All right, I think it's time for us to go ahead and get started. Welcome everyone to today's webinar on depo subcutaneous administration outside the clinic. We are really pleased to have our fabulous panelists with us today and to have a chance to dive into this topic a little bit more. And I think we can dive right in. Next slide, please. Here's our overview of what you can expect today. In addition to giving you some background and sort of grounding in the evidence in terms of why this topic is important to us and something that we wanted to focus on today, we're also gonna spend a little bit of time talking about practical applications and implementation logistics. So we're looking forward to sharing those details with you as well. Next slide. Here are our learning objectives. As you know, the society is now able to offer continuing medical education units for these sessions. So if you're interested in obtaining those credits, you'll see a link at the end of the session for submitting your evaluation and getting CME credit. And next slide. And finally, I wanted to share a little bit before I turn it over to our fabulous panel about both why this was important to us and some of the things the society is doing to further this work. The first was a finding we had from our study, family planning visits during the COVID-19 pandemic. One of the questions we asked in our in-depth interviews at the very end of the study was, what's one change you wish you could have made during the pandemic, but you were unable to? And the most frequently cited thing was initiating self-administered depo. And it was fascinating to hear that as folks kept saying it was just too hard to get off the ground, there were just too many barriers. And so one thing we're really hoping we can highlight today are some of the practical and logistical steps that you can take to make that possible. We're also excited to have a forthcoming committee consensus from the society that talks about and endorses this option for patients. And then lastly, we're very excited, my colleagues and our grants team here at the society have a new funding opportunity. So you'll see the title of it here. It's In Their Hands, Exploring the Potential of Self-Administered Injectable Contraception. Applications are due in about a month. You can get more information by emailing grants at societyfp, or you can actually schedule a call directly with our director of grants, Jenny O'Donnell. Links for all of that are in the chat right now. We'll post these again one more time at the end of the call in case you need to follow up with my colleagues with more questions. And lastly, I'll say this is also being recorded as you may have seen when you logged in for, it will be accessible in our continuing education program, which is on our website. And you can also obtain CME credits for watching it in its recorded format. And there is also the option to turn on or off live transcription for your own accessibility needs. And with that, I am very pleased to turn it over to our moderator for the day, Julia Cohn. Julia, you're muted. That's so classic. So it wouldn't have been a good webinar without that, right? So thank you, Mary, and welcome to everyone, both those of you here live today and those of you who we hope will review this as a recorded webinar later on, should it not fit your schedule. I'm Julia Cohn and I am affiliated with Planned Parenthood of Northern, Central and Southern New Jersey, but I was formerly the National Director of Research at Planned Parenthood Federation of America or PPFA. And that was when I became mildly obsessed with our topic today. Today I'm speaking with you in my capacity as an SFP fellow. As Mary said, I'll be your moderator today. And we are so lucky to have two great speakers to share their experiences with you on this topic. First, you'll hear from Dr. Anita Beasley. She's an Associate Professor at Baylor College of Medicine in Houston and also Associate Medical Director for Planned Parenthood Gulf Coast, which serves both parts of Texas as well as Louisiana. Maybe she'll talk about that a bit. And then we'll turn it over to Dr. Jennifer Russo, who is Vice Chair of Clinical Affairs at Harbor UCLA Medical Center and also the Media Editor for Contraception Journal. So listen to those podcasts. And then we'll have some time for Q&A, but of course, please do feel free to put questions in the chat throughout, but we will take those at the end. Next slide. But before I turn it over to Dr. Beasley, it wouldn't be me if I didn't start with a couple of existential questions. Why are we here? Where are we going? And as I mentioned, it was during my time with the wonderful research department at PPFA that this issue really caught my attention. And it did because it came directly from a Planned Parenthood affiliate on the ground. They had high demand for depo from patients in their area. And they also had some onerous restrictions that required trips back and forth to the pharmacy in order for people to get their depo shots. They knew there had been some research. And so they asked, can't we just teach patients to self-administer? And as we all know, folks on this call know, people give themselves injections for things all the time, insulin for diabetes, infertility shots, other things, why not depo? And so we said to that affiliate, let's do it as a study and let's do it together. Let's find some money, which is the goal for all of us, and do the largest randomized control trial to date that's powered to detect whether those randomized to self-administration actually continue more than those who have to return to the clinic by the end of one year. And that's exactly what we did with 400 women, including some teens. And again, with the amazing research team at PPFA, along with Anitra Beasley, who you'll hear from today, Elizabeth Talmont, my wonderful colleague, and Carolyn Westhoff. And I wanted to say just a moment about the difference between self-administration and what Mary was very intentional to say about outside the clinic setting. And that is because we want this to encompass not only teaching people to self-administer themselves, but if we were in a room, I'd say, how many clinicians have had a patient say, my nurse, my aunt is a nurse, can't she just give me it? My sister's a nurse, can't she just give me it? And so we really wanna broaden ourselves today to thinking about it outside of the clinic setting with not necessarily holding ourselves or tethering ourselves to that patient, giving them their own injections. And that will come up throughout today. And so the rest you'll hear about shortly, but we certainly did that study, you'll hear about it. And we did not invent the idea. There had been some really incredible foundational work that Anitra is gonna tell you about. And in terms of where we're going, not just in terms of depo administration in general, but also in the larger sense of advancing health equity by reducing barriers to care and sharing power. That plus a movement toward more self-care, and by that I mean in the clinical sense, really brings us into this moment. And before we move on, I just wanna remind us all, and we can talk about this in the discussion or questions should it come up, that contraceptive continuation isn't the holy grail. There are many patient-centered outcomes that matter. So with that, I'll turn it over to Dr. Beasley. Next slide, please. Again, it wouldn't be a webinar if we couldn't figure out how to take ourselves off mute. As I always say, you think like years into the pandemic now, things would be smoother, but clearly not. All right, but anyways, so thank you. As you were saying, we've all had our own journey to why this research is important to us. And mine was at the Family Planning Fellows presentations the year before I started my fellowship. So someone must have been presenting on DMPA. And at that moment, I knew I wanted my project to be on administration of DMPA outside of the clinical setting. I remember jotting it down on this, and I had already developed this plan before I started fellowship. And at the time, I remember telling my friend who was an anesthesia resident at the time starting her pain fellowship about my project idea, because I just thought it was so wonderful and exciting. And as someone who regularly gives herself injections for her MS, she promptly told me my idea was ridiculous. She couldn't understand why we needed to study a medication that was already proven to be safe and effective simply so that patients could give it in a way that was commonly done already. So while I'm thrilled that we are having this webinar today, it really could have happened years ago. As Julia said, Depo-Midraxine Progesterone Acetate or DMPA is not new, nor is administration of injectables outside of the clinical setting. So onto the background. As we know, DMPA is a progestin only aqueous suspension injectable contraceptive with global and domestic appeal. It's effective for more than three months and it's completely reversible. It's been available from various manufacturers for more than 40 years. Historically, it's been administered via an intramuscular injection, but in 2004, the US Food and Drug Administration or FDA approved Pfizer's new formulation of DMPA called Depo-Subcuprevera 104, making space for self-administration. So at the time or at this time, DMPA-SC is indicated only for administration by a healthcare professional. However, the same formulation with a different delivery system is indicated for self-administration outside of the United States. So just in case someone from Pfizer is listening to our webinar, we would like the same indication here in the United States. So just saying. But anyways, regardless of delivery mechanism, self-administration of injectables is safe and feasible, and it's been demonstrated with other medications, including like what we all know, for diabetes, migraine headaches, allergies, fertility issues, and like my friend, for MS. So also as part of the 2019 Guidance on Self-Care Interventions for Sexual and Reproductive Health Rights, the WHO recommended that self-administered injectable contraception should be made available as an additional approach to deliver injectable contraception. The CDC adopted the WHO recommendation for DMPA in the new U.S. Selected Practice Recommendations that came out earlier this year, states that self-administration of DMPA-SC should be made available as an additional, not the only, as an additional approach to deliver DMPA. And although, like I said earlier, the FDA label states that it is only to be administered by a healthcare professional, we all know that we can prescribe FDA-approved drugs for off-label use, and this includes how we administer a drug. So using a drug that says it should be administered by a healthcare professional, teaching a patient to do it, so administering the drug in a different way, when it's medically indicated and as determined by the healthcare provider. Next slide. I think we might be having a brief technical issue. Just give us one moment. Okay. And I can go ahead and talk just a little bit. I don't think that, you know, all of the background because it's stuff that we already really know it's gonna take that long, but also my slide is not so fabulous. So if we get through it without it, that's also okay. So the first thing is that the intramuscular and the subcutaneous formulations are way more similar than they are different. So there were two large pivotal phase three studies of nearly 2000 women and over 16,000 DMPA SC exposure cycles that resulted in no pregnancies demonstrating comparable efficacy between the intramuscular and the subcutaneous formulations. And additionally, in those studies, it showed that undesirable side effects such as irregular bleeding and weight gain were similar between the two formulations. See, now I told you the slide wasn't all that interesting, but there are differences between the two methods possibly and most importantly, and this is really something I had never considered, but it really is important until I started kind of preparing for this. It should be highlighted that while the active ingredients for DMPA are the same, for the SC and the intramuscular formulation are the same, the subcutaneous formulation contains 70% of the active ingredient and is a different formulation than the intramuscular. So that's why we have 150 milligrams per milliliter of one, and then 104 milligrams per the syringe, which I believe is 0.65 milliliters. And so it should not be overlooked that a smaller amount of the intramuscular formulation cannot be injected subcutaneously and still be effective, and conversely, the subcutaneous formulation is not injected intramuscularly. So as we also know, more skill is needed for administration of intramuscularly delivered medications, and so they are not commonly administered by non-healthcare professionals. Thus, the continuous use of the intramuscular formulation requires multiple clinic visits each year. And subcutaneously delivered medications can easily be delivered outside of the clinical setting, and this results in saved time, cost for travel, cost for childcare, et cetera, and separately, also cost savings to the healthcare system. And because the subcutaneous form comes in a single-dose pre-filled syringe, it eliminates possible medication errors that can occur when drawing up from a single- or multi-dose vial. There are, or users of DMPA-SC are more likely to have injection site reactions than the intramuscular formulations, but they tend to be generally mild and quickly resolved. Next slide, please. So it seems that we're back to what we already knew. DMPA is not new. The subcutaneous formulation has similar efficacy and side effects as the intramuscular formulation, and many medications are safely and routinely given through the subcutaneous route outside of the clinical setting. So I probably could just stop here and say, you know everything, let's go, let's do sub-Q Depo-Provera, but then Mary might be mad at me. So there must be something different about DMPA-SC. So in my mind, the unique questions that surround administration outside of the clinical setting are, one, is there patient interest in this delivery mechanism or route? Two, is self-administration feasible and easily taught, especially with patients who may not be accustomed to self-administration and with a medication that only needs to be delivered every few months? I think there is a big concern that the skillset or whether the skillset will be remembered and will it be reproducible every three months? The other thing, is the medication safe when given outside of the clinical setting? And can it be restarted after discontinuous use? So are we going to have a lot of patients that are unintentionally becoming pregnant because they're stopping and starting as patients really do with lots of different contraceptives? And does it improve continuation? That was a lot of hands. But as Julia said earlier, continuation isn't the end all be all, but it's something that a lot of people do want to know. Next slide, please. So let's kind of look at these different categories one by one. So interest and acceptability of self-administration of DMPA has been studied since the development of the subcutaneous formulation. And as a reminder, it was FDA approved in the United States in 2004. And time and time again, studies have shown that there is patient interest in DMPA outside of the clinical setting. So let's dive in. So LAFCA et al used self-administered questionnaire to query patients attending a large family planning clinic in Edinburgh. And these were patients who were coming in for repeat DMPA injection, so already intramuscular users. They were asked if after appropriate instructions, they would be interested in giving themselves a injection every three months. 67% said that they would like to self-administer DMPA. Of those who did not desire to self-administer, the most common reason was a fear of needles and concern that they would administer the contraceptive incorrectly. And then several months later in the same clinic, they administered a similar questionnaire to all of the patients, not just the current DMPA users. Of the never users, 26% said that they would seriously consider DMPA if self-administration was possible. And this was surprising to the authors that it showed the promise of self-administration and reduction of clinic visits and increased acceptability of DMPA, both in patients who have never used it and in those that have tried it, but discontinued the method, especially when we realized the most common reason for discontinuation is not normal, or patients don't normally say it's because of all the visits. They really normally talk about the irregular bleeding. So would self-administration make the irregular bleeding something that's more acceptable? And that's a question that hasn't been answered, but Patia et al analyzed two surveys on contraceptive attitudes among family planners and family planning in abortion clinics. And overall, 21% of patients reported interest in self-administration. Patients currently or formerly using DMPA were more likely to have an interest in self-administration than patients who had never used it. And then patients who reported difficulty in obtaining or refilling a prescription of any type were almost twice as likely to have interest in subcutaneous administration as patients reporting no difficulty. And the interest was primarily driven by a desire to eliminate unnecessary return visits to facilitate a repeat injection. And then Pat's et al, this really is more of a project implementing subcutaneous DMPA within the context of the COVID pandemic, but it can also inform the feasibility aspects as it speaks to real world uptake of where we are right now. And the previous studies that we just talked about were questionnaires and more theoretical in nature. So in this study, non-pregnant patients at an urban safety net hospital based primary care clinic who had been prescribed intramuscular DMPA in the past were contacted to gauge entrance in self-administered DMPSC. Interested patients were given a, received a prescription for the subcutaneous DMPA and a telehealth appointment to learn self-injection. So 37% of the patients contacted expressed interest and scheduled a telehealth visit to learn self-administration. And then of the patients not interested, the most common reasons were fear of injection, wanting to stop DMPA in general and satisfaction with intramuscular administration. Next slide, please. All right. So let's talk about feasibility. So when you're thinking about feasibility, there are several critical implementation elements to consider with administration of DMPA outside of a clinical setting. This includes instruction, which can be either in-person or through telemedicine of self-injection or having someone else inject for you, sharps disposal, access to follow-up care for questions or to switch administration types or another contraceptive method, re-injection reminders and administrative issues such as ordering, billing and reimbursement. So Cameron et al was a pilot study to determine the feasibility of self-administration in established DMPA IM users. Participants were taught how to give a subcutaneous injection by a study research nurse using an injection teaching model of artificial skin on a belt that can be worn on different parts of the body. When the patients were deemed competent, they gave themselves the initial injection under supervision and provided, were provided with three additional pre-filled syringes and then written information on when the next injection was due, information on self-administration, safe storage of the medication and sharps disposal and a 24-hour contact number. And at the end, 90% of patients agreed that self-injection was easy. The vast majority of injections were given during the scheduled window and only 1% of injections required an unscheduled clinician supervision during the study. And so Beasley et al, I'm like, that's me, I'm gonna dive, as I was preparing for this, I showed my daughter, I'm like, look, this is my article. She was so unimpressed. But anyways, this was the first randomized trial comparing DMPA continuation between in-clinic users and outside of the clinical setting. And so participants in our study were used, we wanted to find something that was going to be very, very, very easy to replicate and do. So we actually just used modified illustrations from the prescribing information and gave that information to the patients. And then they were observed and giving themselves their first injection. If successful, they were provided with DMPA for home use and then similarly given information like in Cameron et al, but they were also given information on how to restart depo outside of the dosing window if temporary discontinuation occurred. And this was via the quick start method. And so all participants were able to successfully self-administration. Most injections were given within the dosing window and participants who desired to restart were able to do like, again, via the quick start method. In patients who reported continuous use, we also checked with MPA levels and they were all within the therapeutic range. As Julia talked earlier, this is her study. They did a larger, also randomized trial comparing continuation with self-in-clinic administration of DMPA-SC. The clinic staff taught participants, or the clinic staff taught participants who were randomized to self-administration to self-inject using similar methods and then observe the first injection. And self-administration patients received instructions, a sharps containers, three doses for home use and others received usual care. And then text or email reminders were employed for those in the self-administration group. Not on this slide, but for CATS et al, which we previously considered, patients were educated, it was a reminder that patients were educated via telehealth in the context of the COVID pandemic. And so 58% of those interested successfully were able to self-inject and the ones who were not encountered barriers, not so much to receiving the information, but a lot due to prior approval for the Depo-Provera and losing health insurance. Next slide, please. All right, guys, we're almost done with this part. So when we're looking at safety, we've learned that subcutaneous DMPA has similar rates of pregnancy, side effects and adverse events equivalent to those associated with provider administration. And so let's dive into this for just a little bit. So DrugMon and Gaffield conducted a systematic review to evaluate the peer-reviewed literature and the safety of DMPA-SC among patients with various characteristics or medical conditions. And so they found that the evidence for use by women with select conditions and characteristics, including age, obesity, endometriosis, or HIV, demonstrated that this method could generally be used safely in these contexts. And then that the SC and IM formulations were appeared to be therapeutically equivalent with similar safety profiles when used by healthy women. So again, what we've already known. And then Kennedy et al performed a meta-analysis of existing evidence comparing patients who received injectable contraception with the option of self-administration to those who received provider-administered injectable contraception to generate a pooled evidence of relative risk. And there were only six studies that met inclusion criteria, including mine and Julia's study that met the inclusion criteria. So four studies reported pregnancies and all showed no differences across the study arms. Four studies also reported side effects and adverse events. Two of those studies only showed increased injection site reactions, but no other adverse events that were different between the groups. And then one study looked at social harms and found no social harms. Next slide, please. So this is just a closer look at the Kennedy study we talked about on the last slide. And it split up from the randomized trials from the observational studies. And so with respect to continuation, the meta-analysis found a higher rates of continuation with self-administration compared to provider administration in the randomized trial. Next slide. And now we are looking at the meta-analysis results from the observational studies. And from these studies, it was remarkably consistent with the randomized control trials. Self-administration was associated with an increased likelihood of continuation at 12 months compared to provider administration. And so the authors conclude that a growing body of evidence suggests that self-administration can equal or can have either equal or improved continuations rates as compared with provider administration. And then this benefit comes without a notable increase in pregnancy or safety concerns. Next slide. All right, so the bottom line, it's kind of like what we knew from the very, very, very beginning, but I do appreciate you staying with us and sticking around. DMPA-SC administration out of the clinical setting can improve continuation, access, autonomy, and continuation and is feasible and acceptable for adult and adolescent patients. It should be made as an additional approach and provider administration should remain available. It should be offered in non-coercive, patient-centered, equitable manner as part of access to the full range of contraceptive methods. So that's it. Next slide, please. Unmuted now, watch that. So thank you so much, Anitra, and we're gonna move on. That was a tour through this sort of evolution of the evidence, and some of you don't know all of that, nor do we expect you to read every single study. So that was a fantastic summary, thank you. Next, we're gonna move to Jennifer Russo, who is going to talk about from research to implementation. So you heard before Mary say that a lot of folks that responded to their surveys wished they had implemented DEPO self-administration or administration outside the clinic, but didn't. And the most commonly cited factor was it was too hard or there were too many barriers. So I know that not everybody is doing it, but certainly some are, and here's one. And welcome, Jennifer Russo, to talk a little bit about your real-world experience. Next slide. Thanks, Julia and Anitra. That was a great introduction, and I feel like I've read these studies multiple times, and every time I hear about them, I learn something new. And Anitra, I really like how you presented all of that data, so thank you. Also, joining in the trip down memory lane, I too, in 2010, when I started fellowship, thought, why aren't we doing this? It's been around now for six years. People should be using DEPO at home, and received the response, well, we don't know about safety and effectiveness with home use. So those studies need to be done, and I said, that's not gonna get done in my fellowship, so I'm going to skip it. But then what happened, and you can go to the next slide, is COVID. And at the beginning of the pandemic, we had a big discussion about how we could expedite access to contraception or prevent barriers to contraception. And just to give a little background, I work for LA County Department of Health Services. I work for Harbor UCLA Hospital, which is one hospital in the system, which has 26 clinics and four hospitals. At Harbor, we have two women's health, essentially, gynecology clinics, and the hospital setting. And so at the beginning of the pandemic, we said, how are we going to potentially reduce barriers to DEPO? And like many providers, we had a discussion about express visits, patients coming through the parking lot, and having a provider run out to them and give them their IM shot. And at that moment, I came back to my distant memory of fellowship and thought, why don't we start doing sub-Q DEPO? Maybe the barriers are less now, and we have a little more leeway, which is, I know, the same as many providers. However, the thing I'll say is that if any of you are familiar or work in a county system, it is a very, very slow-moving system. So while my data, which I literally just analyzed a few days ago, and I'm sharing with you now, may not seem like it is extremely impressive, it's very impressive to me because of how hard it is to change the system. So a few things. We have this large system, and we have many different providers in the system. This is a comprehensive health system that has many primary care providers, gynecology providers, and various settings and sites and people who have varying levels of, let's just say evidence-based practice. And so we really understood that there was gonna be a challenge in rolling this out. We also, and this came up in the CDC discussion for the selected practice recommendations, wanted to be conscious of providers' overall feeling about DEPO and potentially their implicit or explicit biases about the medication. So that was one thing that we wanted to examine. We basically, what we thought about doing was sort of a plan-do-study-act cycle where we would pilot the administration of the medication or the change in the system at one site and then potentially roll out to all sites. We did that for those reasons. And also in addition to Title X changes and the loss of Title X in the county that decided not to participate in the program. And as a result, the loss of 340B pricing for our outpatient centers. And so without getting into lots of details about that, this would, with a larger rollout, it would have been extremely costly for the system. And then also we, yeah, so I'll move on from that. So basically how we did this was that we created a webinar that detailed the evidence up to that point and talked about how we then could adapt the practice to our setting and gave instructions on, I had worked with the pharmacy on the prescription, the prescription in our EMR, how that would be then carried out by the pharmacy, instructing providers that the patient needed to go to our own pharmacy and should not go to outside pharmacies, which number one, may or may not stock the medication. Again, as Anitra pointed out, might require a pre-authorization, or even if they did stock, it would then charge the DHS system significant amounts of money for it if we didn't keep it in-house. The other thing is that our outpatient pharmacy in DHS offers mail order. So the pharmacy themselves made the suggestion that patients should be told that they should get their prescription in person and then immediately request mail order at the pharmacy and get their next dose sent to them when they give themselves the dose. And so that came straight from pharmacy. So there was a lot of collaboration. And we also created a video for patients. So let me talk about the provider survey first, and you can go to the next slide. So this is just a sampling of some of the questions we asked and you can see that this was only 10 respondents. So it's not like this very large survey. It was mostly our providers at the pilot site, which was at Harbor, UCLA. But I think it's interesting nevertheless. We asked folks, so this was to get a little bit at biases. It doesn't get at it directly, but it asks providers. And this was the idea of a resident that I was working with on this. She suggested that we ask if people would use Depo themselves. She was just curious. And interestingly, those who said yes, more said at home, and that was three of the group. And one said yes in clinic. And six said no. So we can extrapolate what that might mean for their counseling. You can go to the next slide. And then we asked folks if they were aware of the subcutaneous formulation of Depo prior to watching the webinar, and three out of 10 were not aware. So again, I think that's also interesting since it's been around for so many years that providers have just not been aware of it, I think. You can go to the next slide. And then we asked, regardless of mode of administration, sub-Q versus IM, how comfortable do you feel offering Depo as a contraceptive method to patients? And I thought, although there were a lot of very comfortables on this, I think it's kind of interesting the skew that it's not exceedingly towards the very comfortable side. And that helped, you can go to the next slide. So I've always, kind of throughout my practice, I've had a concern about variations in counseling and really feel like video works very well for some counseling that's standardized. I know people could have lots of different feelings about this, but my personal feeling is that creation of a video allows for scalability and allows for consistency across counseling that you can make sure that the patient heard the information that you would like them to hear and may kind of limit some of that bias. So we decided to create a video with instructions. I did this with a resident as well, and the link is in the chat. And this just, it's a five minute video in English and like a seven minute video in Spanish that goes through instructions on use and demonstrates how to give a subcutaneous injection. At the time that we created this, it did exist on the Bedsider website, but it was a link to an endocrinology, like it wasn't about depo in particular. And we really felt like we wanted to have depo specific instructions, even though it's the same as any subcutaneous injection. And so the workflow is that the provider sees the patient, if they're expressing an interest in depo, they offer for them to do subcutaneous use at home, either with themselves delivering it or a family member or a friend. And if the patient says, absolutely not, I will never give myself an injection, then they're done and they move to IM depo. But if the patient says, I might consider it, how do you do it? The provider then says, here, go to YouTube, Google or search on YouTube, Harbor UCLA depo provera. It comes up and then they watch the video, the provider leaves to chart or do whatever and comes back when they've concluded the video to see if they're still interested. You can go to the next slide. So we looked at our results and by we, I mean, I looked at results from July until September, 2021, fresh off the press, you can hit next. So at our pilot site, this is what I found, you can hit next again. We did 40 depo subcutaneous initiations and 614 depo IM initiations. And this is at the hospital and then two clinics. And so this is less than 10% of patients took advantage of subcute depo, but that isn't, it's not known whether uniformly patients are being offered it. And I don't think that they are. So this being less than 10% points to me that we have a lot of capacity here that we need to build in offering patients depo and we need to do more education. Next. Then I dug into the 40 charts and actually reviewed all of them just to see what the situation was and found out some really interesting things. First of all, of 40 patients, 23 continued to use subcutaneous depo or refilled their prescriptions, 14 stopped and three were not applicable because they literally just got prescribed in the last three months. So they don't count. But in the 14 that DC depo, there are a couple of issues. Two of those patients were sent to outside pharmacies and couldn't get the medication and called us repeatedly. And then the providers didn't realize that it wasn't supposed to be prescribed to outside pharmacies. And so there's, that's a education point as well. And I made sure then that those patients were called and offered to go to the Harper pharmacy. In addition, surprisingly a significant, because there was actually most uptake at our primary site in the hospital, in the residence and faculty clinic here. And it was being used a great deal for patients with abnormal uterine bleeding. And so it was less for contraceptive purposes and more for medical purposes. And many of those patients discontinued because they went on to have a hysterectomy or change to a levonorgestrel IUD. And so just point of interest, you can hit next. So then I asked the pharmacy to pull all of the prescribing across all DHS sites. And so there are 26, there are 30 clinics and tertiary care centers, but only 16 have actually prescribed it. So we only reached half of the entire system and you can go next. There were 281 initiations across all and next. And what we found was that I was really impressed actually that one of the sites that I have never been to physically and wasn't sure that this information had reached them, it actually had and they had just as many initiations at their site as ours. And so really, and then when I looked at the distribution of where the greatest use was, it was typically at sites where folks had had some contact with the webinar and with me or other members of our department who were advocating for the use of the medication. Like for example, I think a couple of the faculty who work at outlying sites spoke with the residents about it and prescribed it when they took call at the hospital and then went back to their centers and prescribed it to patients. So there's a lot of work for us still to do and, but there are a lot of lessons learned from this initial rollout. And I think that if we can do it in our system, which is a very, very large system, then it can be done anywhere. And I think now that we've laid the groundwork, we're gonna be able to expand on it. And the only other thing I would say is that for those of you who are interested in models for rollout, first of all, feel free to use our video with patients. I can't share the webinar that we created because it's internal, but the Katz and Carlin article at all, we did a profile of that on the Contraception Podcast. You can look in the archives of the podcast or I can add the link to the chat if you're interested. That goes over their rollout at UCSF and provides resources and videos and handouts, et cetera, if you're interested in implementing. And I think that's the last slide. Thanks very much. Happy to take any questions. Thanks so much, Jen and Neetran. I think we intentionally wanted to leave some time for questions, so please do feel free to put those in the chat. I've listed our contact information here as well as the grants information because sometimes that contact slide goes way too fast and no one sees it. I also wanna acknowledge that this slide begs for a picture, particularly on the left side, but I've learned over my years of working in this field that pictures of needles can be trauma cues for some people. So I no longer show pictures of needles or pictures of people giving themselves injections unless they want me to. So a couple of things that I wanted to just, as we're waiting for questions to come in, and I have some questions for you folks myself, but a couple of just themes I wanted to pull out here and things I wanted to mention. So one of the things that none of us explicitly mentioned here, so first of all, a number of the studies that Anitra and Dr. Beasley talked about are international studies. And I wanna really acknowledge that for folks on the call who may be more interested in international healthcare, et cetera, that there's tremendous work on this being done in particularly in Africa and also in Latin America. And I wanted to just call it out that because none of us hit on it, because we don't have it, that there is a dedicated product that in many places, including in Europe, that is actually labeled for self-administration that was created for that, that's used in a Uniject distribution system that looks like kind of a cute little bubble wrap thing. And some of you may know it as Cyanopress. We generally don't talk about brand names, but I think it's just behooves us here because so many of you have heard of that. And we don't have that here in this country. And unless someone knows something I really don't know about the pipeline, we're not looking at it anytime real soon. And so right now in the United States, we have the product we have, which is a sub-Q delivery system that as you've seen from all of this research is interesting, feasible, let's see, safe, and also as a continuation, but that is not specifically labeled at this time for that. And so I just wanna acknowledge the amazing work of PATH and other organizations that are doing this work internationally. They've got a different environment to deal with and yet a different product that's kind of dedicated. And so you can sort of see some ups and downs there. I also wanted to just quickly acknowledge that there was an awesome SFP session on this same topic. So for those of you who did go to the conference and still can tap into those recordings, I really encourage you to watch that. Also mentioned was the selected practice guidelines or recommendations. And just for people to be able to read those themselves, we can circulate some resources after that. And NIFRA, for those of you who are NIFRA members, and it may actually be on their website itself, if so, we'll post it, did some really nice resources on this too to try to enable implementation. And finally, I just don't wanna miss out on acknowledging the whole sort of area of gender affirming hormone therapy for which there is both great overlap and sometimes not overlap with some of the work that we're doing. But some of the really incredible work that's been done in that space, and you can imagine they've got some awesome videos before we thought of videos because they had to. And so just really acknowledging that overlap with that clinical space as well. So I see some questions here. I have a few of my own, but let's see. Question, Jen, can you talk more about what is covered in the video? Does it serve as a full kind of how-to step-by-step that patients can reference when they wanna do their injections later or more of a general counseling video? Yeah, great question. It's actually both. It provides background information on what to expect with Depo and effectiveness and risk benefits. And then it also is a step-by-step guide on doing injections that actually one of our residents, Bailey Pesterov, recorded herself giving herself an injection. And it's very simple. I think it's fairly non-traumatizing. Like she does it very simply and easily. And so, yeah, so it's both. So the patient, so the benefit of that, I think is that the patient receives all of the information that we wanna provide a patient when they're starting a method as well as how to do it. Great, thank you. And Jenny asks, can the panelists speak to demand for self-administered DMPA and how it might vary between subgroups? How, if at all, might the actual or perceived demand shape clinical providers and systems willingness to offer the service? And I'll just speak to that quickly, which was part of my, part of the, or sort of a sub-question of our study was to think about that from provider's perspective. Oh my gosh, are all of these depo patients that I see every single day, all of a sudden gonna wanna self-administer and I'm gonna have to stop clinic and I'm gonna have to train every single one of them. And now I'm gonna have to follow up with them and answer their questions when they forget how to do it and all of that. And I think both the observational studies that are survey studies that were hypothetical that Anitra talked about, and then our actual studies, I don't have the numbers in front of me, in terms of acceptance rates, which of course is about acceptance into a study as well. But show, don't worry, you're not gonna be completely overrun with people who wanna self-administer, but there will be a population that are interested in that. And if not offered, they'll never have the opportunity. So Anitra, I'll let you speak to that for what it was like in your study, which was done. We didn't say Anitra's study was done in New York, where I live. My study was done in Houston, where she lives, and also in New Jersey, which is close enough. So Anitra, what was your experience? Yeah, I'd say uptake was, I'd say specifically for the study we did in New York was better than expected. And, but I would also say, like you said, that has to do with doing research and also compensating patients for their effort for being in the study. But clearly it wasn't everyone. There were definitely patients who just were not interested. And so there will be patients who are not interested. Depo-Provera is not the medication for everyone. So there'll be reasons why they don't want to take it. And then self-administration or administration outside of the clinical setting is just not appealing to some people as well. But I would say for the second part of the question, how would actual or perceived demand shape willingness to offer the service? And I would say, while it's important as you're thinking about the resources that you need to be able to train patients and how you're going to follow them up, it's not something that we also think about with all other medications. And if that were true, we'd only have one type of, you know, combined oral contraceptive, but we've got, you know, a kabillion. So no one's like, well, you know, I was like, oh, are we going to do that one with the such and such hormone? Well, no one's ever going to take it or we're not going to change, so we're just not going to do it. So, and as we all know, the best type of contraception is going to be the one that the patient can use and wants to use. So, you know, I advocate for it being as available as possible. All right, so then I'm going to ask you both the question and then we'll see. Why then, and Jen, maybe you want to start. Why then do you think that so few providers are offering this to patients at this time? Jen, come off mute and give me your first thoughts. At a moment of thinking. Well, first of all, the thing, one thing I was, there's a question in the last question about subgroups also, and I'm assuming that somebody's asking about demographic information. And for me personally, I don't have that information, but anecdotally speaking from looking at the charts, the group was very representative of our patient population in general, which is largely that, you know, we serve a Medicaid population in Los Angeles. The population is largely Latinx and that was pretty consistent. With the users, but we could do that sub analysis. I would say the reason is that people don't like change. And just like Anitra or Juliet, you were saying, you know, people think I'm going to have to sit down and talk with a patient for 10 minutes about this and explain this whole thing, which really, you know, I mean, unfortunately, given the situation, you know, with public health in this country, most people know somebody who delivers their own self-injection of insulin or some other medication. Like it's not a mystical thing to people at all, has been our experience, but that's it. I think it's people's fear of having to explain this whole long thing. So hence the video for us. I would say it's just not as easy as some other, you know, medications that are in your pharmacy or in the pharmacy that the patient can go pick up. You don't have a drug rep that's coming and saying, hey, you may have been doing IM, but now we've got SC. So here's how you do it. And so it's like, it's for a lot of providers, it's just as easy to do, you know, what they've been doing than to change to something new and exert the effort to get that service out there. Well, I think, you know, both of those, and not that I have the answer, but just our wacky payer and drug pricing system in this country, which I will not go into, I promise. But I think, yes, it is complicated, but the fear of its complication is even worse than its complication. And formularies and, you know, just all of that is infinitely overwhelming to people. But I think that what would be great is if some of the studies that are funded out of, you know, this next grant cycle from SFP, which was mentioned at the top, could really kind of dig into some of those and really help, you know, people say, what would this really take on the ground? Because frankly, I would have done a giant implementation study if I thought the field was ready for it. Instead, I felt because of our system, our payer system, et cetera, we still need more randomized control trial evidence that this actually is feasible, safe, and improves continuation. And take that for what it is. But I think that we're in a great moment to really take this practice and really think about what it means for patients. So let me just bring us back there. We're talking about people, we're talking about patients, we're talking about people's lives and the time and the burden that it takes for them to return to the clinic when they have to be at work. We're talking about people who work on islands and have to go to clinics and take a taxi just to get a shot, just to get back on the ferry, just to get back to the island. We're talking about people who live in rural areas for whom they, you know, don't have transportation or even non-rural areas. So we're talking about people and we're talking about trusting people. And I won't say women, I'll say trusting people and trusting families to take care of their health the way they want to. So I want to, again, thank Anitra and Jen. And I'd love to just kick it back to Mary, if I could, just to remind folks where this will be housed, additional resources. If there's a place for us to give you stuff to put there with it, we're happy to. But I just want to say thank you so much to Jen, to Anitra and to Mary for organizing this. I had my own unmute struggles. I want to echo my deep appreciation to this group for coming together and putting together this incredible resource, both for our folks who are able to join us today. And as we mentioned, this will be a recording now. And for those of you who haven't had a chance to explore our continuing education resources, all society members have immediate and free access. This will take a few days to be posted, but once it's up, you'll have access to a full breadth of content related to both this session, you'll see the recording and some resources that the panelists mentioned. Also a link to the RFP that's in the chat here and also on the society's website. For those of you who are registered for this webinar, but not society members, you too will have access to those recordings. So you'll see the link where we shared that here in the chat. And that's also where attendees can claim CE credit. So your continuing education units are all linked to that evaluation. And we really appreciate your evaluation. It helps us figure out what we might do next and how we might keep improving for you. So all that to say, thank you so much to everyone who joined us today. Thank you immensely to our panelists, Julia, Jen, and Anitra. It's wonderful to see you as always. And I wish everybody health and rest in the coming weeks and months. Take care of yourselves and we'll see you all soon. Bye-bye.

depo-subcutaneous administration

self-administered depo injections

feasibility

safety

acceptability

subcutaneous formulation

implementation practical aspects

patient training

provider willingness