.
Terri Wilder: I was really drawn to your poster, because PEP is the older sister of PrEP, and I feel like she gets ignored a lot. So I always love it when I see people doing work around PEP. And this is so interesting to me; your program runs a 24-hour, seven-day-a-week PEP line, which is a hotline for people who are looking for access to that prevention/intervention tool.
If I'm correct, I think that this may be the only line that's available for the community to try to get PEP 24 hours a day, seven days a week.
Michael Cruz: That is also my impression. I haven't seen any other city, municipality, or state do anything similar, where they provide access to post-exposure prophylaxis to patients 24 hours, without having to go into an emergency room.
TW: Can you tell me a little bit about the history of your line? Who funds it? Why was it started? How is Mount Sinai in charge of it?
MC: You know, that's so complicated. So, the line is currently at Mount Sinai. Funding is being provided by New York City Department of Health and Mental Hygiene. The line was previously started and funded through the Elton John [AIDS Foundation] grant, and Dr. Demetre Daskalakis, when he was at NYU Langone Medical Center. Since then it's moved over to Mount Sinai Hospital where it got better funding and it was scaled up. And now I manage the program itself, linking people to the clinics so that they can get the full access for the medications. Because we only provide a starter pack.
TW: Tell me how this works. Let's say that I, on a Friday night, met someone. We had unprotected sex. And I thought, "Oh, my gosh. I may be someone who needs to think about getting on PEP. I don't know the status of my partner." How would I get to the line? What would I expect when I would call the line?
MC: When you called the line, you would be greeted by a provider who is an expert in post-exposure prophylaxis. They would assess your risk, get your contact information and your name and your basic demographic so that they can prescribe the medication. Everything is confidential. Not anonymous. We have had a few of those calls, where people think they can just pick up meds like it's Pez.
And so then the provider assesses, determines whether the risk was high enough to merit PEP. If they see that PEP is needed, they'll prescribe medications to one of our partner pharmacies, enough to get him to the next business day.
So, you said Friday night. We would do three days -- that would be Friday night, Saturday, and Sunday. And then on Monday, they get a call from a patient navigator, getting further information, doing a better assessment, determining where the patient should go. And we try to get them into the Mount Sinai Health System, at one of our five Institute for Advanced Medicine clinics, because they all provide comprehensive sexual health services to our patients.
The medication is provided to the patient free of charge, so they don't have to worry about that. It eliminates the barriers of, "Oh, I don't have insurance," or "I don't want to pay a copay," or "I don't want to go to the ER and wait." We have a pharmacy in all five boroughs. And then we have a handful of 24-hour pharmacies. If they call at 2 or 3 a.m., they're able to go to the pharmacy, one of the 24-hour pharmacies, to pick it up.
And then we also provide birth control for women so that we have a full -- Plan B.
TW: If a person calls, is the medical provider on the phone -- do they ask, like, "Where do you live?" Because I would assume they would want to try to make sure that the pharmacy is close to them, so that that's not another barrier.
MC: Yes. They assess over the phone where they live, or ask them what borough they're in, and offer them the pharmacies we have in that borough, and which one is closest to them.
TW: So, the data from your poster says that you had about 1,231 individual callers to the hotline in 2017, and about 37% received follow-up care at a Mount Sinai Health System clinic. In terms of that drop off, does that mean that the people just picked up their starter pack and never came for the rest of it?
MC: Because of the scale of the call volume, we have to partner with other clinics throughout the five boroughs. And Mount Sinai's health care system is only focused in Manhattan. So we have partnerships with others -- the PlaySure Network -- which is the Department of Health's network of providers that provide comprehensive sexual health services, as well. And so we navigate them.
TW: OK, you just looked at data from what went to Mount Sinai. So, it's completely possible they get linked with a partnering provider.
Emma Kaplan-Lewis: Yes. Absolutely. So, while we don't have additional follow-up data on the remaining two-thirds who did not follow within our system, we did have some basic demographic data. And the populations look similar. So we don't anticipate that they're particularly different, but that is obviously a limitation of this study, that we looked at people who followed up with us.
TW: So, I wanted to talk about your evaluation of some of the data points that you were looking at.
EKL: Sure. Absolutely. We wanted to look at the basic demographics of our overall sample that followed up within Mount Sinai. And then, within our sites, we have both Institutes of Advanced Medicine, clinic sites that have the ancillary support services, often grant funding, to provide comprehensive sexual health care. [And we have] non-IAM sites, also within our system, who don't necessarily have all of those additional ancillary services to provide as comprehensive sexual health care, to see if there are population [differences] as a whole of who followed with us, but also, look at those different sites of follow-up to see if there are differences in STD testing and positivity rates, and all of that.
If you look at Table 1, it's just looking at the basic demographics, and essentially looking at Institute of Advanced Medicine, compared to non-IAM sites, within Mount Sinai. There's really no statistically significant differences by any of the demographic factors, except for insurance status. A higher proportion of uninsured patients went to IAM sites, compared to the demographic of non-IAM sites, as well as Medicaid-insured patients. And there's a higher proportion of privately insured at non-IAM Mount Sinai sites.
So that's just looking at those demographics. But otherwise -- race, ethnicity, age, sexual identity, gender, all were more or less the same between IAM and non-IAM sites.
When you look at Table 2, we wanted to look at various points of access to care. And this is the entire population; not split up by different sites. So, the majority of people who saw midlevel providers -- so, physician's assistant or nurse practitioner -- was 56% -- compared to an M.D. Any follow-up at Mount Sinai Health System was about 37%; so, just over a third.
Three hundred and forty of those people sought care at an IAM site first. In terms of time of call, overnight was about 47% -- those were the after-hours calls or weekend calls -- versus daytime, was 53%. Seventy-one percent of people ended up getting a prescription for a starter pack over the phone. The additional just under 29% of people would have been able to be seen same day to get a prescription. So it's not that they didn't get a scrip, but you only do the phone one if they can't come in because it's a weekend or evening.
In terms of access, and timely access to PEP -- that's a major goal of this program, in terms of shortening access to post-exposure prophylaxis for people who need it -- 96% of people who qualified for PEP were able to get PEP in less than 72 hours. So, we're doing a pretty good job of speedy delivery of PEP to people who need it.
Looking at current or prior PrEP use, there's about 9% of our population who followed at Mount Sinai, who had had current or prior PrEP use. What we do -- because I also do the phone line as a provider every couple months -- so if somebody's on PrEP, you really have to assess their adherence. Based on the PrEP trials, if it's a woman, if they've missed really any more than one pill in the past week, or been on it less than three weeks, you really don't have the mucosal protection. And so you have to do PEP.
For a man, then, the rectal mucosa is a little more forgiving. So if they've had at least four pills in the past week, you don't need to do PEP. But if somebody reports less than that level of adherence, you would do PEP in that setting.
In terms of taking PEP before, about 27% of our population had been on PEP before. So, again, this is a relatively high-risk population. The people we're trying to reach are being reached, in terms of preventative measures.
TW: Can I ask a question about folks who have been on PEP before? Are folks saying, "This is maybe the second we've provided PEP. Do you want to have a conversation about PrEP?"
EKL: That's a great question. So that is one major goal -- not particularly the objective of this poster -- but one major goal of the program is to utilize PEP and need for PEP as entry into care for comprehensive sexual health care, diagnosing, treating STDs; and really having, right away, at that initial provider visit, the PEP to PrEP conversation. Because this is a relatively high-risk group.
Whether the provider will have that information? They have to do the assessment, and have to ask the question. They won't, necessarily. If it was in our system, sure. But if the person had been on PEP from an STD clinic or from somebody else, then not necessarily. And we are working on standardizing our provider template so that all this information, one, can be captured; but also, the way in which we're delivering the post-PEP linkage to care is somewhat standardized across our system, so that we're not missing people who really should be transitioning to PrEP.
And so, just the last line of that -- so the PEP to PrEP -- at least from this baseline here of 2017, was 18.4% were able to be transitioned to PrEP. So, lots of room for improvement; but definitely capturing a decent amount of people.
We had two HIV seroconversions, which were in the setting of really poor adherence.
TW: You also looked at sexually transmitted infection (STI) rates. Can you talk a little bit more about that piece of the poster?
EKL: Yes, absolutely. So, wanting to look at STD testing and then positivity rates, we looked at any sort of gonorrhea/chlamydia testing, whether that testing was positive; any syphilis testing, just based on serology.
When we looked at the various demographics, the only one that was significant age-wise was any syphilis testing; younger people were more likely to be tested for syphilis, had any form of syphilis testing, than older people.
If you look at gender, across the board there were significant differences. Women were less likely to have gonorrhea/chlamydia testing; also less likely to test positive, compared to men -- but fairly high in both groups.
In terms of sexual identity, people who identified as LGBTQ had higher rates of any gonorrhea/chlamydia testing, as well as positivity. No significant difference by gender identity for syphilis testing. But there were higher rates of syphilis positivity in people who identified as LGBTQ. And pretty significantly higher rates of three-site testing for people who identified as LGBTQ.
There's no difference by ethnicity. And, in terms of insurance status, people who were uninsured or had unknown insurance status -- [which] often means they're either undocumented or uninsured -- had higher rates of chlamydia or gonorrhea positivity, as well as syphilis positivity and three-site testing.
When we looked at follow-up, whether people were seen at our comprehensive sexual health clinics, IAM, versus non-IAM, there were higher rates of all forms of STD testing -- gonorrhea, chlamydia, and syphilis, as well as three-site testing -- in people who had follow-up at one of these comprehensive sexual health centers, compared to another, just general medicine, practice.
When we looked at the multivariable logistic regression, controlling for gender, and gender identity, and provider type, and insurance, we did see higher odds of chlamydia and gonorrhea, syphilis testing and three-site gonorrhea/chlamydia testing in people who followed up at one of the comprehensive sexual health clinics, compared to just the general medicine clinic. What's interesting about this is, I think the major finding is that these patients kind of self-select to go to one of these comprehensive sexual health centers. Because it's a conversation, as Michael was saying, about where they're going to follow up. There's something there about whether people are sort of self-identifying as being at high risk, or whether they're more comfortable going to these clinics -- or who knows why? But they're self-selecting to go to clinics and potentially self-identifying as being at higher risk, and, in fact, are -- when you look at the higher STI positivity rates.
What is it about a comprehensive sexual health clinic that is more comfortable, or more appealing, or whatever those reasons are for individuals? And how can we really hone in on that and then target those things and generalize that to the primary care setting? Because not all sexual health can be done in comprehensive centers.
So I think that's really kind of the interesting finding. And also, is it the ancillary services? Is it the culture of the place? Who knows? We don't know. I think we need more qualitative data to get at that. But I think that's the major interesting finding.
TW: And I would think even self-selecting even prior to that is, they were motivated to pick up the phone. Or they happened to see your marketing. So then, they're people who were kind of motivated to take care of their health. So they're self-selecting to begin with.
EKL: Absolutely. Exactly.
TW: I'm curious: How do you find out about this line if you live in New York City?
MC: People generally self-select. So they'll have an exposure and then Google what happened. And then they'll see the number on the New York City website. And then they'll call us.
We've seen it increase. There's no data on this yet. But we've seen it increase in people, like, knowing from word of mouth; they've been talking to someone about it: "I had an exposure."
TW: Are there bus ads, posters, postcards?
EKL: There are media campaigns from the New York City Department of Health regarding PlaySure and Know Your Status, but that aren't specific to this line. But on their website, it is very clearly demarcated in terms of prevention services that you can call this line. When you Google "STD prevention" -- I've sample-Googled it myself -- it's one of the first things that comes up. The sexual health clinics around the city have the number.
And so if somebody comes in after-hours, or if they're coming to one of the off-site clinics that can do PEP but, whatever the time that the person's coming in, they don't have the resources available to do it; we'll get calls sometimes from those centers with the client, because it's like a Friday evening or something like that.
MC: We did a brief Grindr, social media stint for a bit. But the numbers weren't -- they didn't increase too much after that. And we're kind of at capacity, as it stands right now. So we don't want more worried well calling unless they've had a true exposure.
EKL: Yeah. It's sort of like that weird juxtaposition of, you have a program that works. A good amount of people are calling. But if it were to expand much more, we need more resources to support it. But at the same time, we are getting large enough numbers, and doing a decent amount of prevention.
TW: I'm just wondering about folks who maybe don't have access to [the internet].
EKL: I think most of the information would be through looking online. That being said, if you are going to walk into a sexual health clinic -- even just for regular STI testing or anything like that -- you can access the number by going there. If you are totally siloed from the internet.
Also, I don't know the data off the top of my head; but it's surprising how many people, even if there are a lot of competing priorities, or they're very poor, don't have a home computer, or even have transient housing, will have at least temporary access at various points through cell phone service to online, or through a friend or something like that.
We'll get people calling who say, "Oh, my friend, blah, blah, blah, blah, blah." And we won't always know what that friend's situation is. You can't sort of prescribe through that person. But we'll say, "Have your friend call," and they give them the phone and they do it.
TW: Rumor is that you guys are expanding geographically. Is that true?
MC: Yes, this is true. The state is currently working on a work plan. We are expanding to cover the whole New York State area. But because of logistics, because we're New York City–based, we don't know anything about the state. So the AIDS Institute for New York State is doing all the legwork, currently, to find pharmacies and providers to send people to. We have to work with the capacities of a rural area, where the nearest health center might be an hour or two drive. And so they have to work with the logistics of that and provide us the structure of what they want us to do and how to roll it out.
But we have a few more months before that's implemented.
TW: Do you have an anticipated launch date?
MC: It's supposed to be September.
TW: Of this year?
MC: Of this year.
TW: Going from five boroughs to every county in the New York State area is a lot.
EKL: At some point, though, if you've looked at some of the more recent -- even syphilis, they are sort of harbingers of HIV risk, syphilis outbreaks; and even HIV outbreaks, especially in the setting of the opioid epidemic, rural areas in upstate absolutely need prevention.
TW: And New York State, of course, its governor came out with a plan to end the AIDS epidemic several years ago. And there was a blueprint. So, of course, this is very much a part of those goals in ending the epidemic.
This is really exciting. Congratulations on getting to expand it to the rest of the state. We'll look forward to hearing more about that.