[00:05:25]

Pre‑Exposure Prophylaxis Works!

So, why are we talking about these issues? Well, PrEP works. That's the most [00:05:30] important thing to keep in mind. So, whether it's same‑day or whether it's not same‑day, the important thing is we really want to ensure that all individuals who might benefit from PrEP get access to it because, you know, PrEP, which is the use of antiretroviral medication by people without HIV to protect themselves, there's strong evidence that this is beneficial. When taken consistently, it can decrease HIV risk substantially, almost 100% for people who are acquiring HIV by sex. [00:06:00]

We have more limited data for people who inject drugs, so that's why the figure may be a little lower, but ‑ so there are not as many trials in that population. And the important thing is that certainly individuals who are over 35 kilograms who are at risk for HIV, irrespective of age, will benefit from the medication.

[00:06:23]

PrEP Discussions Should Be Part of Routine Medical Care

And, you know, PrEP discussions are recommended to be part of routine clinical care now. The U.S. Preventive Services Task Force [00:06:30] says this. So, it's not that everybody who's sexually active should be on PrEP, it's that we as providers should be talking to our patients about ‑ about PrEP as an option. Some individuals may be sexually active, but they're in stable, mutually monogamous relationships. Other individuals are comfortable using condoms. So, it's not that PrEP is for everybody, but it's a tragedy that there's a large number of people who would benefit from PrEP who are not receiving it. And certainly, this also includes people who [00:07:00] inject drugs, as well as people who are sexually active.

[00:07:03]

PrEP‑to‑Need Ratio in US as of 2023

But in terms of our meeting the metrics, well, there's a construct called the PrEP‑to‑need ratio, just determining how many people could potentially benefit from PrEP who are getting it. And if we just look at different populations in the United States, particularly for people of color, the rate of new HIV infection is ‑ is quite high, disproportionately high among black Americans and Latino Americans, and [00:07:30] yet the PrEP uptake is proportionately lower than compared to white Americans. So, you can see on the graph in terms of the PrEP‑to‑need ratio. There's extreme disparities, the racial disparities. There's less PrEP use in the south in proportion to the relative need in the community.

[00:07:49]

Standard and Same‑Day PrEP Defined

And then, when we think about PrEP, how do we deliver PrEP, there's what we would call standard PrEP, which is how we were doing it several years ago, which is that the person gets evaluated, a [00:08:00] bunch of laboratory tests get sent off. Usually, they take several days. So, the PrEP is prescribed when all the tests come back after seven days.

The same‑day PrEP, though, can be same‑day in different senses as well. There's same‑day PrEP prescription, which means that the clinician takes a medical history. The person doesn't appear to be having acute HIV symptoms. They're given a script, but they're told not to start until they get all the test results.

That's [00:08:30] really not what we're talking about today. Ultimately, what we really are emphasizing with same‑day PrEP start is when PrEP is prescribed and started the same day, the person leaves the clinic with the medication or with a prescription. And this begins after a person gets a rapid point‑of‑care HIV test. And part of what we'll talk about in the first part of this webinar is, what is the data that says that this is a safe thing to do to send off the labs and then get the results a little bit later.

[00:08:58]

IAS‑USA Guidelines: Don’t Delay PrEP!

And basically, one of the [00:09:00] normative bodies, the International AIDS Society‑USA, their guidelines say, just don't delay PrEP because it's ‑ certainly the risk of having a problem, for example, nephrotoxicity from tenofovir with a couple day exposure is a lot less in terms of long‑term health consequences than somebody leaving the clinic without a script and becoming infected with HIV. But the important thing, we certainly want to know that the person is not living with HIV [00:09:30] because then they'd benefit from more complex medical regimen. So, we want to make sure that they are HIV uninfected with at least the best rapid evidence we have. So, we definitely want to have a rapid point‑of‑care test, test for antibody and antigen that will allow us to determine whether the person was recently infected. And the PrEP can then be started. The individual can [00:10:00] begin the medication while waiting for the test results.

[00:10:05]

Rationale for Same‑Day PrEP

You know, and the rationale is this. That somebody who leaves a clinic and is told, "Well, you'll have to come back another ‑ another clinic," take time off from work, have to find parking. At my clinic in urban downtown Boston, parking is not a small matter. So, if you can do things in one visit versus two visits, that's a big deal. People are ready if they're mentally ready to get the script. Best [00:10:30] to reinforce that people are protected sooner, and it's a better overall patient experience.

[00:10:39]

Same‑Day PrEP Initiation: A Strategy to Improve Access

It's really important to think about it's not one‑size‑fits‑all. It may not be perfect for everyone. So, there are a number of things that we have to consider. Certainly, we have to think about the barriers for PrEP that people have. And certainly, we think that it's decreasing barriers by reducing office visits and travel time. [00:11:00] It may increase engagement in care, and it may be similar to what people have for other medications. Like, why are you taking so long to give me this medication when I got my initial script for my statin so quickly, for example. But there certainly are reasons that same‑day PrEP may not be the right thing either.

They're cost issues. Some of the PEP medications or PrEP medications require prior authorizations, and that can be problematic and ‑ and take [00:11:30] time. So, it may not be feasible to get the same day if the person thinks they may have a huge out‑of‑pocket expense. So, there are cost issues. And certainly, some people's insurance will require different kinds of documentation that a clinic may not be able to provide very quickly.

It may be more complicated getting the labs turned around quickly as well, or getting contact with a pharmacy to get the medication same‑day.

There may be other individuals who [00:12:00] may have clinical reasons why you may not want to consider same‑day PrEP. If somebody has known renal disease, you may obviously want to know the creatinine before starting a tenofovir regimen. Certainly, if somebody has symptoms of acute HIV infection, that's not a candidate for PrEP. So, certainly if there's any suspicion of that, one would wait about same‑day PrEP.

And certainly, if somebody is in the middle of travelling or has an unstable housing situation, certainly you would prefer to have [00:12:30] all the information because you wouldn't want to start the medication and then find that there's a lab that needs to be acted on and you're not able to reach the patient.

[00:12:39]

Same‑Day PrEP: Supporting Evidence

So, here are some of the supporting evidence that says that same‑day PrEP is quite feasible.

[00:12:45]

Immediate PrEP Initiation at New York City Sexual Health Clinics

One of the largest studies was from the New York City Health Department from their sexual health clinics. They offered PrEP to 1,437 individuals who had ‑ had indications [00:13:00] initially. And they ‑ they screened people, they said, "Does this person have signs of acute HIV?" So, that could be a flu‑like illness, high fevers, lymphadenopathy in the setting of recent exposure to somebody have renal disease the day of a history of prior HIV infection.

So, the vast majority of people said no to all those things. And they had a rapid test done, and then they had HIV NAAT sent off and metabolic panel sent off [00:13:30] as well. And the vast majority of individuals, 1,383 out of 1,437, screened out for all of that and started same‑day PrEP and continued on it.

On the other hand, they did have four individuals who had to stop PrEP because they either had acute HIV or renal disease. There were people who they were concerned about, and so there were 50 individuals where they delayed PrEP. They sent off the NAAT, they did HIV serology, [00:14:00] and the metabolic panel, and they found that there were four individuals, again, that they picked up with either acute HIV or renal disease. So, they did pick up a few people, but again, more than 90% of the people who they delayed were able to continue. And then they were offered PrEP, but only 15 of them started PrEP. So, in other words, there was a bigger fall‑off by delaying rather than starting same‑day PrEP right away.

[00:14:29]

Same‑Day PrEP Initiation at Drop‑in STD Clinic

Another experience [00:14:30] Dr. Rowan and colleagues reported on. I think it's very important one, from Denver, where there's sort of full‑bore system set up. This involved a nurse practitioner or a registered nurse assessing PrEP eligibility with physician oversight. Certainly, wanted to make sure people were willing to start same‑day PrEP. Baseline screening was done with all the appropriate tests and people were given a 30‑day PrEP starter pack. Discontinuations [00:15:00] didn't happen. So, there weren't any abnormal labs that they found. The majority of individuals completed one follow‑up visit, and over half completed a second visit.

So, this is a problem we have with PrEP in general. So, same‑day PrEP is not a panacea in terms of PrEP persistence. But what they found was that you could not predict who was not going to be able to continue [00:15:30] on the appointments other than income. So, certainly that is a challenge for people. So, people who have more economic challenges, staying on same‑day PrEP may ‑ may be a challenge. But overall, they had a bunch of people, majority of people completing a survey, and everybody likes same‑day PrEP. So, it certainly showed high feasibility, high acceptability.

[00:15:54]

Same‑Day PrEP: Real‑world Models

There are several other real‑world models that we can look at. At [00:16:00] Washington University in Saint Louis, they set up a clinic program, and they gave people the option of same‑day or waiting. 97% of people want to start same‑day PrEP, and more than three‑quarters continued for more than three months. And again, no discontinuations because of baseline laboratory abnormalities.

Howard Brown Clinic in Chicago has partnered with local pharmacies, so they have a bottle‑in‑hand system where they can give people the first dose with clinic staff. They have [00:16:30] an arrangement with the pharmacy. And at the end of their experience over several years, they found that almost three‑quarters of their PrEP prescriptions were same‑day.

In Seattle, King County they've done very nice work working with the local pharmacy and with the PrEP navigator. More than 1,000 patients who've received 30‑day oral PrEP prescriptions, and the vast majority, 86% deciding to do same‑day PrEP.

[00:17:00] [00:17:00]

Same‑Day PrEP: Pharmacist‑Led at Mississippi Nonclinical Testing Center

In Mississippi, they had a pharmacy‑based PrEP service, and they looked at their cascade. And the good news was that the majority of people, almost all, agreed to receive PrEP and the majority filled their PrEP prescription, but there was drop‑off. So, again at the further side of the cascade, we have to think about what can motivate people to stay on PrEP once, you know, once [00:17:30] they initiate it. But certainly, the initiation part of the same‑day PrEP seems very solid.

[00:17:35]

Same‑Day or Next‑Day Long‑Acting PrEP in Safety Net Setting

And then lastly in terms of injectable PrEP, there's less information because it's more recent, but some really excellent work has been going on in San Francisco, at Ward 86 at San Francisco General Hospital. They've followed a population of individuals, many of whom are unstably housed, have multiple comorbidities, including substance [00:18:00] use. And they ‑ they found that starting long‑acting cabotegravir, the 63 individuals that they followed, about a third received long‑acting PrEP within 24 hours. And once they did it, their follow up was ‑ was excellent with over 80% retention at six months. So, again, long‑acting PrEP is quite feasible in multiple different populations.

So, [00:18:30] I'll turn the podium over to Dr. Rowan now to talk some more about monitoring and other related issues.

[00:18:35]

Same‑Day PrEP: Testing and Monitoring

Dr. Sarah Rowan (University of Colorado School of Medicine): Thank you. Hi everyone. I'm going to talk about some of the logistical issues around same‑day PrEP.

[00:18:45]

Same‑Day PrEP Requirements

So, first off, same‑day PrEP requirements. PrEP is prescribed and started the same day as the initial visit. This is what we're talking about. So, prescribed and started same day. And PrEP starts after [00:19:00] negative rapid point‑of‑care HIV test while awaiting complete lab‑based blood test results. So, these are sort of the two kind of distinguishing features of same‑day PrEP, that it's prescribed and started the same day as the visit, the same day the person comes in and says, "Hey, I think I want to take PrEP," or I'm here for something else and you brought up PrEP, and that sounds like a good idea. So, same day as that. And then it starts after a negative rapid test but while awaiting full lab results, all the rest of the labs [00:19:30] besides the rapid test.

So, clinicians should conduct a point‑of‑care HIV test and a pregnancy test if relevant. And ideally, the pregnancy test will come back with the same‑day result. And then we'll be sending a lab‑based fourth‑generation HIV antigen/antibody test and/or an HIV RNA test, depending on your protocols. But essentially, we'll be getting a point‑of‑care HIV, [00:20:00] getting real‑time pregnancy tests, and then sending lab‑based HIV tests as well, which we won't have the results for right away.

And another point to make here is that the point‑of‑care HIV test, it should be a fourth‑generation HIV point‑of‑care test if possible. And we know that with point‑of‑care, the fourth‑generation antigen component may be less sensitive, but that is what's recommended. The oral rapid test is not recommended. [00:20:30] So that is less sensitive, and so we recommend a point‑of‑care HIV test prior to starting PrEP if possible. And we have some caveats toward the end when that's not possible. But ideally, you have a rapid fourth‑generation HIV test, not an oral rapid test.

And then we'll be drawing blood for laboratory‑based creatinine if you're starting oral PrEP and HIV testing, and particularly if same‑day results are not available. But even if they are, [00:21:00] we're still sending lab‑based HIV tests. We'll review lab results in ‑ within, you know, 72 hours or less and then rapidly follow up about any reactive HIV tests, obviously, if renal dysfunction is identified, if someone is surface antigen positive for hepatitis B, indicating that they have hepatitis B infection. And then if they are negative for surface antigen and surface antibody, then we'll be following [00:21:30] up to advise vaccination for hepatitis B.

Dispense, prescribe oral PrEP, or administer the PrEP injections. Collect specimens for other STI testing. Schedule follow‑up tests and appointments, and then assist with enrolment in cost assistance programs or health insurance as relevant. So, these are kind of the main ‑ tenets of starting same‑day PrEP.

So, point‑of‑care HIV, point‑of‑care pregnancy labs, a plan to [00:22:00] review labs with the patient within 72 hours, dispense, prescribe, and fill, collect specimens for other STI testing, schedule follow‑up appointments, and then assist with enrolment as needed.

So, that's kind of a busy slide, but that is the main kind of overview of what we'll be doing on a same‑day PrEP visit.

[00:22:20]

Monitoring: At PrEP Initiation

So, in terms of monitoring for PrEP, the monitoring isn't any different than it is with standard non‑same‑day PrEP. But essentially, [00:22:30] we'll be getting an HIV test with an antigen/antibody assay plus/minus an HIV RNA, and the ‑ and that's going to be during PrEP initiation. And then I have some slides about what to do during follow‑up.

But at initiation, the current guidelines are to get both of these tests, the standard and the RNA, when starting oral and injectable PrEP, STI testing, hepatitis B serology. If you'll be starting F/TAF [00:23:00] formulation of oral PrEP, it's recommended to get a cholesterol and triglycerides to get a lipid panel because of the possible effect on lipids of F/TAF. And then to check kidney function if you'll be starting oral PrEP.

Injectable PrEP lipids and kidney function are not affected, so you don't need to start that prior to ‑ to order those prior to starting injectable PrEP.

Similarly, injectable PrEP doesn't affect hepatitis B, so [00:23:30] understanding the person's Hep B status is less critical. It's still reasonable to get it, but it's not required prior to starting injectable PrEP.

Then, PrEP can be prescribed based on that negative HIV antigen/antibody rapid test while awaiting all of the other test results. So, including the Hep B result, including the lipids and the kidney function.

Monitoring: Follow‑up During PrEP

So, then here's the follow‑up. And it's recommended by CDC to get an antigen/antibody and an HIV RNA every three months for both oral PrEP and injectable PrEP, except for the RNA is not required for lenacapavir injection.

Serum creatinine for oral PrEP every six months [00:25:30] if there's risk factors for renal dysfunction, every 12 months if no risk factors.

STI screening every three months for all people with signs or symptoms, and asymptomatic men who have sex with men who are at risk for STIs. Every six months for other populations and every 12 months for the lowest risk populations, really kind of guided by a sexual history.

And then injectable PrEP, creatinine [00:26:00] monitoring is not required, and STI testing is listed there every four months because that's a little bit more practical with the injectable PrEP schedule.

And then lipid panel every 12 months for folks who are on FTC/TAF.

[00:26:19]

HIV Monitoring While on PrEP

So, I wanted to mention a word about the HIV testing. So, at initiation or resumption of [00:26:30] PrEP, both CDC and IAS‑USA recommend the antigen/antibody plus an RNA test. But then for routine maintenance, you'll notice that IAS recommends just an antigen/antibody test, whereas the CDC is still recommending an RNA. There's some data to suggest that the RNA every three months may not be necessary. So, that's something that can be decided clinic to clinic, and you can determine your own protocols for that. But just wanted to make a note that it [00:27:00] is different in these two guideline panels.

And then for CAB, similarly, antigen/antibody plus RNA every two months is recommended by CDC, whereas IAS recommends just the antigen/antibody test.

And then lenacapavir, antigen/antibody every six months. And IAS says antigen/antibody every six months, but more frequently if also testing for STIs. So, if you're testing for STIs every three months, the IAS recommends an HIV test at that time. [00:27:30] So, there's some small changes and differences in the different guidelines.

[00:27:35]

Same‑Day PrEP: Choosing Among PrEP Options

So, choosing among PrEP options. There's a wide array of PrEP options now, and so what is best for a particular scenario is influenced by available data based on exposure type. And we'll get into which populations it would be appropriate to use which PrEP formulation for. But if someone's main risk factor for HIV is injection drug [00:28:00] use, then you'd be doing different options than if their main risk factor is through sex.

Comorbidities, especially renal disease. Folks who have renal disease will probably not be taking TDF/FTC, TAF/FTC, or one of the injectable formulations would be preferred.

Drug‑drug interactions, especially with lenacapavir, you need to review those carefully before starting. And then, most importantly, is patient preference.

[00:28:26]

What Is the Ideal PrEP Regimen?

So, we know that the ideal [00:28:30] regimen is the one that the person decides to take because that's the thing about PrEP is, you know, it works if you take it. So, the ideal can change depending on each person's journey. And here are kind of the main options: FTC/TAF, on‑demand CAB, or LEN or FTC/TDF. So, two oral options. Two approaches to taking oral options CAB and LEN.

[00:28:58]

Current PrEP Options

And so, the current [00:29:00] PrEP options. For the once daily oral pills, we do have FTC/TDF, and we have FTC/TAF. So, I've said that multiple times now, but I just really wanted to put it here clearly that these are the two oral daily options. FTC/TDF can be used as an on‑demand approach instead of daily for cisgender men, and that is supported by international guidelines, not the CDC guidelines. [00:29:30] And PK data may support on‑demand for all populations, but right now it's only been studied for cisgender men who have sex with men to use on‑demand. And I have a slide about on‑demand PrEP, on how that looks in a minute.

And then FTC/TAF is not approved for protection against HIV acquisition through receptive vaginal sex or for people who inject drugs. So, for cis women who have receptive vaginal sex, TDF/FTC is preferred. [00:30:00] Same with people whose HIV risk is shared injection equipment.

And then the long‑acting injections. Cabotegravir, it's an IM injection every two months, and there's a seven‑day window on either side for when that injection is received.

And then lenacapavir, our newest tool in the toolbox, is given subcutaneously every six months, and there's a two‑week window for that one.

[00:30:30]

Why Some Might Need a Long‑Acting HIV Prevention Option

So, why might ‑ why some might need a long‑acting HIV prevention option. Daily oral PrEP is effective, but it's not ideal for everyone. As anyone who is currently offering an injectable PrEP regimen knows, there's a lot of interest in injectable PrEP. So, long‑acting options may be helpful for folks with daily adherence challenges. And it's mentioned for people who have drug or alcohol use, but really a lot of people have daily adherence [00:31:00] challenges. So, I think that's kind of the biggest draw for a lot of people who want to be on PrEP but are afraid that they can't remember a daily pill or even an as‑needed pill.

And then stigma. So, some people feel that they don't want to have a medication in their bathroom or in their ‑ in their ‑ in their medical closet. So, they would prefer an injection because they feel stigmatized.

And then people with travel, [00:31:30] with frequent time zone changes, may have trouble remembering their daily PrEP. And really just offering the choice is so powerful to people as they can have a choice in which PrEP formulation they take, and that really drives adherence.

[00:31:46]

Preference Influences PrEP Choice

So, the PURPOSE 2 trial evaluated twice‑yearly lenacapavir versus daily FTC/TDF as HIV PrEP in cisgender men and trans women and men and gender non‑binary [00:32:00] people aged 16 years and older, and they found that factors influencing preferences for specific PrEP modalities were multifaceted. Those favoring twice‑yearly injections cited perceived efficacy, adherence, feasibility, and convenience, which is probably what we would all have guessed as terms of why these injections are preferred. And those favoring daily pills reported that the pain and discomfort of [00:32:30] an injection was a primary motivator to opt for pills.

So, the investigators concluded that recognizing people's preferences may improve discussions, uptake, and adherence to PrEP among diverse populations. Again, just really underscoring that preference drives adherence. So, it's cool that we have options now, which wasn't the case 10 years ago.

[00:32:51]

Choosing Between PrEP Options

So, choosing between PrEP options. The pros: again, the oral options, widely available. They don't require an injection, [00:33:00] and the visits are quarterly, so every three months.

Cons are the pill burden. Efficacy is affected by nonadherence. And on‑demand dosing for FTC/TDF. Some people may find this complex.

And then the injectable. The pros: it's long‑acting, every two months or every six months, depending which option people take. Does not require daily adherence. May provide more confidentiality.

But the cons is that a healthcare provider [00:33:30] is required to administer the injection, so it can't be done in someone's home on their own time for the most part. And it must ‑ they must present for injection visits and can lead to resistance development before or during treatment or following discontinuation if HIV is acquired. So, just to say, there's this very long tail with the injectables. And if someone doesn't get coverage with an oral medication and then gets HIV, there is a very high risk [00:34:00] for resistance to the components of the injectable prevention medicine.

Long‑acting PrEP can be same‑day. So, as we mentioned, there was one study of long‑acting PrEP same‑day. Consent needs to be obtained to the fixed follow‑up windows. So, we need to make sure that someone can come back in two months if that's the one that we're starting ‑ we're starting CAB, and there are systems in place for managing missed doses. So, if the above are unavailable, then oral bridging can be started. [00:34:30]

So, just a reminder that if someone is not going to be able to come back in two months, something came up, they need to be gone for three months, we need to be able to get them oral PrEP to take until they can come back for their next injectable treatment so that they don't have some time where they're uncovered, and particularly with that tail, as I mentioned, because of the risk for resistance if someone gets HIV.

On‑Demand Oral FTC/TDF PrEP

So, I had mentioned before a little bit about on‑demand PrEP, and it's again only approved with FTC/TDF at this point because that's how it was studied [00:36:30] in the IPERGAY study. It was a double‑blind randomized study of on‑demand FTC/TDF versus placebo as PrEP for men who have sex with men in France and Canada.

And you can see in the placebo‑controlled randomized trial, there were 400 participants. And the risk reduction was 86% with on‑demand PrEP. So, we know that it is highly impactful and effective for people who don't want to take a daily pill [00:37:00] but do want to have the option of on‑demand PrEP for HIV prevention.

And then they did an open‑label extension where people knew which formulation they were taking. They knew that they were getting on‑demand PrEP, and it was 97% effective in the on‑demand open‑label extension.

So, the way it works is people take two pills, 2 to 24 hours before sex. So, it does require some predictability [00:37:30] with someone's sex life. And then one pill 24 hours after the first two pills, and after sex, and another pill 48 hours after those first two pills. So, you wind up taking four pills for each ‑ for each time someone has condomless sex to prevent HIV.

Not recommended for Hep B coinfection. Very important point here that if someone has hepatitis B, they can be on PrEP, they can be on oral [00:38:00] PrEP, but they need to stay on oral PrEP. And then when they decide to go off of oral PrEP, they need to discuss it with their medical provider and be closely monitored to avoid a Hep B flare. But on‑demand, the way someone's taking it and then not taking it, the intermittent ‑ the intermittent medication exposure can be risky for hepatitis B flare. So, if someone has Hep B, on‑demand is not an option for them.

Similarly, those who may just find the [00:38:30] whole thing too confusing, it's better to just do oral or injectable.

And then people at risk of HIV from vaginal exposure, 2‑1‑1 is not recommended at this time, although, you know, that may change in the future.

[00:38:45]

Evidence Supporting PrEP Use

So, I've gone over lots of different caveats, and here's kind of a nice overview of the different ‑ five different PrEP options: daily FTC/TDF, on‑demand FTC/TDF, daily FTC/TAF, every two months IM CAB, [00:39:00] every‑six‑months subcutaneous LEN.

And then different populations and risks. And so, insertive anal or vaginal sex, any option is available. Receptive anal sex, any option is available. Receptive vaginal or neovaginal sex, the on‑demand option isn't available, and FTC/TAF has not been well studied yet, but it may be effective.

Injection drug use, really the only option that has data is daily [00:39:30] FTC/TDF, but for people who want to take injectable, it may be considered.

And then for people who are pregnant or breastfeeding, the injectable options are available, as is FTC/TDF. The recommendation to initiate with a double dose is obviously inherent to the on‑demand approach, but also has been recommended with FTC/TDF. So, when people start PrEP, they can start [00:40:00] with a double dose to decrease time to protection.

And then creatinine clearance less than 60 but more than 30, the TDF options aren't recommended. You really need a creatinine clearance over 60 for FTC/TDF.

And then if people have osteopenia or osteoporosis, we try to avoid FTC/TDF as well.

So, these slides will be available, and I think this one is very useful.

[00:40:30]

Expanding PrEP Uptake

So, expanding PrEP uptake. We'll talk a little bit about how to put some of these ideas into practice.

[00:40:37]

Expanding PrEP Uptake

So, reminder to people: it doesn't require HIV expertise. PrEP is much simpler than HIV treatment, and HIV treatment has gotten very simple recently. So, if you have a patient who's interested in PrEP, don't worry if you don't know that much about HIV treatment.

It's recommended to inform all patients about PrEP regardless of perceived risk. All [00:41:00] patients, per USPSTF, should be informed about PrEP and given the option. And uptake will remain stagnant if few people prescribe. So, it's really important that it's not just infectious disease or just selective primary care, but that prescription is widely available through many different types of medical providers.

And we can learn from contraceptive care in the United States. The expansion of contraceptive care services beyond OB/GYN and midwives, vastly [00:41:30] increased access to and prescription of contraception. So, really encouraging not just primary care, but also OB/GYN to think about PrEP and potentially several other providers.

So, other prescribing healthcare providers, family medicine, internal medicine, pediatricians, NPs, PAs. And this especially can be important in rural areas where specialty and specialized access is limited.

[00:41:56]

Everyone Has a Role

So, any HCP can inform patients about PrEP. [00:42:00] So, if you're a surgeon, you can inform patients about PrEP, if you're a medical assistant, any healthcare provider licensed to prescribe medications can prescribe PrEP. So, you certainly don't ‑ don't need to have specialized expertise to prescribe PrEP.

And primary care providers, family medicine, internal medicine, APPs, and clinical pharmacy practitioners can prescribe PrEP. And that, you know, varies depending on jurisdiction, but in many places, [00:42:30] clinical pharmacists are prescribing through clinical practice agreements and other arrangements.

Healthcare providers who do STI management, substance use disorder treatment. This is a great potential place to talk about PrEP and prescribe it. And then sexual health and reproductive health care as well.

[00:42:50]

When and Where to Consider Same‑Day PrEP

So, when and where to consider it?

Sexual health clinics; that's where I work in a sexual health clinic, and we find that this is an ideal [00:43:00] venue to discuss PrEP because you're talking about someone's sexual health. And primary care clinics.

Emergency departments are an emerging venue for PrEP prescriptions. And we think this is probably very safe and potentially highly effective to reach folks who aren't getting much health care otherwise.

Harm reduction centers can be a place to discuss. And if you have prescribers available, this could also be a really important way to reach people who aren't getting health care at other places, and maybe at risk [00:43:30] for HIV. Similarly, substance use treatment centers.

And the populations: really anyone seeking HIV or STI testing, it's important to discuss PrEP and consider prescribing if indicated. Individuals who inject drugs. Pregnant persons at increased risk for HIV. Individuals whose sexual partners are living with HIV and not on antiretroviral therapy. So, if someone discloses to you that they have a partner who is HIV positive and they're not sure about their medication adherence, [00:44:00] this is a high priority for PrEP.

And then don't forget people completing nPEP. Very high priority to discuss PrEP.

[00:44:09]

nPEP as an Option for Same‑Day PrEP

nPEP is nonoccupational postexposure prophylaxis that is giving a full HIV regimen. So, typically BIC/FTC/TAF or dolutegravir + TAF or TDF + FTC. And that is a recommended 28‑day course of treatment for a potential HIV exposure that occurred within [00:44:30] 72 hours prior to presentation, typically with someone who is HIV positive without sustained viral suppression or viral suppression information is unknown, or someone's HIV status is unknown, and the exposure poses a substantial risk for HIV.

The CDC nPEP guidelines have some algorithms to help you decide what's higher risk and what's lower risk, and when nPEP should be recommended. But nPEP is certainly a great opportunity [00:45:00] to discuss PrEP and to transition directly to PrEP.

[00:45:04]

nPEP Completion Is an Opportunity for Continued Protection With Same‑Day PrEP

So, after 28 days of nPEP, individuals with ongoing risk for HIV can transition directly to PrEP either oral or injectable PrEP. And when transitioning, there's no need to delay PrEP. You can start it right away. And getting ‑ and then you're getting an HIV test result which you'll be following up with the patient for the result.

[00:45:28]

Same‑Day PrEP: Special Situations

So, a few slides [00:45:30] in the last five minutes or so about special situations.

[00:45:34]

Situations for Shared Decision‑making: Rapid HIV Test Result Not Available

Sometimes we don't have all the perfect conditions in place, but a same‑day PrEP is not necessarily off the table. So, what if a rapid HIV test result is not available? So, some primary care clinics don't have rapid HIV testing available? You can review the timing of the last HIV test and the timing of the person's last sexual activity or injection drug use and confirm [00:46:00] contact info for abnormal results. And then, really, it's going to be shared decision‑making.

So, if you don't have a rapid test and you're going to send a lab‑based HIV test and you want to start same‑day PrEP, you really need to have contact information so that if the HIV test is positive, you can convert to HIV treatment immediately. The patients need to know that if they have undiagnosed HIV that there ‑ and they take oral PrEP, [00:46:30] then there is a risk for an M184V mutation. Or if they're starting long‑acting CAB, then there's a risk for developing integrase inhibitor mutations if they have HIV unrecognized. And there's also a possibility for long‑acting early viral inhibition. So, it may delay HIV diagnosis.

So, just really, I think case to case. If you don't have a rapid HIV test available but you have a patient [00:47:00] for whom PrEP could be beneficial, I think starting is not unreasonable as long as they're aware of the risks of starting PrEP with unrecognized HIV. And you can get an HIV test and lab‑based, and you have contact info, so you can confirm that you can reach them.

[00:47:19]

Situations for Shared Decision‑making: Unclear History of Renal Disease or HBV

Another situation for shared decision‑making would be an unclear history of renal disease or Hep B. So, we mentioned that you don't have to have the lab results available before you start PrEP. But [00:47:30] if someone reports a history of renal disease or hepatitis B, typically we wouldn't be starting same‑day oral PrEP. Injectable PrEP is fine. However, you know, if the risk for HIV is high, you could consider it if there's an unclear history while you're waiting for the labs. Fortunately, the short‑term use of oral PrEP, even TDF, is unlikely to worsen renal function in the short term. So, again, you'd want to confirm contact info. And then if they say, "I think I had a kidney problem, I don't know what it was," and [00:48:00] it turns out their creatinine clearance is low, you could reach them and switch their PrEP, you know, in short order.

Similarly, if they say, "I don't know if I had Hep B. I'm not ‑ I'm not real clear about that." If you wouldn't be wanting to ‑ you wouldn't start 2‑1‑1, but you could start oral PrEP and if it turns out that they are surface antigen‑positive, you just reach the person and tell them "Hey, you do have hepatitis B, so you need to stay on treatment because it's also treating your Hep B, and [00:48:30] when you stop, your Hep B could flare, so we need to be closely monitoring you."

Counsel on the recommendation for adherence to oral daily PrEP for individuals living with Hep B ‑ what I just said.

And then individuals living with Hep B should consult an ID specialist and hepatologist prior to stopping daily oral PrEP.

So, those are the caveats for people with kind of an unclear history while you're waiting for lab results.

[00:48:52]

Framing PrEP as a Positive Health Choice

And then we think that framing PrEP as a positive health choice is incredibly powerful. So, [00:49:00] emphasize that taking PrEP is about empowerment and self‑care. It's not about risk behaviors, or it's really about taking control of your health so that you can live the life that you want to live.

Acknowledge there is some stigma and reinforce the benefits of PrEP. And hopefully this person is not experiencing any stigma. But if they do feel like they could be, then that is a very real experience for that person that should be honored and discussed.

You can present PrEP as a routine prevention [00:49:30] option for all sexually active persons, similar to contraceptive ‑contraception and HPV vaccines. This doesn't need to be just for specific groups or folks who are considered high risk. This is really routine HIV prevention.

And share real‑world data showing PrEP users do not necessarily increase their overall risk behaviors. So, there's no reason to think that because someone starts PrEP, they're automatically going to stop using condoms or make other choices that increase their risks. [00:50:00] And PrEP improves safety when engaging in risk behaviors. So, it's really win‑win.

[00:50:09]

Establish Relationships With Community Centers to Increase PrEP Awareness and Referral

Establish relationships with community centers to increase PrEP awareness and referral. So, we're not suggesting that food pantries prescribe PrEP, but one thing if you do community engagement work, it's really important to discuss PrEP with folks because these places that people go—support groups, harm reduction [00:50:30] services, mobile care units, food pantries, pharmacies, libraries—can all recommend PrEP to people. So, they can increase awareness and they can drive folks to your practice to discuss PrEP. So, kind of great partners to have.

[00:50:46]

Considerations for Paying for PrEP

Considerations for paying for PrEP. It's covered by most insurance programs and Medicaid. It's required by the ACA. So, if someone has coverage, PrEP should be covered. Sometimes prior authorizations are required.

Low‑cost options [00:51:00] are available through GoodRx, mostly for FTC/TDF.

340b pricing may be available for patients without insurance in some clinics, so check with your local 340b providers to see if they have low‑cost FTC/TDF.

And then there are manufacturer assistance programs for all of the different options. You can check with your state health department as well. I know in Colorado, our state health department has a robust PrEP assistance program. And then [00:51:30] some states have assistance programs.

So, with that, I think we're kind of winding up ‑ winding down with the key points.

[00:51:38]

Prescribing PrEP: Key Points for Implementation

So, prescribing PrEP implementation. We talked a little bit about the need for more PrEP. We talked about the data behind the safety and efficacy of same‑day PrEP.

And then the key points for implementation is that same‑day PrEP decreases barriers to PrEP uptake. It minimizes the number of people lost at the early points in the PrEP care continuum, and it increases [00:52:00] timely uptake and accelerates the onset of protection against HIV.

PrEP should be started as soon as possible following a negative rapid HIV antigen/antibody test.

The choice of PrEP regimen should be based on the needs and preferences of each patient. So, modality frequency, adherence, and comorbidities. So, really tailor the PrEP options to the patient.

And settings with access to point‑of‑care testing, the ability to provide prescriptions, [00:52:30] and provide appropriate follow‑up can implement same‑day PrEP.

So, with that, I will turn it over to our team for the posttest. And actually, yeah. Okay. So, I think ‑ is this the one? I'll go ahead and say this one.

[00:52:49]

Posttest 3

I recognize which patient groups represent the best opportunities where same‑day PrEP initiation can have the biggest impact.

Okay. And [00:53:00] hopefully that is something you're answering now.

[00:53:07]

Posttest 4

And then the final posttest. I know what steps I need to take to successfully implement same‑day PrEP in my practice. Can answer that one.

[00:53:18]

Audience Q&A

Cool. And now we are at the audience Q&A, so I'll turn it over to Dr. Mayer.

Dr. Mayer: Thank you. Thank you, Dr. Rowan. So, hopefully we've covered [00:53:30] this topic fairly thoroughly, but there are a few questions that I think always come up that are very relevant.

One is: What happens if the point‑of‑care test is ambiguous? How would you handle that, Sarah? That's my own ‑ own thoughts.

Dr. Rowan: Yeah. So, you know, we ‑ we will repeat it. We don't get too many ambiguous point‑of‑care tests. You can definitely get false positive point‑of‑care test. That is something that we see regularly. And [00:54:00] so, if you had a positive point‑of‑care test, I would defer until I had a confirmatory test result, and then I would start HIV treatment. If it's ambiguous, I think I would be repeating the test. And if it's ‑ the point‑of‑care is again ambiguous, I would hold off and do a lab‑based test to get a more definitive answer.

Dr. Mayer: Yeah, I agree with you. I mean, the other thing, which I don't think is ‑ is common is that you could use a different point‑of‑care test, you know, but [00:54:30] a lot of clinics don't have that ‑ that availability. But there are ‑ there are more than one, you know, fourth‑gen point‑of‑care tests available.

And yeah ‑ and for everybody in the audience, please feel free to share any questions that you have for us in the Q&A. But ‑ but we'll keep going because one of the questions that I have is just, where in your practice right now in ‑ in Denver, what would you say the distribution is overall of what percent [00:55:00] of people are same‑day PrEP, and of the people who are same‑day PrEP, what percentage are getting ‑ initiating with rapid medication ‑ excuse me ‑ with long‑acting medication versus oral medication?

Dr. Rowan: For us, our standard of care is same‑day PrEP. So, unless someone has a contraindication to starting same‑day, that's what we'll do. So, the majority of folks that are seen in person in our clinic are starting same‑day. We [00:55:30] also will do telehealth visits for PrEP. So, in that case, if someone has a recent HIV test, we'll prescribe it same day as a telehealth visit.

Otherwise, we have folks come by the lab and do blood work. And then as soon as we have the negative HIV test, we start PrEP. But if they're in person, because we have rapid HIV testing in our sexual health clinic, if the rapid HIV test is negative, then we start same‑day PrEP. And the majority of the same‑day starts are oral because we have [00:56:00] to get approval for cabotegravir. And we're hoping to implement lenacapavir in the next month. But it's just a little bit of paperwork. So, we have ‑ in our practice, we're not starting same‑day injectable. We're getting the labs and having folks come back within a week to start injectable.

Dr. Mayer: Yeah, I think we're very similar. I wouldn't ‑ I don't think we're at the point yet where I would say that same‑day is the default mode, but I'd say definitely the majority of people who are starting [00:56:30] PrEP these days are same‑day. So, the clinical practice at Fenway Health is, you know, people are ‑ are comfortable prescribing same‑day PrEP pretty routinely. But in terms of the injectable, I think the biggest issue is, as you say, the insurance that, you know, we have, you know, we have a lot of access to the medications, but there's still some prior approvals and some paperwork. We actually have legislation going [00:57:00] through our state ‑ state government to try to sort of simplify the process, make it more accessible, but it's still a work in progress.

Have you encountered any other ‑ anything that we've covered today, any ‑ any of the things that you think are the biggest sticking points for people to think about as they migrate their practice towards doing more same‑day PrEP? I mean, any growing pains that you felt that you encountered [00:57:30] in Denver?

Dr. Rowan: Yeah. We really ‑ I think the biggest sticking point is just coverage. I think medically, we're not seeing ‑ we're not running into problems. You know, you could have someone who had a negative rapid, and their lab‑based test was positive, in which case we would be calling and converting to HIV treatment. So, if the rapid is not as sensitive for the antigen, and so you don't catch HIV as early, [00:58:00] an acute HIV, that's a possibility.

We've seen when people do same‑day starts, they have pretty much the same kind of long‑term PrEP retention as people who do, you know, not same‑day starts. So, that hasn't really been a problem. So, I think the main thing is ‑ is just getting folks enrolled in the Advancing Access Program if that's the path that we're going through. We also have a program called the Public Health Assistance [00:58:30] Program, and we get people enrolled in that if they're insured. And then sometimes we have people who have insurance, so they are not eligible for pharmaceutical assistance programs, but their insurance, you know, there's issues. So, occasionally we have a prior authorization problem. Or if someone has Medicaid in another state and there's like little caveats. But I think medically, we feel very comfortable with this approach.

Dr. Mayer: Yeah. No, I think what you said very ‑ I would endorse everything you said, which [00:59:00] is that the medical part is the easy part. It's the insurance. But I think that's a cautionary tale for everybody listening today, is just, as you initiate these programs, to be talking with the companies that make the medications because there are access programs. Talking with your state health department or city health department because there are ways to figure this out. And then it's having dedicated staff. And, you know, that's sometimes harder in a smaller practice. But having, you know, [00:59:30] whether you call ‑ whether it's a case manager, whomever, there's some people who will know who, you know, will have the Rolodex of who to call basically for the different access programs.

There was one question, the chat before we wind down. What is the first‑line medication, and what if it didn't seem useful for the patient? In terms of first line, I think our message today is that there are multiple options and that, you know, different meds will be better for different patients. Some people don't want to take pills, and some people don't want to have [01:00:00] shots. And all of these modalities work as PrEP, and we now have data that says that they can work as same‑day PrEP. So, I don't think there's one first line, but again ‑ and I believe the slides will be available, you know, from Decera Clinical Education and I think that they're ‑ they're, you know, the table, one of the tables that Dr. Rowan showed really showed that there's, you know, there's some specifics for certain populations where we don't have data [01:00:30] on ‑ on some things like TAF/FTC, you know, for on‑demand, we wouldn't recommend that, for example.

But ‑ but really everything that we use for PrEP can be used for same‑day PrEP, but it has to be for the right population. And if it didn't seem useful, we monitor people. But again, fortunately, there are very few PrEP failures. I think that's really the take‑home today as well. But certainly, it may not be useful for a patient because some patients get nausea, for example, on [01:01:00] tenofovir‑based regimens. And so, that may not be a useful medication for them because of that side effect. But then they can get injectable medications. So, a lot of this gets back to, sort of, you know, having some understanding of the different PrEP medications and then trying to fit the right medicine for the right patient, the right situation.

Any last comments that you'd like to make, Dr. Rowan?

Dr. Rowan: No, I think we covered a lot, and we're right at time. So, just thanks everyone for your attention and [01:01:30] participation today.

Dr. Mayer: Thank you.