Title Slide:	Header: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Division of STD Prevention 

Remote Health Meeting [Virtual] May 24-25, 2021. [This meeting is being recorded. By joining, you are giving consent for this meeting to be recorded.]

	A meeting focused on optimizing delivery of sexual health (STI & HIV) services through communication technologies ranging from face-to-face in brick-and-mortar clinics to text messaging; its determinants and consequences including technology, regulation, reimbursement, coverage, equality and more...

	The meeting will include 3 talks, 2 panel discussion, 3 discussion sessions and a debate, as well as examples of implementation platforms

Raul A. Romaguera, DMD, MPH

Raul Romaguera:	Good morning and welcome to the remote health conference. My name is Raul Romaguera and I am the acting director of the division of STD prevention here at CDC. COVID-19 has challenged the system in many ways. It has forced providers to prioritize services, clinics to reconfigure office space and limit the number of patients. And it has also exposed inequities in access, availability and delivery of healthcare services. [00:00:30] COVID-19 has also encouraged innovation and advances in the delivery of health services, particularly in the use of electronic information and telecommunication technologies that allow providers and public health programs to deliver remote services and monitor patients by practicing social distancing. COVID-19 has also stimulated the development of new diagnostic tests that patients can use to collect their own specimens at home. These home-based tests provide privacy, address [00:01:00] persistent gaps in access to testing, and making testing more equitable. However, to implement this program successfully, we need to carefully review and if necessary update local and state policies and regulations, insurance coverage, and clinical guidelines.

	We also need to establish new procedures to report cases for local and state surveillance and develop new approaches to conduct case investigation, contact tracing, and linkage [00:01:30] to care and social support services. We in the division of STD prevention want to use this opportunity to launch an initiative to optimize the delivery of sexual health services through the whole range of information and communication technologies that can be used between health providers and their clients, from face to face communication in clinics to text messaging. This two day meeting is the official launch of this [00:02:00] initiative. During these two days, we hope to identify and establish a core group of people who are [inaudible 00:02:07] delivery of sexual health services.

	[00:02:30] And we also want to restart [inaudible 00:02:32] examples of platforms, [inaudible 00:02:43] of progress. Over these two days we want to establish [inaudible 00:02:55] publications. Because our goal today is to [inaudible 00:03:00], [00:03:00] we will not be taking questions on that. So we'd like to ask you it in the chat function. However, we want to encourage you to write down your questions, ideas, suggestions, and other topics that you would like us to explore in future meetings. And at the end of this conference, we will provide an email address where you can share this information with us. Also, because we don't have a meeting facilitator, we are asking all the presenters to introduce the next speaker. [00:03:30] We also have good news for those who would have liked to join [inaudible 00:03:36] HIV/AIDS prevention have informed us that we will be recorded and made available at a later date.

	Finally, I want to express my deepest gratitude to all the individuals who help us with this endeavor. Slide. Patrick Sullivan, Christopher Hall, Patricia Jackson. Change slides. Thank you. Patrick Sullivan, Christopher Hall, Jeffrey Crowley, Charlotte Gaydos, Jen Hecht, Julie Schillinger, [00:04:00] Sevgi Aral, and Patricia Jackson. And now I would like to pass it on to Patrick Sullivan, who will present the conceptual implementation frameworks. Thank you.

Slide Text: 	Conceptual and Implementation FrameworksPatrick Sullivan, DVM, PhDCharles Howard Candler Professor of EpidemiologyRollins School of Public Health

	Channeling the work of Dr. Sevgi Aral

Patrick Sullivan:	Good morning and thank you, [00:04:30] Raul. Thanks also to Dr. Sevgi Aral, for helping leading the convening of this meeting. And on my slide, I put I'm honored to present today, but really channeling the conceptual framework that Dr. Aral conceived of and developed. And the goal of this talk is just to get us to start thinking about both the conceptual framework [00:05:00] and also implementation frameworks. As you hear about different examples of types of tools or interventions, I think we want to be thinking about those in terms of where they fit in the bigger picture, and also implementation, not just in the specific examples that we'll hear about, but also thinking about the kinds of questions we have about different implementation settings and for different applications. So I'm just going to try [00:05:30] and talk through some of these considerations. And I'll start, even before we get to the first sort of substantive side to just expand a little bit on what Raul raised about COVID as a catalyst.

	And I want to recognize it, as you'll see, and I see some of the presenters here who've been doing pioneering this work for decades, on home [00:06:00] collection, home testing, and essentially, the remote provision of these services. And I think COVID really has just given us an illustration of how valuable it is to have these tools and to have options for different kinds of health services. So on the one hand, COVID was disruptive in that it created service interruptions due to the closure of physical locations. And in the cases where services really were only configured to be provided [00:06:30] in those physical health care provision locations, there was not a mechanism to provide those services.

	And even where those services were available, fears of attending healthcare clinics, and I think there's good documentation through survey work and measurement of resource, of utilization of services, that these really cut across a lot of the chronic health conditions that we're concerned about, including for people living with [00:07:00] HIV, for people on prep, for routine HIV screening, for routine STI screening. I think at the same time and even proceeding COVID, there's been a move towards tele-health and sort of direct consumer marketing for specific kinds of medications that we might say are for more sensitive conditions.

	And I think it's important from a patient perspective to think about where these kinds of services have value. And if you look at what's directly advertised on [00:07:30] TV, that you can have a short consultation with a physician and get medications delivered to your home, those tend to be for conditions that people may be less comfortable talking about in a traditional provider visit. For example, drugs for erectile dysfunction, hair regrowth drugs and treatment for herpes. And I think, I say this just to recognize that there's a patient perspective here about, and there are always these barriers [00:08:00] to entering care. And some of them may be about comfort and having a face to face interaction. And that may be more comfortable as a text message interaction or a Zoom interaction or a voice only interaction. There's also a proliferation of mental health services that are available.

	And so I think thinking about the participant perspective, I think there's also just a rise of the informed self, that there are more and more tools that allow people to assess their blood pressure, their blood sugar, [00:08:30] other aspects of their health at home. And it's natural that this should extend to sexual health, both in terms of screening and in terms of other kinds of preventative tools. Secular trends in the increase of coverage of smartphones, it's now true that I think between 85 and 90% of all adults over all people over 18 in the U.S. have a smartphone. And to a large extent, [00:09:00] the racial and ethnic gaps in smartphone ownership have declined. Where there is now a gap is an age gap, and it's towards older Americans being less likely to have a fully featured smartphone and more likely to still be using a flip phone.

	On the individual front, I also want to raise the issues of privacy and stigmas. And I think this particularly relates to people that we want to serve in rural areas. And we hear in [00:09:30] focus group discussions frequently that one of the reasons that people don't seek care locally in rural areas is because these may be small towns. There may be one clinic and one of your relatives or your neighbor's mom may work there. And there are just fears that if I go to that particular place to get care, word may get around. Why would I need prep? Why would I need to be tested for a rectal STI? And the other is the idea that the services that we're putting forward, prep, [00:10:00] recommendations for HIV screening more often than one time a year in some cases, make it challenging for people even in non COVID times to be going into health care visits so frequently.

Slide Description	The Dynamic Remote Health System: Determinants and Consequences (Credit: Dr. Sevgi Aral)

	The list of determinants link to a matrix of the remote health continuum of communication technologies such as health services, face-to-face, over the phone, telehealth (zoom, facetime), and asynchronous messaging, which in turn link to the list of consequences. The consequences link back to remote health as well as location, roles of different providers, and time and place flexibility. 

Patrick Sullivan:	And so the idea that maybe there's a once a year in person visit, but that the maintenance, the every three monthly things, can be done more remotely. I think some of our talks will get to this. So with that in mind, I start out with some of those patient [00:10:30] side considerations, simply because the frameworks that we have have a lot of ground to cover. And on the next slide, I'm going to share with you a conceptual framework, really built on a sort of determinants and consequences framework. And I credit this to Dr. Aral and I'll do my best to represent it. But we've already started talking about some of the determinants of these remote health systems. I've sort of layered in some of the patient side considerations. [00:11:00] But when we think about determinants of the systems, technology plays a big role. And I think this spans technology, everything from the technology of the tests themselves and the platforms to the ability to conduct tests with smaller volumes of biological material to the bandwidth of devices that people use to interact with providers.

	There's a big [00:11:30] space here for rules, regulations, and laws. And I think we'll hear some of this in the industry panel that will happen tomorrow afternoon, but certainly the regulatory frameworks that are in place in terms of the testing, the sort of laboratory developed tests that may represent modifications of the specimen requirements to operate in a CLIA environment, are [00:12:00] of great consideration as we think about how to try to innovate. The laboratory capacity itself is a key component, the security of these platforms, and how we make them robust to an environment in which we know that there are ongoing active attempts to sort of interfere with critical infrastructure in the United States. And then issues about confidentiality and multi-state licenser of providers. I think from the lab perspective, [00:12:30] again, we'll hear that providing specimens to a national program comes with a lot of other regulatory issues from the point of the providers and also the laboratories. Reimbursement issues are of great concern to the laboratory operators and to providers, how we deal with insurance, and how these tests [00:13:00] are considered.

	And then we also have provider reluctance in some settings and in flexibility of systems. And especially when we're thinking about, for example, needing to have ongoing testing to promote, or to enable the availability of refills, we have to think about how all those relevant tests results can get into the system so that at the point of the patient, if she's trying to refill her prep prescription, that all those results are properly accounted for in systems [00:13:30] that would allow her to then go forward with that sort of three month renewal. So those are some of the determinants. Then the middle part of this is really a grid that I think we can think through during the conduct of this meeting. But the idea here is that there are a number of health services that are listed in the column. Risk assessments, behavioral counseling, something physical like condom distribution, which seems more of a challenge through e-health. Health education.

	[00:14:00] HIV and STI screening versus diagnostic testing, treatment and pharmacy, test of cures, partner services, prep provision, viral load monitoring. And so for each of these, we can think about the mix of potential delivery mechanisms. And are there some things that at least on their face seem to require a face to face interaction? You know, for example, condom distribution used to be incidental. I worked as a volunteer HIV counselor and tester at Aid Atlanta [00:14:30] for a number of years. And this was sort of bundled up with the service of providing prevention counseling and screening was the availability and distribution of condoms. In other tele-health interventions that we've been working on with CDC, we've simply put condom ordering and shipping from Amazon into that service flow. But as you think about across these health services and about these ways of providing services, we may quickly say there are some things that we think are inherently better [00:15:00] suited to certain delivery mechanisms and some things that really may be possible across any of them.

	And I think by thinking about the location, the roles of the providers, the flexibility of time and place, that if we get that mix right, then we can get to the consequences. And in this case, a lot of positive consequences in terms of expanding reach and coverage of services, [00:15:30] accessibility, hopefully acceptability on the part of patients and providers, and the effectiveness of those services. There's a lot to be done about the cost and cost effectiveness of delivering these services remotely. For example, Jen Hecht will talk about test kit distribution programs. And we think about the cost of those, what are the metrics and what are the counterfactual programs that may be providing in-person counseling and testing through directly and indirectly funded CDOs. [00:16:00] Impacts on transmission dynamics by reaching people at critical points in networks with frequent opportunities for screening and treatment. And I'm so happy that we're going to have an explicit discussion about health equity and whether these tools are a way to promote health equity, or whether they are risks that we might actually worsen health equity, depending on our attention to equitable access.

	And then, [00:16:30] I think surveillance problems is one way to look at it. I think it's opportunities for surveillance to be more inclusive. And the idea here is if I do an HIV self test at home, and I have a positive result, that in and of itself will not directly make it into a traditional case surveillance system. And so for each of these tests, I think we want to be asking, what's the linkage to care, and at what points in the sort of confirmatory testing and linkage to care, [00:17:00] those surveillance needs are met. And I think for each of the kinds of services, we need to think that through. All right, so this is sort of the big picture framework. And then the second slide that I want to talk about has to do with implementation.

Slide description: 	Implementation Framework — Based on CFIR [Adapted from Pinto et al, Annals Palliative Health, October 2019] 

	Outer Setting includes: Funding, Regulatory environment, Mandates, Policy drivers, and Reliability of communications resources. The Inner Setting is surrounded by the outer setting and includes: IT infrastructure, IT expertise, Healthcare environment, Culture, and Supportive management. The inner setting surrounds the individuals which includes: knowledge and competence, attitudes toward remote testing, comfort with technologies, and perceptions of client willingness.

	The Intervention parts include: Relative advantages; Relative disadvantages; Appropriateness feasibility and validity in remote care; Complexity; Design, quality, packaging; and Cost.

	The green implementation arrow points from the intervention section back to the individual section. Implementation includes: Option leaders, Planning, and Champions.

Patrick Sullivan:	And so now, when we talk about implementation, there's a lot of aspects to this. But this slide is adapted from a sort of way of thinking about this that was in a palliative health journal, but it's based on the consolidated framework [00:17:30] for implementation research. And here we can take those notions about implementation research and put them on to program. And so I just want to briefly talk through some of these areas and remember that even for the intervention parts of this consideration, we're really thinking about the organizations that will implement these tools or implement these interventions. So that might be a state or local health department, [00:18:00] that might be a community-based organization, that might be a federally qualified health center. And so when we talk about these terms, think of them in that respect. And so from this perspective of the intervention itself, the interventions pluses and minuses to be considered in the context of who's going to be implementing it.

	So we think about relative advantages of the intervention itself, which might be around convenience or cost relative disadvantages, [00:18:30] and really the appropriateness and feasibility in the use in healthcare, in remote care, from the perspective of the organization that would be providing that service. And this might have to do with the design, the quality, the packaging, the clarity of the instructions. Aaron [Ziegler's 00:18:50] done work with thinking about video instructions that help facilitate the correct collection of specimens for STI testing or prep monitoring. [00:19:00] All of those are aspects of the intervention that are going to impact the success and implementing and certainly costs. Let's just say that a health department or community based intervention decides that they want to start a program of mailing out STI test kits, or there's a national program of distributing or quick kits for at-home testing. The next question is around how that implementation is handled within the organization.

	[00:19:30] So this green arrow speaks to the process of implementation. And it has to do with planning within the organization, who the organizational champions are. I think a great outcome of this meeting is that folks who are on this call who have reached and either run implementing organizations or have reached to them, could envision themselves as champions of some of these technologies in the right places. [00:20:00] And then opinion leaders may have to do with sort of either the external or the internal environment of the organization of who's going to help reflect the opportunity of these, point out the opportunities for health equity, and make that bridge into the organization itself. When we talk about individuals then in the CIFOR, we're really talking about individuals in the implementing organization. We've talked [00:20:30] separately about sort of patient side preferences and potential benefits, but within the organization, how knowledgeable and competent are the people who need to be implementing this about these types of interventions? How do they feel about remote testing?

	And if they feel like it's something they would never do themselves, and they can't imagine why someone would want to test themselves at home, that is going to impact how that implementation goes. There's a piece of education. Again, the opinion leaders and champions sort of can help shape that. [00:21:00] The level of comfort with technologies among the implementers and that may need to be addressed with training and their perception of client willingness. And I think we often hear this when we start having conversations of providers or staff who say like, well, the clients I see would never want to do that at home. The clients I see would never be comfortable working with their smartphone to get the results. And so that might [00:21:30] lead to need for some other kind of client assessments or thinking about what other components of an implementation package are needed to address concerns about the client's ability and willingness to engage.

	And then we move to the inner setting within the organization. And for remote health, we might need to think about things like information technology infrastructure and expertise, but also the culture of the organization. Is the culture of the organization [00:22:00] one that wants to be leaning into the latest things that CDC and other providers are offering? Is there a perception that their own clients are hungry for that sort of innovation? Is management supportive of changes that might require additional IT infrastructure or retraining of staff or different kinds of staff? And all these sit within the implementing [00:22:30] organization and are things that at least need to be considered before the decision to implement that is made, or if a decision is made to assess these things, to think how they may support or be impediments to implementation. And the last layer here is the external setting, just keeping in mind that the implementing organization, whether it's a CDC directly or indirectly funded CBO, a health department operates in certain contexts.

	And part of that may be [00:23:00] funding. New equipment or training is needed to implement these programs, but that's just not in the budget. The regulatory environment. And I'll just say, we have a regulatory panel, which is great, but I'll just say sometimes I think these are regulatory barriers. Sometimes I think these are perceived regulatory barriers. And so if there are questions we need to clarify what is possible, what is regulated, and if those need to be changed, that's another process. [00:23:30] Mandates for program that may come from state, that may come from CDC. The drivers of policy. And then just in the service area, what is the reliability of communications resources? If you are a CBO that's serving a primarily rural area and cell phone coverage outside the house or inside the house is an issue, that really may shape what is feasible to implement.

	So just to recap, the idea of this [00:24:00] framework is to think about the implementers. And the reason that it's useful, I think, to use these frameworks is that it's not enough to develop an intervention and say, it's ready to go. I live primarily in a researcher world now, and I think in some ways, historically, we viewed our role as, design it, test it in some kind of rigorous trial, and look at our P values and decide whether it's a good thing, and then the world will be changed. But I think for [00:24:30] many of the people on this call, and I think as our field, academic field moves more to bridging into that and that sort of implementation phase, I think the reason we need these frameworks is that there's so much heterogeneity in the implementers. And if we don't recognize that, then we'll never reach the potential.

	So I mentioned in rural areas, it may be about the availability of broadband internet or the speed [00:25:00] of cell signals to support two way video chats. In New York City, what we've learned is that the delivery of packages is quite complicated. And even though we have someone's mailing address, that may go to what's called a drop at a central point in an apartment building that has several hundred apartments, and it may be that the delivery of that package in this densely urban area has complications [00:25:30] that we wouldn't have in rural areas. Certainly the idea of privacy in rural areas comes into play. So the reasons that the implementation framework like CIFOR is important is because of this heterogeneity in implementation settings. And it's simply a way to think through systematically all the things that might be barriers or facilitators and the context in which implementation should happen.

	So in the two minutes that I have left, [00:26:00] I just want to say that what I've tried to do is to raise your antenna to a number of issues on the issues of determinants of the success of these programs, their possible consequences, and the principles of implementing them in different types of public health and service provision settings. And what I'm excited about as we wrap up this session is that we're just going to move directly [00:26:30] into a next phase, which is talking about some real implementation examples that I think will illustrate these principles. And a lot of the other pieces like the role of communication technologies, the laboratory pieces, the role of pharmacies and rural health, are all going to come out, on health equity are all going to come out in the session.

	So I want to thank Sevgi again [00:27:00] for her vision in calling this question and in pulling together the presentations that you're going to see. And I hope this has been helpful just to turn our thinking towards some of the questions we need to be asking as we listen to the presentations that will follow. And so with that, it's my pleasure to be able to introduce the first set of talks. And I love that we're going straight to examples of how [00:27:30] these tools are actually being used. And I'll introduce our first speaker, and then I'll ask each speaker to introduce the following one. So it's my pleasure to introduce Dr. Mary Ashmore, who will present on the New York City Hotline. Over to you, Dr. Ashmore.

Slide Description: 	Implementation Platform Examples

	Speakers: Mary Ashmore, MD, MPH — The NYC HotlineKaren Wendel, MD — The Denver InitiativeCharlotte Gaydos, DrPH, MPH, MS — I Want the KitJennifer Hecht, MPH — Building a Home Testing PlatformJune Gipson, PhD — My Brother’s Keeper / Open ArmsAaron Siegler, PhD — ePrEP for Adolescents and Young Adults

Mary Ashmore:	Okay. Thank you so much, Patrick. So I'm one of the medical directors at the Bureau of STI in the New York City Health Department. And [00:28:00] I oversee what we are calling our sexual health hotline. Next slide, Patricia, please. Thank you. So this is what one would see if they looked at our website. And by clicking on the link at the bottom of the slide there, a patient in the community could find our telephone number for our hotline. 

Slide Description: 	Screen shot of website on “Our Health” page with “Health Topics” selected and information about Sexually Transmitted Infections (STIs) as the main content. The link is titled NYC Sexual Health Clinic Hotline.

Mary Ashmore:	Next slide, please. [00:28:30] So pre pandemic, New York state public health law mandated that jurisdictions provide safety net for STD services. So New York City Health Department had eight fully functioning sexual health clinics.

	One in the Bronx, three in Manhattan, two in Queens and two in Brooklyn. They were all walk-in setups providing clinician business and screening only visits. There were no [00:29:00] appointments in truly an urgent care model. We were open five days a week for all eight sites. We had Saturday office hours at two sites and two evenings had office hours. Services were rendered irrespective of ability to pay. Everything was confidential. No documentation needed, obviously. And we provided care to patients age 12 and up with no parental notification. Next slide, please.

	[00:29:30] Thank you. So the services pre pandemic, I'll just mention them quickly. Routine exams for symptomatic patients in their context, screening visits for STIs and HIV, on-site STI treatment with dispensing medications, vaccines, mental health services onsite, partner services, pep prep, HIV treatment, [00:30:00] emergency contraception, and same day contraception start for long-term contraception. Next slide please. So this is what Times Square looked like pre pandemic. 

Slide Description:	Picture of people walking on crowded sidewalks and in a crosswalk in Times Square.

Mary Ashmore:	Next slide. Thank you. Everybody remembers these slides from early in the pandemic. 

Slide Description:	Chart showing How Coronavirus cases in NYC have soared. NYC Deaths: 280. From March 1 through March 25 numbers of cases increase until the final total on March 26th is 21,393.

Mary Ashmore:	Next slide, please. We were the epicenter of the pandemic, as we all know. [00:30:30] 

Slide Description:	U.S. map showing New York with the highest number of cases throughout the country. Map includes Puerto Rico.

Mary Ashmore:	Next slide, please. This is what it looked like after the lockdown in Times Square. Very eerie. 

Slide Description:	Photo of downtown NYC showing almost empty streets.

	Next slide, please. Next slide, please. I need to run through these quickly. I probably have too many of them. So after the lockdown from March to June of 2020, we had one clinic open for very limited services. [00:31:00] Closed seven clinics. 

Slide Description:	Clinic Access: Chelsea remained the only clinic open for services five days/week Walk-in basis (Both MD & screening-only visits) for very limited services.

Mary Ashmore:	Next slide, please. This is what our trends in monthly visit volume looked like. Went off the cliff. But you can see there in the little green line going up, that was our telemedicine hotline service, which began in March, the 31st of March. Next slide, please.

Slide Description:	Chart showing the overall number of visits dropped from more than 9,000 in February 2020 to almost zero in April 2020. Telemedicine rose to almost 1,000 in April 2020.

Mary Ashmore:	Next slide, please. [00:31:30] Okay. So some advantages that we had at the health department for a really quick turnaround, a telemedicine hotline startup, were the following. We had software already set up. We had a working relationship with a pharmacy that had been delivering limited amount of meds to our pre pandemic clinics. We had e-prescribing already in use. And we had staffing. Because we closed seven clinics, we had a lot of staff who were available [00:32:00] to work on our hotline. Next slide, please. The health department always had a call center that administered hotlines previously. So one of them is the provider access line, which is a way for community clinicians to call and report cases and also for them to request consultations for tuberculosis immunization [00:32:30] and Disease Control Bureau consults. Also, the call center had a hotline for vital records. They had a hotline for dog licenses. And now they had a hotline for us, the sexual health telemedicine hotline. Next slide, please.

	So the way the system worked is that we were given a unique telephone number, and once the patient called within [00:33:00] that phone system, software took over and routed the calls in a phone tree. And we ended up having three work groups that were created for us. Patient pressed one for STD results, two for STI or HIV screening questions, and three to speak to a clinician. Next slide, please. So about the pharmacy, we wanted to make sure [00:33:30] that from the hotline we could provide free delivery to our patients who needed medication, and also to make sure that if insurance didn't cover it, that the health department would cover that cost. Insurance submission was not required, especially for our very young patients. That's important.

	We created a system whereby all of our formulary medications that were available in the clinic previously were [00:34:00] available on our hotline to be delivered through this pharmacy. We did add oral cefixime and ella, which is a more forgiving emergency contraception when one considers the timeframe. And as I said before, e-prescribing was already in place. Next slide, please. So our structure of staffing. We have two physicians in charge who are directly [00:34:30] supervising the staff, scheduling staff, and creating role assignments. They update protocol communications which are constantly changing, and they do chart review in real time. We have six clinicians, including nurse practitioners and physicians, who conduct virtual telephone medical encounters and advise when a patient would necessarily need to [00:35:00] go to an onsite clinic as either appointment or a walk...

PART 1 OF 6 ENDS [00:35:04]

Mary Ashmore:	Go to an on-site clinic as either appointment or walk in. Of course they write prescriptions for the pharmacy to deliver.

	We have five triage nurses who mainly field questions about STIs and transfer appropriate calls to clinicians for those people who need a virtual appointment. Those triage nurses also registered patients in our electronic medical record.

	We have one administrative nurse who organizes appointment [00:35:30] schedules and communicates those appointments with the clinic staff and also follows up with our no-show patients. Next slide, please.

	I also wanted to mention that our scope of work on the hotline includes a social work team that conducts behavioral health telemedicine visit appointments. It's very important to note that for any patients who are in the clinic who need [00:36:00] an acute mental health assessment, we can then refer to the social worker who is assigned to the hotline for the week and they can conduct a virtual visit for those patients. Next slide, please.

	Our scope of work is to provide syndromic treatment for urgent STI complaints, medications to be delivered for anybody who is presenting to the hotline with a positive STI test, [00:36:30] either done in one of our clinics or elsewhere, providing emergency contraception. I do have to emphasize this. This is not an appointment-based telehealth model. It's an urgent care-based model.

	Also to mention that the hotline's purpose is to triage referrals to the clinic and engage in bi-directional communications with patients without a clinic visit. [00:37:00] We never had the opportunity to do that before because a telephone number was never available to our patients, unfortunately.

	Also, to do some pre-screening and counseling in order to reduce the cycle time for those patients who do need to present to the clinic, and that was very important to reduce the risk for COVID transmission. Some of the examples of potential diagnoses that needed to be seen in a clinic were suspected PID, pregnant [00:37:30] syphilis or patients, or those who could become pregnant, those in need of penicillin or cephalosporins and were allergic to them, suspected epididymitis, contact to HIV so that one could provide PEP in the clinic, acute viral syndrome, maybe possible HIV or HIV, and any positive HIV tests. Next slide, please.

	[00:38:00] Soon after the CDC released their guidance, the Health Department in New York also released a dear colleague letter. Next slide, please.

	That's an example of the CDC guidance. Next slide, please.

	Or a screenshot, I should say. So the medical directors and some of our displaced senior STI physicians put together our own telemedicine protocol [00:38:30] in approximately a week's time. This is a screenshot from that. Next slide, please.

	Then using both CDC guidance and our telemedicine protocol, the Bureau of STI created a 12 page guidance table for the community providers to allow them to use some of the same principles we were using for treatment of STIs, syndromic treatment. Thank you.

	[00:39:00] By May 11th, we were able to open a second clinic in Brooklyn. Next slide, please. Thank you.

	I do want to mention that we have had some opportunities to evaluate our new hotline platform. Time issues for me today will not allow me to go into too much detail, but I have included them in the slide [00:39:30] set in case anybody's interested in looking at those results. 

Slide Description:	Evaluation:

· Initial: hotline serves many MSM, persons of color, & foreign-born patients

· Patient appointment satisfaction survey

· Spring 2021: survey among SHC hotline team

· Demographic difference study between new and established patients calling the hotline for the first time

Mary Ashmore:	Next slide, please. Next slide. Next slide. Next slide. Next slide. Next slide, please. Next slide, please. Next slide, please.

	[00:40:00] Okay. So as time evolved, we added new services. So we added EPG for gonorrhea and trich. We added home HIV testing, PEP referrals to the clinic, HIV treatment appointments, pre-counseling for tele-PREP, we call it, a new EC medication, and then also pre-counseling for telecontraception and partner services. Next slide, please. Next slide. [00:40:30] Next slide. Next slide. Next slide.

	So by the end of July, we were able to open up a clinic in Queens. Next slide.

	I just wanted to make a point about our social work team on our telehealth hotline, telemedicine hotline. So we average about 100 social work [00:41:00] registered visits per month during the timeframe of April through the end of November. Next slide, please.

Slide Description:	Behavioral Health Telemedicine Assessments

	Benefits:

· A quick referral pathway between clinician and social worker for risk and other bh assessment

· Easy access for patients to connect with social worker by phone

· Social workers have been able to provide harm reduction services by phone and mail naloxone to patient when indicated

	Challenges:

· Some patient prefer in-person or video conferencing to phone sessions

· No response to outreach efforts

· Technical issues sometimes delays outreach

· Social workers have in-person clinic tasks which can delay a session

Mary Ashmore:	This was a slide that was given to me by the Director of Behavioral Health, and I just wanted to address it. Benefits for our social workers is a quick referral pathway, easy access via phone, and [00:41:30] social workers, in fact, have been able to provide harm reduction services by phone and to actually mail Naloxone to patients when indicated. Some challenges had to do with technology and [inaudible 00:41:59]. [00:42:00] Next slide, please.

	Okay, thank you. By middle of November, we had a clinic open in the Bronx. Next slide, please. Next please. Next please. Next please. [00:42:30] Next please. Next please. Next please. Next please. Next please. Next one, please.

	Okay. Over the course of 13 months, we had 33,000 calls fielded on our hotline. Next slide, please.

	And [00:43:00] we had more than 8,000 virtual visits. As you can see, the number of those visits reduced as more clinics were opened up. Next slide, please. Next please.

	As you can see now, we have uptick in visits in our brick and mortar clinics, but we still have quite a number of telehealth, telemedicine hotline visits. Next slide, please.

	[00:43:30] Okay. Our continuing challenges are pharmacy issues, some deliveries were delayed, software, hardware, not everyone was able to have a laptop who wanted to work on telehealth, and the social workers wanted to be able to see patients. We need a reminder system, a platform, and a scheduling system platform, and other things such as changing [00:44:00] our scope of services with new protocols was a challenge. Next slide, please.

	Okay. I think I've run out of time, and I can move on to the next person. Next slide, please.

	This is just what our web page looks like now with all of our services listed. Thank you. Thanks everyone. [00:44:30] Next slide. Next slide.

	I think I need to now introduce Karen Wendel. Next slide.

Karen Wendel:	[00:45:00] All right, I'm going to go ahead and share my screen. I'll just ask someone to confirm that they can see that. So my name is-

Speaker 1:	Yeah.

Karen Wendel:	Thank you. My name is Karen Wendel. I'm the director of HIV and STI prevention at Denver Public Health, and I want to thank the organizers for allowing me to come and talk about the Denver initiative and our experience here with designing a platform that we just implemented this [00:45:30] month, so we're very excited about that and I'm here to tell you a bit more. These are my conflicts of interest.

Slide Description:	Conflicts of Interest

	Hologic grant fundingPfizer stock ownership

Karen Wendel:	In Denver, when we're providing sexual health services, it's a three-pronged approach. We have an outreach team that does targeted testing, venue-based or mobile providing triple site GCCT testing, point of care HIV and syphilis and hepatitis C testing and lab based HIV and syphilis, and then counseling and referral for PREP, PEP and other services. Our sexual health clinic, which [00:46:00] provides STI testing and care, family planning, PREP and PEP, and rapid start HRT. And our community testing program that really only provides urine and gonorrhea, chlamydia testing for men and women.

	At CBO's schools, local health departments businesses, and this has been in effect for many years, and really over the last two years, we've been thinking about how to provide services directly to clients and to try to expand our [00:46:30] reach into clients and provide them with services that might deal with issues that affect access such as stigma, transportation, and work hours.

	Looking at developing an online home testing service. But then came COVID and we lost for a year our community and outreach testing programs, but we gained telehealth PREP services and the ability to do evaluation for STIs via telehealth with mailed treatments [00:47:00] by FedEx, and really came to recognize that an online home testing platform could be integrated into that remote type of sexual health service.

	In looking at designing our platform, we had several goals. We wanted to expand access to non-clinical STI and HIV testing and reach deeper into the Metro, into sites that were further away from our clinic and where our outreach team doesn't go, and really think about even serving communities and counties outside the Denver Metro area, such as Southern [00:47:30] Colorado, where we know there are folks who are disproportionately affected by STIs and HIV. In addition, we wanted to educate everyone that visited the site about STIs and HIV testing, treatment, and prevention, and about contraceptive services and the client's options in that regard, and then provide a way on the site to figure out where you could access the services that you needed at a most convenient location. Finally, as we learned our lessons from COVID, we [00:48:00] decided that this portal could be integrated into our sexual health clinic, telehealth services, and our ability to mail medications to clients.

	When developing our platform, we reached out to two key folks, that was Charlotte Gaydos, who I'll have the pleasure of introducing next, who is really a founding leader in developing these online services, and got a lot of guidance from I Want the Kit folks, and then reached out to California colleagues about their I Know [00:48:30] program. This was the second U.S. public health STD home testing program, and provides free gonorrhea and chlamydia home collection for women 12 to 24 years in age using a vaginal swab Aptima, and focusing services for African-American and Latino women.

	The program launched first in Los Angeles in 2009, and then in Alameda, San Diego, and Sacramento with the support of the California Department of Public Health in 2013. In 2021, they plan to expand [00:49:00] to eight new California jurisdictions. We really have developed a partnership with our colleagues in California and use that developer to develop our platform, and we're able to create a new wire frame that then our California folks were able to use to update their site for a mobile friendly platform.

	The I Know program has extensive experience that we were able to leverage when creating our platform. They've sent out over 11,800 kits. About 50% of clients have completed those [00:49:30] kits and send them back in, and in those four California counties, their positivity rate for chlamydia is 8.2%, gonorrhea 1.15. Any positive test was found in 8.9%. In L.A. they're able to confirm treatment in their online and phone-based orders, and 84% of their clients and 3,000 kits were distributed through their tablet outreach in L.A., with a 9.2% positivity for chlamydia, and 1.9% for gonorrhea. For that program, able [00:50:00] to confirm 63% of treatments.

	This is a view of our platform that we launched this month. We updated the wire frame from the California version. When you click into this, you get our order entry system. Testing and Instructions allows you to view instructions that are detailed for every different specimen type. Care Near You allows you to add your address and have it navigate you to clinical sites that are near you that can provide services and then to click in [00:50:30] and really learn more specifics about what's available and the cost. Then The Facts is really there to provide information on gonorrhea, chlamydia, syphilis, HIV, PREP, PEP, and also birth control, and allows for brief interactions and brief distribution of education while linking to more complex sites such as the CDC for more information.

	In thinking about our program, we wanted to expand from the California model to include triple site testing for gonorrhea and chlamydia [00:51:00] for both men and women, and use OraSure HIV self testing for the HIV testing component of the testing system. Like the California system, we wanted clients to be able to enter orders, outreach team to be able to enter orders, and for a sexual health clinic to be able to enter a phone order for a client.

	But we also created a new path in which, on the administrative side, we can add a clinic and they can have limited access to only their patients where [00:51:30] they can enter orders and see the results of home testing in their clients. We really envisioned this as something that we would roll out to other sexual health clinics or Title X clinics. I'm going to just back that up. Really what we're thinking here is that a Title X clinic who is taking care of clients, putting in LARCs, and really wants to keep up that yearly screening in their patients who are less than 25 that are women, they could enter an order into the system.

	[00:52:00] They would first verify with the client that they're okay with getting a package in the mail, they feel comfortable collecting their own, and want that added convenience of not having to come into the clinic. Then they would enter the client into the system. The client would get either a text or an email message as they choose. They would ask them to complete the consent form, and then the kit would be mailed to them. That partner clinic would then have access to only the results of the patients that are affiliated with their clinic.

	So [00:52:30] in thinking about our program, one of our greatest concerns was cost and sustainability. We have not been able to incorporate billing of insurance. That is a bigger step than we have been able to think through how to really support that. But we've enabled several different methods to try to control the cost of the program and be able to sustain it even when there are periods where grant funding may not be available. In [00:53:00] order to do that, what we've done is put into place on the administrative side of this portal the ability to control when testing is free and when a client has to pay a low-cost fee.

	Those controls include the test that is billed, tests that are not billed, frequency of testing, so currently the way it's set is anyone in Colorado can get one test for free. They can test up to every three months, but for the three month tests, they will have to pay the low cost fee. That is [00:53:30] really a break even fee for our program. And we can turn on and off free testing based on county in Colorado, so that we can partner with different local health departments that may have grant funding that allows them to support free testing in their jurisdiction, and can really reach into those communities and help other areas in Colorado, not just clinics, but local health departments serve their community.

	The cost of the test is completely adjustable. As I said, the tests that are charged is adjustable. Then we [00:54:00] have, as I said, this ability to add by contract other clinics that could pay for access for their clients. Then we've really focused on trying to limit the amount of work on the backend that goes into this for our staff, and we'll be utilizing the sexual health clinic staff to really man the portal.

	What you can see here on the right is an order form. The client gets to this page, they see what's on their menu. Here this client meets criteria [00:54:30] for urine, throat, and rectal testing, and a home HIV kit. They can de-select a test that they don't feel comfortable testing. If there's somebody who has a very strong gag reflex, they may say, "No, I don't really want that pharyngeal test." And they can see the cost of the test, so if the cost is too high, so if we're in a paid jurisdiction, or if they're wanting testing more frequently than we're currently providing for free, they can see the cost of the test and the total, they can de-select, it will update, and then they're taken [00:55:00] to a payment page where they can put in their credit card, or you can bank information through a program called Stripe.

	The thing that we see here is our testing instructions, and they can click into any of the options, urine throat, rectal, or HIV testing, and then the mailing instructions are on the site. What we found to be the biggest barrier during this process was the validation of our labs. So initially we had constructed this site to partner [00:55:30] with our own Denver Health Lab, but after significant thought and discussion with folks at the CDC and with our other partners, really came to identify that the cost and time that was going to be required to validate each of the three samples was going to be prohibitive and delay us quite a long time. SO we diverted and have partnered with commercial lab MTL, and our site directly communicates through an API with that lab [00:56:00] and gets results back that then are provided to the client.

	So our developer was able to work out that connection, and we really think this is going to benefit us in a couple of ways. One is the cost and time, as I mentioned, for validating our own lab. The other is that there are always new tests that could be offered. So currently our site does not offer syphilis home testing, but if we wanted to do that in the future, this is a bigger lab that we're partnering with that has already done a lot of these validations. It diverts [00:56:30] from each lab having to validate all these different tests and being able to bring online a different test, like a creatanine or a viral load, without the burden of our own lab having to validate that system. In addition, it takes away some of the staff time required for holding up a platform like this, because they provide us with the kitting while inserting the handouts that are specific to our program into the kit.

	So our information [00:57:00] about the clinic, about accessing telehealth services, and about linkage to care, if an OraSure should be positive when a client does it at home, are all available within the kit. After a client receives results, if they come through the lab portion, they get a notification by the route that they specified, either through text or through email, and then they get regular reminders if they fail to look at their dashboard and view their results. Then on the backend, if a client [00:57:30] fails to look at their results over a week, we have the ability to reach out to them with their phone number or their particular means of access that they described as their preference, and really interact with the client in a more personal way, taking it offline, trying to make sure that they're aware of their results, and if they've been unable to navigate into care, assisting them in doing that.

	On that administrative side of our platform, we have the ability to log those interactions. They're time-stamped and they're unalterable, and are retained [00:58:00] within the client record. In addition, on that dashboard, when they see their results, they immediately see information about how to access telehealth services in our clinic, which currently include chlamydia treatment, PREP, and some oral birth control options that can be accessed through telehealth. You can see here how we're able to enter an address and update the map. It'll take us into that location. You can click on a dot and get a little bit more information about the clinic nearest you.

	[00:58:30] So what we've run into as the major obstacles or barriers to online platform development are certainly cost and that issue of sustainability. Currently our program in doing that is to use grants, patient payments, and alter the free testing criteria to optimize access. Then looking at partnerships with local health departments and clinics that might be able to use grant money or jurisdictional [00:59:00] money to support free testing in their location.

	Test validation was a huge hurdle for us that we overcame through collaboration with commercial lab partnership. Then IT process and security, as Patrick has alluded to, this was a huge step for us that required across-the-board collaboration with our institution IT division, very extensive evaluation, user testing of the platform, followed by a commercial entity security [00:59:30] service screening of the platform for its ability to avoid penetration and uphold security. We also use AWS as our hosting platform, as a HIPAA compliant hosting platform. New challenges for us include marketing and use, and really how to optimize those, and how to optimize test completion and cost effectiveness.

	Finally, to an eye to health equity, how do we identify, incorporate, and adapt community needs? [01:00:00] We're really looking forward to developing some focus groups to really look at the site and to optimize it moving forward. We'll be rolling out the Spanish version of the site within the next quarter and have the ability to really upload all the language and instructions in Spanish to serve our latinx community. What population will we help? Who will be left out, and how do we prevent that? Certainly there all the issues with packaging and [01:00:30] delivery of these packages to adolescents or to other folks who have partners at home that may intercept the package. Those are things to be considered, and whether ability to pick these up at a centralized site would be of use. So really looking forward to getting community input to really optimize the equity of this mobile testing platform. Then finally, how can we improve accessibility access and completion to make this a more cost-effective approach?

Slide Description:	Acknowledgements

	Denver Health Team: 

· Alondra Landa

· Marinka Balancier

· Andrew Hickock

· Nancy Holtzmaster

· David Kimble

· Richard Kniskern

· MaShawn Moore

· Laura Weinberg

· Andrew Yale

	Collaborators:

· Debra Callabresi

· Freedom Scott

· Brad Thorson

	Support and Guidance

· Charlotte Gaydos

· Chris Hall

· Laura Kovaleski

· Harlan Rotblatt

Karen Wendel:	With that, I want [01:01:00] to just thank many of my collaborators and coworkers who helped put this platform up and get us up and running. Then I have the distinct pleasure to introduce Charlotte Gaydos, who is really a pioneering leader in home testing, and will be talking to us about I Want the Kit. So let me get out of your way, Charlotte. Thank you.

Slide Description:	I Want The Kit (IWTK): An Approach to At-Home Collection for Diagnosis of STIs

	Charlotte A. Gaydos, MS, MPH, DrPHProfessorDivision of Infectious DiseasesJohns Hopkins University

www.iwantthekit.org

http://hopkinsmedicine.org/medicine/std

Charlotte Gaydos:	[01:01:30] Today I'm going to introduce you to a program called I Want the Kit, which is an approach to on-home collection for diagnosis of STIs. I'd like to thank the organizers for inviting me to speak today.

Slide Description:	Disclosures: I have received funding for research grants and/or have been a lecturer for Becton Dickinson, Hologic, Abbott, Quidel, Binx, and Cepheid

Charlotte Gaydos:	These are my disclosures. Originally, I Want the Kit started as an academic research program for chlamydia and for women. It's now an academic public sector collaboration, which offers internet requests and in-home sample collection kits for [01:02:00] STIs, and also for HIV for self testing at home. We offer men and women the ability to be tested for chlamydia, gonorrhea, and trichomoniasis and HIV. The STIs include swabs from urogenital, such as vaginal and penile [inaudible 01:02:18], and rectal, throat, and oral fluid.

	By way of outline, we'll talk a little bit about the history and I'll introduce you to the upgraded website. But talk a little bit about pre- and post-COVID and what happened, [01:02:30] and then go into the home testing for point of care, and also how we can evaluate this type of program and the things that can be done, end with lessons learned and what is the future.

	In 2004, you could order a kit online, we mailed the sample home, and the sample was collected, and the results were all called to the person who participated, and they were told to ask what clinic they should go to for [01:03:00] treatment. In 2013, we made it more HIPAA compliant, and the person had to pick their clinic before they ordered the test, and also to take a risk quiz. They were been required to get their own results online. In 2021, we upgraded the website significantly with some great innovations and new clinical users.

	So, let's take a little website tour [01:03:30] of I Want the Kit. We added more than 20 new educational fact sheets and links to services and increased the number of services that we could offer about what happens if you were just diagnosed, HIV 101, the way that you should wear a female or a male condom.

	The ordering process is very simple. There are different screens. So the first step [01:04:00] is to make sure you're age 14 and older, and whether or not you fit the location for being in Maryland and Baltimore, or perhaps one of our Alaska users. The person registers with a HIPAA compliant website, and then they place their order, and they decide whether they want a vaginal test or a penile swab, or throat, or rectal, or all three.

	We've also had some web enhancements. It used to be that we had to manually results from our platform into the website. [01:04:30] Now, it just does it automatically, and so we don't have to enter all of the results by hand. For future we're going to do some modifications for some of our research clinics. We'll have a Spanish version, we'll have a better instructions, some additional reports, and also some auto messaging reminding people that if they ordered a kit to return it, and if they're positive that they need to retest after three months.

	Some old data that we looked at between 2016, I wanted [01:05:00] to show that we changed from about having any STI, which is shown on the top dotted line of about 12% down to about 8.3%. So you can see at the bottom the chlamydia, gonorrhea, and trichomoniasis, they bounced around from year to year.

	Then COVID came. Back up a little bit to summer of 2019 and we were able to obtain some funding in the HIV epidemic from Baltimore to be able to offer [01:05:30] just to the people in Baltimore, by zip code, the free HIV oral fluid test. We provided linkage for enrollment into PREP programs at this time. Then we were shut down. Then we reopened. We changed from about 30 people asking for kits in 2020, before 2020, to then in May and June, to about 160 a month, which is a five-fold increase. [01:06:00] Our positivity increase and our HIV test kits increased by 400%.

Slide Description:	Update of IWTK STD Home-Collection/HIV Home Testing During CoVID

	IWTK internet program as a replacement for in-person visits to BCHD STD clinics during the pandemic. Timeline shows first case of COVID in December 2019, HIV kits w/EHE available January 2020, IWTK shutdown on March 16, 2020, Stay at home orders BCHD clinics closure on March 30, 2020, IWTK restarted BCHD STD clinics, Telemed, Referral to IWTK from April 6 2020 to today.

Charlotte Gaydos:	This can be shown graphically if you look at the timeline at the bottom of this slide. Because the Baltimore city STD clinics were closed during the pandemic, you can see that when we reopened in April, the Baltimore patient clinics told them to connect for treatment and consultation by telemedicine, and [01:06:30] then for testing, they were referred to order a kit to I Want the Kit.

Slide Description:	IWTK STD Orders Pre- and Post-CoVID

	Pre-COVID 134 orders per month

	Post COVID 450 order per month; majority from Baltimore City.

Charlotte Gaydos:	So you can see here about the orders from this is the number of people. Pre-COVID was not even 150. Then after COVID all the way through December, the numbers of tests that were ordered for STIs were significantly increased.

	You can see also [01:07:00] the numbers of tests increased significantly. Because you could have one, two, or three tests per person. So, before we were doing 175 tests per month with a fairly low but nice positivity rate, to going up to 600 tests a month. Staffing was a great, great problem during this time, and our positivity increased. This [inaudible 01:07:27] the HIV home testing kits, you can see a huge [01:07:30] increase.

	So if you see, we started out slow in January and February, and then we were getting the requesters then from Baltimore, that in 2020, we sent out about almost 1,400 kits. The nice thing that we were gratified was that the number of participants who requested an STI kit also ordered a home testing kit, so this was great.

Slide Description:	2016 HIV Home Test Study

	OraQuick HIV Self-testing Study — results from questionnaire (n=200)

	Easy to collect oral fluid:  95.5%

	Easy to follow instructions:  91.5%

	Easy to read and interpret results:  96.5%

	Easy to perform test:  97.0%

	Believe result is definitely correct:  82.0%

		Or probably correct:  18.0%

	Trust result very much: 80.5%

		Or trust somewhat: 19.5%

	Definitely recommend to a friend:  94.5%

	Definitely test self again at home:  83.5%

		Or probably test self again at home:  14.5%

	Maximum price pay to purchase OTC: $10-24%, $20-42.5%, $30-14.0%, $40-16.0%

Charlotte Gaydos:	We don't have the data yet from our survey, which is still being analyzed, but I'll show you a snapshot [01:08:00] of an original pilot study that we did back in 2015, 16 of about 200 people where we sent them free home tests for HIV to do. You can see from these percentages, they felt that it was easy to collect the fluid, do the instructions, do the tests, perform the test. They believe their results were correct. They trusted their results. They recommend it to a friend, and they would test themselves again at home. So this was good [01:08:30] information for us. Interesting, even though our kits were free, we asked how much they would wanted to pay. Those people only wanted to pay $10 or $20, and we know that the price in our retail pharmacies is about double this.

	What happened to gender identity during COVID? You can see pre-COVID we had more females than males ordering tests. Then in the beginning of our analysis, we saw that we had more males than females. We do have some [01:09:00] other genders that request kits, especially since COVID began. Now lately, end of 2020, the numbers of males and females has about evened out.

	What happened to race? Pre-COVID, most of our [inaudible 01:09:19] from the state of Maryland in Baltimore were white, and you can see after we reopened in April that we had a significant increase in the racial [01:09:30] identity as black.

	What happened in 2021? You can see that in December and January, we had a lot of trouble with the post office, and I'm sure many people did, with their Christmas gifts being delayed, but the February through April and now May, we're starting to pick up requests again, and the same thing happened for the OraQuick orders for HIV. They went down in January and February, but now they're picking back up again.

	One of the questions [01:10:00] on our survey was we were interested in-

Charlotte Gaydos:	Questions on our survey was, we were interested in knowing about whether or not people would prick their fingers to get either a serum test or to actually collect a dried blood spot. And so when we did look at this data of for, 500 people who answered the questionnaire about 76% said yes, that they would consider pricking their finger, if they could get a syphilis test. So what happened to the [01:10:30] samples by way of the source of a swab can see that we had a huge increase. This data is from April to December of 2020, that the number of males that ordered rectal kits, and these are combined chlamydia gonorrhea results, both, but you can see that the total prevalence was 13.7% of having either one or both of these infections. Most were gonorrhea. You can see that not very many pharyngeal tests were done.

	And this is because [01:11:00] of swab supply problems. We had to stop taking throat test swabs two different times because of the shortage of swabs. And as we know, everyone had swab problems and supply problems during this past year. So what else can you do with online outreach programs? You can look an extra genital sample separately, do acceptability surveys. You can analyze the data and do surveillance in real time. And now we can do [01:11:30] it all automatically. You can look at risk assessment, geo-mapping and reinfection. So we published a couple of articles on looking at the anatomic site infections from data and about 3000 people from 13 to 16. And you can see that actually, we had a higher prevalence in males and females, if you look at the total 9.5% for rectal positivity compared to the prevalence of your genital [01:12:00] samples. We also publish the survey during this time period of about 500 people where we asked them, where did you learn health care as part of an acceptability.

	And here again, we asked them if they were willing to collect a dried blood spot for syphilis or HIV testing by pricking their finger. And you can see in the gray part of the pie that most of them said, yes, we were gratified by this data. Let's talk about risk quiz now. We actually [01:12:30] looked at having a voluntary risk score on our website where people could answer six easy questions by going click, click, click, click, click, click, and the program would actually give them a score of their risk. So when we did this with about 1500 people, the risk score, which could be from zero to 10 independently predicted an STI for women, but not for men. It was in the right [01:13:00] direction, but it didn't reach statistical significance. And then we thought this was all voluntary, more females than males provided scores.

	And only about 43, 44% actually answered the quiz. So we were curious about why the men were not answering and why the difference statistically. So this is the quiz. You can see that for questions one through four, you get [01:13:30] one point, questions five and six, it's weighted, depending on how you answer, how often you use condoms or whether or not you have sex partners. And interestingly, the website does not report individual questions because this is against HIPAA. And what it does is just give a score from zero to 10 and it does it automatically. And the person can see what their score is. So we continue to follow men, [01:14:00] almost 600 men looking to see if now it's required. It's not voluntary anymore. So everyone has to answer the quiz.

Slide Description:	Prevalence of STI among IWTK Male Users by Risk Score Category

	Risk Score Required (N=592) 

	Risk Score of 0-3 shows Prevalence of 6.2%

	Risk Score of 4-6 shows Prevalence of 10.9%

	Risk Score of 7-10 shows Prevalence of 14.3%

	Overall STI prevalence 10.5%

Charlotte Gaydos:	An overall prevalence for these men was 10% and you can see the prevalence actually tracked up with the higher the score. We divided it into categories. It was zero to three, four to six and seven to 10. And this is one trend was statistically significant. So a high score does predict [01:14:30] positivity in men when the risk quiz is required. So this was originally done to try to encourage people ordering kit [inaudible 01:14:44] score, and indeed same to hold very well over the years. Interesting for these men, we also did some geo-mapping of scores that were greater than seven on the left. So this is a map of Baltimore and that [01:15:00] you can see that in the red is six to nine people had scores, very high and the yellow show scores of zero. And then on the right-hand side, you can see this track pretty well with the zip codes of where we found the actual STIs from this analysis.

	So what are the lessons learned, which can guide future programs for others who want to implement these programs? You have to think about the area you're going to serve. Is it your state [01:15:30] or your city? Who are you going to serve? What your read portals [inaudible 01:15:35] best methodologies, and how to get the result back to the people or to the clinician who will perform the tests. And there's lots of logistical issues as way of saying over the last year, that related to COVID with staffing and supply shortages and of course the cost. So it is a risk of thinking outside the box. Could these online programs work in every [01:16:00] state? Yes, they could. They worked during the infertility prevention program. Every state provided free testing for STD clinics and family planning clinics for committing gonorrhea. So they could work.

	The future, we are going to continue to validate the use of dried blood spots and maybe even a way to collect actual blood that we could spend tubes down.

	We've done some validation for the fourth generation point of care tests and from viral load. So [01:16:30] stay tuned. I like to end with a summary statement saying that we see STIs were commonly detected by internet recruitment and home collection. High risk scores did predict STIs in men and women. We did a home point of care tests for trichomonas. And I didn't have time to talk about that today, but it was all good women liked doing the test. They got the right answer. And of course the ongoing HIV test is ongoing. [01:17:00] So our future plans besides HIV and syphilis, is that we're thinking about whether or not to offer mycoplasma genitalium and could home testing be used for prep patients who are required to test themselves for HIV and STIs four times a year, rather than take the time off and come to a clinic. We are doing that with a couple of our research projects.

	So we're moving from home collection, just for STIs to hopefully in the future, being able to do dry blood spots for [01:17:30] HIV and syphilis and PrEP patients routinely, instead of just doing it for research as we're doing now. So I'd like to thank all of my collaborators and our hard workers who really responsible for the collection of all this data. So thank you very much for your attention.

Slide Description:	Acknowledgements

· Johan Melendex

· Yuka Manabe

· Justin Hardick

· Jeff Holden

· Barbara Silver

· Tong Yu

· Rachel Fink

· Gretchen Armington

· Yu-Hsaing Hsieh

· Anne Rompalo

· Tom Quinn

Screen sharing is swapping to next speaker and there is a lot of silence while slides are being shared.

Jennifer Hecht:	[01:18:30] Good morning. Patricia, can you hear me?

Patricia:	We can hear you.

Jennifer Hecht	Okay [inaudible 01:18:58] excellent. Just checking [01:19:00] that everything's ready with the slides and I'll get going. Patricia [01:19:30] I was looking great. If you just want to get to the presentation view, I think we'll be all set. Can you bring me back up? [01:20:00] All right. I'm going to take a second and pull up an extra set of slides just to-

Patricia:	Give me a minute.

Jennifer Hecht:	Okay. Let me know if you have any trouble, let me know and I'll pull up an extra set.

Patricia:	Okay. I don't know what happened.

Slides are being showing to scan through to the correct presentation. There is silence during this time.

Slide Description:	TakeMeHome

	Building a Home Testing Platform

	Jen Hecht, MPH

	BHOC 

NASTAD 

Emory 

Rollins School of Public Health

Jennifer Hecht: 	Yeah. It's all right. I saw it there. They're there. There [01:20:30] we go. Perfect. Thank you so much. All right, good morning and good afternoon, everyone. Thank you so much for the opportunity to participate in this webinar. [01:21:00] My name is Jen Hecht and I'm the co-founder and director of Building Healthy Online Communities. I'm so happy to have this opportunity today to share this home testing project that's been developed by BHOC in partnership with NASTAD and Emory, and which launched in March of 2020. Next slide, please.

	First, I'd like to take a small bit of just a moment to share a little bit of background about Building Healthy Online Communities. BHOC [01:21:30] is a consortium of public health organizations and health departments working in partnership with dating apps to improve sexual health among dating app users. We have three primary goals. First and foremost is to advocate for changes in the environment or features of the apps to achieve permanent solutions that promote health and reduce stigma. These, for example, could include personal profile that help users make informed choices about their sexual health strategies, like being able to put PrEP, using [01:22:00] condoms or having undetectable viral load in your profile. We also coordinate with public health partners to improve messaging on the apps and identify best practices for the most cost-effective ads. And finally, we coordinate interactions with the dating sites and apps so that we in public health, aren't all going to the same owners with dozens of different requests. Next slide, please.

Slide Description:	Public Health Partners

	CDC Center for Disease and Control and Prevention, NASTAD National Alliance of State & Territorial AIDS Directories, National Coalition of STD Directors, National Coalition for Sexual Health, AIDS United, San Francisco AIDS Foundation, yth Youth Tech Health, University of Washington, Johns Hopkins University, Yale, Emory University

Jennifer Hecht:	We work with a number of governmental and non-governmental partners, as well as researchers. [01:22:30] And we rely on them for expert advice as well as data formative research and prioritizing interventions. User input is an essential part of our process, and we continue to gather data from app users on a regular basis in partnership with our colleagues. Next slide please. 

Slide Description:	Website and App Partners

	Tinder, DaddyHunt Real Men – No Attitude, dudesnude, Adam4Adam, Gay.com, Grindr, Hornet Gay Social Network, POZ Personals, Bareback Real Time Sex BarebackRT.com, Growlr, Scruff, JACK’D

Jennifer Hecht:	We prioritize working with apps that represent those with the largest number of users in the U.S for the most efficiency. Some of these sites attract a wide [01:23:00] variety of men, such as Grindr, Tinder, Adam4Adam, Scruff and Jack'd, and others have more specialized niches, such as GROWLr, Daddyhunt and POZ Personal. Next slide please.

	So how did we come to focus on home testing? In our partnership with Emory during a recent survey of 10,000 MSM, we found that 75% of MSM had used a dating app in the past year to meet a partner. And 22% of MSM [01:23:30] on those apps had never tested for HIV. So given the large number of sexually active app users who hadn't ever tested or hadn't tested recently, we identified this as a huge opportunity to increase testing among this group. We also did formative research about different dating app based interventions and found strong support 77% for home testing among app users. Next slide please.

	[01:24:00] So our solution was to build a home testing platform that would be promoted through our partnerships with the apps. TakeMeHome is a national platform for ordering home test kits that helps public health departments ensure testing access for folks who might hesitate to walk into a clinic. Tests are available to community members for free and participating health jurisdictions @takemehome.org. We've leveraged our excellent partnership with NASTAD for this project to help us coordinate with state and local health departments who want to participate. [01:24:30] Health departments need only sign up through BHOC and then set up payment through NASTAD. And health departments do not need to take care of any of the logistics of packing, shipping, ordering kits, or hiring staff. And our partnership with Grindr and several other apps enables us to promote directly to consumers. Next slide please. Here you can see what the site looks like on a phone, which is how most users get to it.

	The design is [01:25:00] intended to be engaging, discreet and simple to reach our target audience who shared in user interviews, that they prioritize discreet, free and nonjudgmental services. And the experience for the participant is that they see a message typically on a dating site, which links them to our platform. There are four simple questions that users must complete before entering their name and mailing address to order a kit. Users can order an HIV oral rapid test in about one minute and a lab based test [01:25:30] in three to four minutes. Users will receive in the case of the HIV oral kit, they'll receive an OralQuick kit, which has an extra insert with instructions and also some condoms. Next slide, please.

	So currently in areas offering the HIV oral test kits, users need to be 18 or older. However, in locations offering lab based testing, this is flexible based on local laws. And while we did start off focusing on users who hadn't tested in at least a year, [01:26:00] we've since created the opportunity for each site to tailor their eligibility criteria for their constituents. Our services are not just for MSM though, because of our relationships with the gay dating apps, MSM do make up most of our users. For individuals who test preliminary positive and the HIV oral rapid test at home, they get three sets of resources. The first is from OraSure, which offers a 24/7 hotline. The second is the CDC widget, which enables a user to enter their zip code, [01:26:30] to find a test site near them for confirmatory testing. And importantly, we also enable each site to include their own local resources. And this is where we direct participants first. All users also get additional information on PrEP, STIs and U equals U. Next slide please.

	Can we go, let me get to... okay, here we go. You're in the right spot.

Patricia:	Okay.

Jennifer Hecht:	[01:27:00] Oh, let's see. There we go. Thank you. This site was built to host as many state and local health jurisdictions as possible. We are very proud to be part of the national demonstration project for home HIV testing distribution that is currently funded through CDC. However, this model is an acknowledgement that most funding for testing flows to the state and local health departments. As noted here, adding a new location is a straightforward process that can take as little as a few days once contracting and payment is completed. [01:27:30] Costs do not increase when new sites are added and targeted promotion means that there's little competition or increased costs as new sites are added. We're pleased to be able to tailor to local health departments needs in terms of eligibility criteria. So we allow local sites to determine criteria such as the times since our last HIV test, the age and a number of other factors. And finally, our app partners prefer to promote the platform that has a wider reach rather than maintaining information [01:28:00] about dozens of sites. Next slide, please.

	We've now sent out nearly 6,000 kits and increase to up to 20 jurisdictions. And one third of our users reported that they had never tested for HIV before. So we're reaching the users we intended to reach. We're working with local health departments to complete new case matches through their surveillance departments. In Oregon for example, we've confirmed seven new cases to date for positivity rate of 0.6%. [01:28:30] And in LA County, there have been a minimum of six new cases for a positivity rate of 0.8%. Next slide, please. This is a breakdown of demographics of participants to date. Note, the demographic data does keep shifting as we add new States and counties with different demographic makeups. Because consistently, however, just about 50% of the individuals we are reaching are under age 30 and over 50% are people of color. [01:29:00] 75% are MSM, 10% are female identified and 2% are trans identified. Next slide, please.

	And here, you can see our reach across the U.S. This model has been working successfully in both urban and rural areas, and new locations are joining particularly in the South. Next slide, please. 

Slide Description:	Promotional Materials

	Examples of some social media promotions from apps as well as takemehome.org

Jennifer Hecht:	BHOC has been able to arrange for a lot of free promotion from the apps. [01:29:30] And this is currently driving about 60% of our traffic to our website. We support and encourage health department partners to promote as well through their community-based organizations, social media websites. And if they choose paid ads. We provide digital assets such as the image on the right for this purpose. And we've created a social media toolkit to support our partners. We also have a share link and over 3000 users have shared this link since we added it. Our conversion rate on the site is close to 10%, meaning that of all visitors to our website, [01:30:00] 10% order a kit. Now this may not sound like a lot, but it's very favorable when comparing to industry standards, which are about 3% for healthcare. Next slide, please.

	In January, we were able to add lab based testing. So to share a little bit more detail about that model. From the health department perspective, each site chooses which packages they'd like to make available to their constituents. Each site has its own medical [01:30:30] director of record to provide oversight and follow-up testing and treatment as needed. Local sites are able to access complete results and have electronic lab reporting set up. The user experience is a little bit different from the oral kits process. It can take about three to five minutes and it does require users to set up an account. They collect their specimens and mail them back to the lab and then return to our online portal for their results. Users can also [01:31:00] access instructional videos for how to collect specimens and FAQ is about the process through our platform. Next slide, please.

	We offer three different packages. One offers HIV dry blood spot only one offers comprehensive STIs, including 3-site chlamydia and gonorrhea testing, syphilis antibody testing, and HIV. And a third is a panel for individuals currently on PrEP, which includes HIV and creatinine. The comprehensive [01:31:30] STI kit offers an opt-out for HIV as well as an eligibility screening for HCV. Next slide please.

	And our first few months of piloting the full lab based testing, we found an average time from order to result of 15 days with a range of five to 46 days. We've identified seven positive cases for positivity rate of 13%. And these cases include HIV, syphilis, chlamydia, and [01:32:00] gonorrhea. Return rates are still being calculated due to the time for return. But so far we're seeing in the range of 50 to 60.. Health departments are charged only for the labs that are processed. So if a kit is ordered and not returned, they pay only for the price of the kit, not the labs. And we have now completed our pilot and opened access to any health jurisdiction. Next slide, please.

Slide Description:	Feedback from Participants

	94% rated the experience 5 out of 5, 97% would recommend to a friend. Slide also shows the following quotes:

“I have never been tested. Being sexually active and with the current pandemic this means a lot to me. Thank you so much!” - Latino male, 35, Oregon

“Thank you I am afraid to leave home due to covid and I have babies who I would have to wrangle to come in. This service is a godsend. Thank you.” – Black woman, 20, California

“This meant the world for me. I have been terrified about the prospect of contracting HIV for a long time but was unable to locate a health department near me, and I was scared to go to one to begin with. This was fast, anonymous, and helped me vanquish my fears. I will make safer decisions regarding sex from now on.” Latino/White male, 24, Tennessee

Jennifer Hecht:	We've gotten lots of feedback from [01:32:30] participants who complete our follow-up survey. Some of the main themes we hear about are that testing at home is easy and convenient that users like the comfort and privacy of testing at home. That for many, this is of course their first testing experience that they appreciate the lack of judgment, and that it's been a great way to access testing during the pandemic. Next slide, please.

	This has been a huge year of learning. We are really excited about the possibilities [01:33:00] in front of us as we continue to grow up the program. A few challenges that we're working to overcome includes streamlining the contracting process. This has really nothing to do with NASTAD, but it's related to the fact that all the local health departments have different budgeting and contracting requirements. We're also working to improve our low response rate on our follow-up survey and our surveillance matching process. Finally, I'd like to note some challenges related to costs. With only one point of care HIV test that is [01:33:30] FDA approved there are definitely limited options for bringing down the cost of the each test. At this moment, the same tests that the medical providers pay for $8, cost $28 for health departments to purchase. I'm hopeful that we'll see new technologies that give participants more options and reduce costs for public health. Next slide, please.

	We are continuing to grow and expand our service. In addition to adding new states and counties, we're also rolling out new features. [01:34:00] Our complete FAQ section was rolled out this past week, along with our customer service line and our Spanish site should be up in the next few weeks. We've already translated all the material and collateral and are completing our final testing on that right now. I hope I've been able to share my enthusiasm for this model to show how quickly it's been uptaken and to demonstrate that home testing and self testing provides a great compliment to testing that already occurs in clinic and community based settings.

Slide Description:	Thank You!

	Sign up and learn more at BHOCpartners.org/home-testing

jhecht@sfaf.org

	BHOC Building Healthy Online Communities

Jennifer Hecht:	[01:34:30] Thank you so much for your time. Hopefully I already answered many of your questions, but please do reach out if you have additional questions. I'd like to thank many of our partners, including Natalie Cramer and Kendrell Taylor and others at NASTAD and Patrick Sullivan and Travis Sanchez and others at Emory. And also a big thanks to [inaudible 01:34:50] for organizing this event. Don't forget to follow us on Twitter @BHOCPartners. Thank you so much. And now I would like to introduce our [01:35:00] Dr. June Gipson.

June Gipson:	Thank you, Jennifer.

Jennifer Hecht:	All right.

June Gipson:	All right. All right. We'll get started. I'm the CEO of My Brother's Keeper and Open Arms Healthcare Center, and I'm going to discuss our remote health services. Next slide. So the mission of My Brother's Keeper is to enhance the health and well-being of minorities through leadership, public and community health practices, collaborations and partnerships. And we do this through three main ways. Next slide.

	[01:35:30] So we have three coordinated centers. We have the Center for Research, Evaluation, and Environmental Policy Change, which is located in Jackson, Mississippi, and that center basis, all of the research and evaluations that we do throughout the organization. We also have the Center for Community Based Programs, which is located in Ridgeland, Harrisburg and Gulfport. And this is going to be where we do a lot of our training activities, our prevention activities.

	But for our remote health, it really centers around Open Arms Healthcare Center. Open Arms Healthcare Center [01:36:00] is our primary healthcare clinic, which is located in Jackson, which is the main site, but we also have three satellite sites located in Ridgeland, Harrisburg and Gulfport. And these are our telehealth sites. And we have a statewide mobile clinic that also encompasses tele-health. Next slide. All right, next slide. Next slide.

	So Open Arms Healthcare Center was established in 2013 and it was established the primary healthcare clinic [01:36:30] to emphasize the health and wellbeing of the LGBT community. The clinic is really set up in such a way where we use a clinical community-based model for health care services. And this community led team model actually works for the clinical staff and the community-based staff, work bi-directionally in their roles, and they collaborate to ensure that we can provide the optimal wellbeing for the patient. And it's based on, SAMHSA's standard framework for level of integration and healthcare. And with their framework, it basically sends on primary health care and behavioral [01:37:00] health, where we modify it to have the community base aspect. Next slide.

	So, if you look at that model, we have the clinical care which is going to be our primary healthcare. We have PrEp, HIV care, family planning, men's health, women's health, transgender health, and dental. And then if you look in the center, this is going to be our community approaches. And so this is where a lot of our CDC programs come into play. Our intervention, Sister to Sister, CLEAR, ARTAS, all these individuals are [01:37:30] integrated into the clinic, and then we have our support services, which is going to be our behavior health. And so we have mental health, we have housing, on site food pantry, patient navigators. We have transportation and we have pharmacy. So if you can see, we go across the board to ensure that we're integrating that we are actually addressing the clients or the patient's healthcare needs across the board.

	Next slide. So with all the services that we have, [01:38:00] when COVID hit, it changed how we thought about things. And since, we have to figure out how to do primary healthcare, primary services also community-based and behavior based services through one model. Then the good thing about Open Arms is that we actually were a little prepared. I mean, oddly enough, for pandemic we started doing tele-health in 2015. So those satellite centers were already set up and already in play. Our patients were aware that we did tele-health. So it wasn't something that was so brand new, but the challenge [01:38:30] was going to be, how do we roll everything in? How do we figure out how this should actually go? So of course, the first model that we use and we still have it because we have our satellite, since it's going to be the traditional model, and this is going to be the Spoke and Hub.

	And so this is going to be on-site lab collection. So if they were in Harrisburg or Gulfport in the Southern part of the state, if they needed to see a clinician, but the clinician needed lab work done, they can go into those locations and be able to get the lab work done and see the clinician. Also [01:39:00] safety needs to have more of an examination. We have nurses located at those sites. So if it's something that needs to be heard or seen, and they need to translate to the clinician, that's how we're able to provide the Spoke and Hub model. Next slide.

	When COVID hit, it changed everything. And so we were able to roll our primary health care, behavioral health care follow-ups, and on-site lab collection all into our appointment only tele-health model. And so with [01:39:30] our BHU which is a off-site lab collection, and BHU is our flagship program.

	And this is where we go into the community or you may come into the clinic and we do HIV, syphilis, gonorrhea, Chlamydia, Hep C, Hep B, glucose, cholesterol, all these things are part of a package that you're able to get. So we rolled the BHU into our off-site lab collection. Next slide.

	So if you look at the BHU off-site lab collection, and this is a partnership that [01:40:00] we have with molecular testing, to be able to provide our clients with any array of screenings that we may need. If you can see, it's really broken down based on what the patient may need. So we're able to do the glucose and cholesterol and the Hep C and the HIV, syphilis, gonorrhea, chlamydia, and we're going to just do it in any type of variety. Next slide. Our off-site lab collection also includes an initial PrEP and a followup PrEP.

	And you see for the initial PrEP, we have the HIV, [01:40:30] creatinine and Hep B, also the gonorrhea and chlamydia and syphilis. Again, just based on whatever the patient may need, any combination of services can be provided. Next slide.

	And with the follow-up PrEP we're able to add in the Hep C or even if we need to do... the Hep B, we'll be able to do that. So kind of create a new scenario for us and based on what the patient needed and based on our capacity that we're able to provide [01:41:00] the tele-health regardless of where they are, as long as it fits within the criteria, what we're trying to do. All right, next slide. Our tele-health process also includes a number of interventions. I say that we have Sister to Sister and CLEAR and Healthy Relationships. And so all of these interventions are actually done through tele-health within the clinic.

	And it's been very beneficial to the patients because again, it cuts the time with them having to come into the clinic, but we don't get to miss anything. We're able to provide the whole [01:41:30] services that we're really accustomed to providing. And it picks a different niche for us in what we have to do. Our next program is going to be our aging program, which is for our patients who are 50 and older. So this program started as wellness. We were under the impression that we created a scenario where people were not just coming to the doctor, but that they were well. That they felt happy, that they felt more engaged in life, that this can actually improve their healthcare. But [01:42:00] we couldn't figure out, how we're going to do this particular program because this program included massages and pedicures and manicures. So how do we change wellness over to a tele-health?

	And so we integrated iPads. And so this was something that we liked between our billing aspect of what we do, and our effort would be, we're able to buy them things that they can ask to communicate with us. We can do a more thorough job of understanding how tele-health can really go across [01:42:30] the board. So we purchased them iPads and through that purchase, they're able to do exercise. We also have dinner and a movie, we have social hour and we provide remote monitoring devices. And this may include, blood pressure devices, glucose, temperature, weight, oxygen saturation, wherever that patient or the doctor deems necessary for that patient to be able to be actively engaged in tele-health and that they can collect the data that they need.

	And our last tele-health [01:43:00] process that we've gone through, and this is going to be an absolute newest. Again, we have Spoke and Hub model that deals with our satellite locations. And then we have our. Appointment only telehealth that deals with all appointments that we do include in PrEP. But recently we started out tele-PrEP on demand access. And this is 24/7 access to PrEP start-up. And so basically go to our website, we have a chat feature and you're able to register, get your paperwork initiated, see the clinician, see a patient [01:43:30] navigator, chat, wherever it may take for you to be able to get everything helping going to start it. And with this particular, we also do our PrEP outside BHU. All these things could still be mailed to the patient's home. And because we are capacity building assistance providers, this particular program is of a great importance to us. Because we have to figure out what's going to be the overall cost of implementing a tele-PrEP at, on demand access for community [01:44:00] based organization.

	Because again, that's what we are, that's who we are. So we had to look at what staffing, how much did it take the higher clinician? I mean, how much do you need for navigator? What does marketing look like for this? And what are the lab costs? And we've been fortunate that for our patients there is no out-of-pocket costs for doing molecular, for having the BHU or the PrEP, because everything really rolls into our [inaudible 01:44:27] program.

	But as we move forward with this [01:44:30] and this program actually launched at the very beginning of May, we'll start to look at pretty much the cost of it, how the demand takes, how it was able to increase, how it decreases, what it looks like between Jack'd and Grindr. So we've actually pushed the envelope on this one, marketing from Jack'd, Grindr, Facebook, Twitter, any online access that we can come up with, we'll actually engage the patients and give them an opportunity to be able to do PrEP. So [01:45:00] we're really proud of this program. And I look forward to seeing what's going to happen with it next.

	We're really proud of this program. And I look forward to seeing what's going to happen with it next. And I'm going to wrap up there and move over to Aaron.

Slide Description:	ePrEP for Adolescents and Young Adults

	Aaron J Siegler, PhDAssociate ProfessorDepartment of Behavioral Sciences and Health EducationRollins School of Public HealthEmory UniversityAtlanta, GA, USA

	Emory University Center for AIDS Research

	PRISM Health

Aaron Siegler:	Hey, well, thank you June. That was excellent. And very interesting. I'm going to present on ePrEP. I'm an associate professor at Emory University. Next slide please. All right. So I think we are all aware that a PrEP saturation seems [01:45:30] to be increasing and it has increased substantially. An NHBS cities in 2017 found about 90% regardless of age, among 18 and over, men who have sex with men. Although there were some disparities by race, ethnicity, and PrEP awareness. However, among adolescents, recent survey, 15 to 17 years old found that only 55% were aware of PrEP. So we do have different types [01:46:00] of awareness and different readiness resulting in different populations of MSM thinking about PrEP. Next slide please.

	And I'm going to try to keep moving quickly because I know I'm standing between the food and lunch. So one thing, one initial barrier to getting PrEP was just finding a doctor, willing to prescribe it. Some people have called that the provider preview paradox. So we launched a PrEPLocator in 2016, with 1200 clinics. And there's [01:46:30] now over 3000 clinics that can be easily identified as close to people as geographically possible. And the website has received over 1.2 million page views and over 600,000 unique users. So does a well traffic site and a useful public health resource. We found that most of the... In a user survey, we found that most users visiting the site are actually seeking PrEP or referring into PrEP care. And this has now been adopted by the CDC and making the information sustainable and accessible. [01:47:00] Next slide please.

	So PrEP initiation obviously is something that we have to work on, but PrEP discontinuation is also a substantial issue. So here's analysis we did with Walgreens data or a pharmacy in the Midwest, not to be named even though... So you could see that there are 7,000 persons in this dataset. And what we looked at was coverage [01:47:30] periods of a year where three quarters of the period being covered with prescription refills would be classified as persistent on PrEP. What we found is that in that first year, 56% of people were maintained and perhaps have pretty substantial drop off after one year, but then it wasn't substantially attenuated in year two. You still have about a third of people dropping off PrEP. So PrEP discontinuation is not only an issue, but it continues to be an issue. And as you can see, [01:48:00] overall is 49% discontinuation by year two among users who are 40 to 49. Among younger users, it's less than a third. So 29% are persisting into PrEP care into the second year. Next slide please.

	So here we can see a map of PrEP deserts in the United States. And these are areas that are classified as sufficient driving time that people would generally go to a primary care clinician [01:48:30] in that area. So that's usually that 30 minute cutoff. So everything you see here from the yellow, orange, red and deep red are all drive...one-way drive point cutoffs that are likely going to have a person's less willing to travel those distances. Good news is that there has been an increase in PrEP providers listed. And so we anticipate that the PrEP deserts are shrinking over time, but still geographic issue remains a substantial challenge as you can see. Next slide.

	[01:49:00] And another thing we can see is that as we have more specialized services on the left, we have driving time for people looking for PrEP navigation services. And on the right, we have driving time for people who need to go to a provider that would cover persons without insurance. And so you can see that the desert areas get bigger and the number of PrEP eligible men who'd be classified [01:49:30] as living in a desert increases substantially. And so clearly, the context of care, not just having a nearby provider, but having a nearby provider that meets the care needs of the individuals seeking services is really what's required. And also you can map similarly and we have for by language of the service provider, et cetera. Next slide please.

	So there are a number of cross cutting reasons for non-persistent in PrEP [01:50:00] and HIV treatment care. I do have some animations here. If you can just click through a couple of times, we can see some areas that are... And two more clicks, I think. Some areas that are potentially mitigated by structural changes and these include insurance and cost issues, and then also perceived needs for PrEP and medication challenges or side effects. Then there are this other group... One more click, please. There's this other group that are issues that are potentially mitigated by home or community care. Includes other [01:50:30] events in life requiring attention. People, especially adolescents might find a hard time getting off school, transportation barriers, both within cities and the rural areas, those exist. And then people having trouble navigating care. And then also the stigma that might be perceived when seeking care. So home care can alleviate some of these to some extent. All right, next slide, please.

	So, similar to Dr. Rawls [01:51:00] kind of classification of levels of remote care and tele-health, we can think about remote communication being just a video conference call that would... For prep, that would just, and then in-person labs in person kind of work with a clinic once that teleconference is over. You can also think about a second level that would include remote monitoring, similar to what [01:51:30] June Gibson talked about. And this would include online surveys, remote specimen collection. We work with our partner MTL like many others for this remote specimen collection work to do testing for PrEP care. And then a third level would be remote engagement. And this would target specific outcomes to improve retention in care through technology. Next slide please.

Aaron Siegler:	[01:52:00] All right. So the concept that we wanted to explore was a home care system for PrEP that would allow PrEP to become fully electronic experience. So it would involve a screen or home specimen collection, telemedicine visit, PrEP navigation virtual, and then PrEP prescription pickup, usually through mail, but if somebody preferred to go to local pharmacy, they could. And then a remote engagement system to engage persons in care. And we call the system ePrEP. So ePrEP is currently being [01:52:30] tested in adolescent trials network, at trial 159. And this is, I guess I have some more animations, some more bullets here you have to click through. This includes full telemedicine PrEP. I like to call it PrEP from your sofa. So the idea is that patients are randomized to either tele PrEP or standard in-person PrEP referral. Then the trials being conducted in four States (Alabama, Georgia, Mississippi, and North Carolina), and we developed a mobile app for young men who have sex with men.

	And we did this through [01:53:00] a combination of qualitative formative work, as well as kind of work with app developers and a theoretical framework. And so this mobile app includes telemedicine consultations through our video interface and text messaging interface, surveys that are built into the app to monitor and an automated reminders as different components of care come do. Then you can have automated reminders built in to help people keep track, and then progress tracking [01:53:30] as a way of helping people feel like they're reaching towards a goal. The primary outcome for the trial is levels of tougher diphosphate. So this is basically levels of protective PrEP in a dry blood spot for participants in the trial. And we call that effective retention care. Great. 

Slide Description:	Andersen’s Behavior Model

	Model shows framework of External environment and Health care environment along with the Patient and Health behavior. The study measures include survey or app data and study outcome. Intervention components are app design, referrals, remote care, and clinicians/staff experienced in PrEP care. The external environment shows Competing life activities. Health Care environment includes System factors Pharmacy services; Clinic factors Appointment scheduling and Clinic experience; and Provider factors Trust, Individualized care, and Responsiveness. Under Patient there are the Predisposing factors of stigma, mental illness, substance abuse, and health literacy; Enabling factors of social support, reminder strategies, medication characteristics, housing, and insurance; and Perceived need of health benefits. Health behavior includes Retention in care and Adherence.

Aaron Siegler:	So here we have Andersen's behavioral model. This is what we structured the intervention around. Again, what we do is we use the qualitative process to explore with young, black MSM in South. [01:54:00] Components that they thought should be included, but we use a framework of the behavioral model to help us make sure we weren't missing anything and to structure our findings.

	And so you can see here, the EP symbol are factors in the behavioral model that are accomplished through app design. The little mail icon are things that are accomplished through remote care activities. The linkage are the referrals that we conduct our clinicians conduct. And then the little clinician symbol is simply having clinicians [01:54:30] and staff who are experienced in PrEP care and culturally competent care for sexual minority populations. So you can see that there's a number of factors there. Here we have a couple of screens from the app and one of the key pieces of the behavioral model is this idea of goal setting that people are goal motivated. They like to feel things have been accomplished. So we use this kind of green check box to indicate when people have [01:55:00] accomplished something successfully and then they can scroll down and kind of see what their next task is within the app.

	So here, in order to complete a supplemental paperwork for assistance, there's a photo upload, that's automatic. That's built into the app system. And so that also will have its own set of reminders. So each kind of step of the way, both helps people feel like they're accomplishing something, but also has support and reminders built in. Next slide, please. [01:55:30] And here, similarly, you could see the kind of at one month, there's a follow-up serving consultation. At three months, there's a follow-up survey so people can kind of see where they are and what they have coming up. You can see there's an online scheduler to schedule their appointments times and to reschedule if an appointment is missed. Next slide, please.

	So we pilot tested this. This is now kind of old data, pre-COVID. And largely, persons [01:56:00] rated it acceptable. And acceptable experience, the telemedicine portals that the least acceptable thing was pricking one's finger, which is not surprising. I don't think I necessarily rate a fingerprint as highly acceptable, but I think the key takeaway here is that 93% of participants were willing to use ePrEP and place a standard provider visit. And the majority said, they'd be more likely to remain on PrEP if the system was available. So I think that indicates the promise [01:56:30] of the system. Next slide please. And so here's this flow chart. The key takeaway from this is that we actually had a pretty substantial proportion of people screening eligible translate into a telemedicine visit and be prescribed a previs among young black men who have sex with men in South. And the majority of those picked up a prescription. However, because this was a pilot, we had to discontinue after that first three-month follow up.

	And what happened was we had the majority [01:57:00] of people were either lost to follow up or refused the linkage to care. And very directly, our participants told us, "I want a telemedicine and I wanted to continue doing this." And at the time there weren't very good telemedicine options to refer people into. Now, there are much better ones to refer people into, but I think this indicates the importance of telemedicine and also is a broader lesson that as we come out of the COVID era, we're going to establish a set of norms that patients have an expectation of that type of care and that we may see [01:57:30] substantial fall off or decreased participation in care. If we start to revert back to systems that people didn't prefer and maybe didn't initiate into. Next slide.

Slide Description:	Alternative administration of LAR: patient-level research questions

	Patient preferences for delivery, and whether different by subgroups

· Standar clinic-based care

· Self-administration

· Paraprofessional home delivery

· Pharmacy delivery

Subgroups: SES, treatment history, insurance status, mental health, concomitant health issues, satisfaction with current clinician

Aaron Siegler:	And so, lastly, I'd just like to leave you with this, that as we move into the era of long-acting injectable medications that are probably on the way for PrEP approval, that there are other delivery concerns to think about. As we think about what is it look like to have injectables be delivered in other care settings? [01:58:00] And so this is something that we all collectively need to explore. And that is it. Thanks. I have many acknowledgements for the clinical trials work and et cetera, and funder support. I thank you all and enjoy your break.

Speaker 2:	Thank you so much to the speakers this morning for your excellent presentations. They were very interesting and informative. As was just mentioned, we are going to have a short break and we ask that you come back at 2:00 PM, Eastern 11:00 AM Pacific time. And we'll have a discussion [01:58:30] session entitled What Should the Role of Communication Technologies be in Remote Health? So we'll see you back here soon. Thank you.

Slide Description:	Discussion Session: Modalities & Technologies in STI Remote Health?

	Organizer: Christopher S. Hall, MD, MS

	Discussants: Brad B. Thorson; Hyman Scott, MD, MPH; Anne Gaynor, PhD

Christopher Hall:	All right. Good morning and good afternoon. So thanks to Saki and Raul and Patrick and Patricia and everyone at DSTDP for imagining and producing this pivotal meeting on remote care, as it relates to STI prevention in care delivery. My name is Christopher Hall and I'm an Infectious Diseases [01:59:00] Doctor and HIV care provider with a 15 plus year association with DSTDP's national network of PVCs. And I also serve as a clinical advisory committee chair at the national coalition of STD directors. So important to this meeting several years ago, I transitioned from my role as medical director of two brick and mortar clinics and since have exclusively provided biomed HIV prevention services, including STI care at two multi-state digital health practices. The latest one featuring [01:59:30] the 340B covered entity partnership system. So I've been a personal provider testimonial.

	In a couple of short years, I am truly convinced that through remote health, we have the promise of reaching previously unreached individuals who have never crossed the threshold of our brick and mortar settings. And in some cases don't plan to, just over one and 100 of my PrEP starts is already HIV positive, but has been unaware [02:00:00] and fully 25% of my patients starting PrEP have a positive STI test of one kind or another at initiation. So I've been asked to say a few words about the spectrum of modalities that may support STI prevention and care. After I do, you'll hear from my esteem colleagues, Brad Thorson of molecular testing labs, who also founded a digital health platform known as Kalamos. Intended to bring evidence-based sexual health interventions to patients who need them most. [02:00:30] I've been from Hyman Scott longtime colleague from bridge HIV and SF department of public health, who also serves as medical director of San Francisco AIDS foundation and its sexual health magnet clinic.

	And then Anne Gaynor, the manager of HIV viral hepatitis STD and TB programs from the association of public health laboratories, where she helps strengthen laboratory systems and workforce. So here's a game plan, we're provoking some thoughts in a mere 30 minutes. So after a simplified... [02:01:00] Intentionally simplify level-setting review of the spectrum of available modalities, communication modalities. Which I hope is not too redundant, given the significant detail we've been exposed to in the platform demonstration so far today, Brad will take us to the outer frontier of today's thinking about what remote care has to offer us with a nod to what's called RPM. And I won't define that stress yet. We'll leave that a little bit of a secret. So I'm in an anvil then ground us in a bit of reality. I'm in well identify [02:01:30] the promise and pitfalls of said technologies. And we'll keep us honest about our core commitments and public health.

Slide Description:	Framework & Approach to Discussion

			Determinants: 

· Technologies

· Present

· Future

Remote Health Deployment:

· Assessment

· Screening/Testing

· Treatment

Consequences:

· Reach

· Accessibility

· Acceptability

· Implementation challenges

· Patient satisfaction

· Effectiveness

· Equity

Christopher Hall:	So first, a couple of overriding. That was my little animation, I failed to project to you all. But just a first, a couple of overarching concept. So remote care is unlikely ever to replace all that we do in our so-called brick and mortar settings. Rather think of it as finding that [02:02:00] optimal hybrid of click and mortar. Some in-person, some remote, ideally achieving a hybrid model of STI care that reserves a role and in-person care while exploiting the promise of remote care modalities, technologies and innovation. 

Slide Description:	Overarching Concepts 

Click-and-Mortar quote: *“...**in-person all the time** is inconvenient and a waste of time when all a clinician is doing is looking at a wound or responding to lab results. But **all-virtual** is not great when things are uncertain or patients need to be examined. While there are few silver linings to the horrendous COVID-19 pandemic, one is that nearly all providers and most patients have experienced virtual care and **most have found it useful**. This widespread adoption of virtual care, we believe, will lead to **hybrid models** that we call “**click-and-mortar**,” which combine the best elements of in-person and virtual care to deliver better outcomes and more reliably and efficiently.”*

Reference: “Click-and-mortar is a better model for healthcare,” Richard Lu, Jennifer Schneider, Bob Kocher, TechCrunch, May 18, 2021

Christopher Hall:	So I'm not going to read this quote, but it's from an esteemed academic journal called TechCrunch. Yeah. And it highlights a study of the online musculoskeletal intervention platform called hinge [02:02:30] health in collaboration with Stanford, UCSF, and Vanderbilt that demonstrated a 69% reduction in pain and 58% reduction in depression and anxiety with, I'm sorry, among over 10,000 platform participants.

	I won't critique study here. Here, but I'll leave you with the aching thought that if ortho can demonstrate such outcomes, then we in STD need to get busy. [02:03:00] So now the rest of what I have to say is going to go fairly quickly, but I bucketed the spectrum of opportunities most readily available to our field in a few categories as follows. 

Slide Description:	Modality Spectrum in Remote STI Prevention Services

	Patient communication continuum [Synchronous vs Asynchronous]

	Synchronous (“sync”) — from in-person to video, telephone — communication synchronized in time

	Value to STI prevention & care

· Greater accuracy & content

· Quicker outcomes

· Therapeutic bond

	Asynchronous (“async”) — texting / messaging; “store & forward” — communication interrupted in time

	Value to STI prevention & care 

· Convenience (provider & patient)

· “Set and forget”

· Patient privacy which promotes candor

	Values pivot between modalities

Christopher Hall:	So first we have, first of three, we have patient communication continuum. And again, much of this is redundant, but hopefully it's level setting and simplifying. You have the spectrum of synchronous versus asynchronous method modalities. So while [02:03:30] we talk about synchronous, we're talking about in-person to video and telephone, and these are interactions where the communication is synchronized in time. Now the value to STI prevention and care. And I should say, this is where we could all brainstorm on the value of STI prevention and care.

	So I'm just throwing out a few things. I think what I would like to see as a next step in this whole process is we brainstorm these concepts and then we develop best practices or where [02:04:00] the modalities fit best with the kind of care that we want to give. But when it comes to synchronous visits, there you have the promise of greater accuracy and content of the information that's going back and forth. You potentially have quicker outcomes because the patient is right in front of you. You also have the therapeutic bond of the patient being right in front of you. And then that can be whether they're in-person or whether they're communicating with you in a synchronous mode via telephone or video, you can also establish that therapeutic bond [02:04:30] at that moment. So we get to asynchronous, or async, some call it structured async.

	That's sort of along the lines of texting or messaging, or what's a term of our store and forward. And that's what our communication is interrupted in time. So there you have the promise of the convenience, both to provider and patient sort of the set and forget things. So if I'm a patient, I wake up in the middle of the night, I think, "I have a question about that RPR." I enter that in that question [02:05:00] and the messenger platform go to sleep and it gets dealt with as soon as the provider can get to it, it's sort of set and forget in that way or store and forward. But one of the great benefits of that is patient privacy, which many of us believe promotes candor in terms of what patients are telling us. But as I put here in the middle, the goal is to pivot between these modalities to use each of them when it makes the most sense.

Slide Description:	Modality Spectrum in Remote STI Prevention Services

	Diagnotics continuum [In-clinic vs Non-clinic-based]

	In-clinic — lab-based v POC assays wwo self-collect — patient presents to clinic

	Value to STI prevention & care

· More immediate results to provider

· Control over specimen collection

· Easier to resolve collection errors

· Quality should meet minimum standards

· Data to care

	Non-clinic-based — self-collect (or guided) and self-testing — patient is remote from clinic

	Value to STI prevention & care 

· Venue flexibility

· Patient convenience & privacy

· Economizes staff resources

· Quality should meet minimum standards

· Data to care

Christopher Hall:	So then the next bucket is diagnostics. So the diagnostics [02:05:30] continuum is generally in-clinic versus non-clinic based. And again, there's some overlap here as well because in-clinic we have the lab-based tasks where we send them off to the associated lab or the point of care assays. We can have self collect in clinic, we all know that. Versus continuum to non-clinic base, where we generally think of that as two things. Self-collect and sending those labs to a central lab and versus self-testing and the patient is remote from the clinic. What's the value in either case some of these things [02:06:00] are completely obvious, but I'll just highlight a couple. In persons, more immediate results, you have control over specimen collection, easier resolve collection errors because the patient's right there. But obviously there was the convenience factor, the flexibility of having non-clinic base testing.

	You don't have to have the same staff available for the patient when they come in. But here I put in the middle, a couple of things that I think we all agree are important. Quality should meet minimum standards, whether [02:06:30] we're using in-clinic test or self-collect, feel delivered a home-based testing. And we want data to care in both cases, which is a little bit challenging when it comes to self-testing where the individual gets that result and the provider or the clinic does not. But that's something we sort of have to resolve is when to the self... When is the value of self-testing exceed the importance of having that data to care window? And I'm going to just have one more slide on the therapeutics and delivery [02:07:00] continuum, because we've touched on this.

	So we've talked to our patient, we diagnosed an infection. And what about therapeutics? Obviously, in-clinic or pharmacy dispense in your local area where the patient travels through that service and gets the med is one end of the continuum. The other end of the continuum is where the meds get to the home. They get there by mail or the pharmacy couriers them. They send someone out into a community to deliver that med. But here I want to just highlight, this man here is about [02:07:30] to get his Bicillin delivered in the home, right? Or his vaccine. So this is where I think is like a way for us to really think more about how we can do field-based therapy in the future, especially as copper type of your la comes along. And someone mentioned that already, or we think about Isilon, or we think about vaccines, whether they be for COVID or in the future, gonorrhea.

	We really need to develop those mobile delivery [02:08:00] services. We feel to deliver therapeutics because I'm short on time and don't want to deprive my colleagues of any more of the 30 minutes. I'm not going to go over these bullets. But again, pretty obvious, but I think, really need to be fleshed out and developed into best practices. So with that, I'm going to turn it over to my colleague, Brad.

Slide Description:	Current Diagnostics are Discrete Events

	Chart with the x axis labeled “Convenience” and y axis labeled “Information Density.” Qualitative Surveys and Rapid Tests are shown at the top Convenience low in Information Density. Self-collected, lab-tested DBS is in the middle of Convenience and just under the middle of Information Density. In-person Venipuncture is at the high end of Information Density but the low end of Convenience.

Brad Thorson:	Thank you, Chris. And thank you everybody for giving me the opportunity here. I think I come from a different perspective [02:08:30] than maybe many people on this call for a number of reasons. I represent molecular testing labs who works with many of the groups that are presented before. And my core focus is on self-collected samples, but I'm also a PrEP patient of seven years and came to this space because of an experience of getting tested at SFAF and then also oddly found Dr. Sullivan's PrEP at home study and felt from the media world, we had so many lessons [02:09:00] of making content easier to access, making the services that we provided as seamless as possible. And that, patient collected testing was bound to be something that would be just sort of commonplace. That was unfortunately over five years ago. So I'm still battling at it.

	The main thing that I want to take away is that everything that we're doing now, it may feel cutting edge, but we still have a long way to go. And when asked about the prompt, what is the role of communication [02:09:30] technology and remote screening? What I really centered on was that our current models of collecting data from patients are discrete events and communication technologies give us the opportunity to stitch together those individual events and understand the patient from a holistic level. So I think that the pandemic, while terrible, has been important to pushing forward what's acceptable. I've heard from many providers [02:10:00] who couldn't access, necessarily couldn't access our moleculars' testing kits immediately when the pandemic hit that they were relying on or a quicks so that they could continue prescribing PrEP, or some of them were simply using qualitative surveys to move forward care.

	And where we really want to get to is being able to move all the way from qualitative surveys to in-person data collection, through venipuncture or visits. So my main [02:10:30] takeaway from this is we're taking pictures but what we need to do is make movies. And I use that analogy. Chris, to jump to the next slide. 

Slide Description:	RPM is a Toolkit for Movie Making

	There are 3 events: Centralized, Distributed, and Streaming. The top row is labeled Entertainment and shows a picture Blockbuster under Centralized, a picture of a CD with Netflix packaging under Distributed, and the Netflix app under Streaming.

	The middle row is Diabetes. The centralized event is monthly phlebotomy, daily home test strips is the distributed event, and under the streaming section is smart contacts for glucose level, smart socks for inflammation, and smart watch for activity level.

	The bottom row is Sexual Health. The centralized event is annual physical and OraQuick and self-collect, lab-processed are distributed events. Shown under streaming is smart toilet for urinary health, automated GC ToC via home kit, connected RPR titer monitor, and PrEP/ART adherence monitoring.

Brad Thorson:	To talk about diffusion of technology and where things are going. So I wanted to pick something that I thought we could all pretty easily understand. I think we're all of an age where we went to a blockbuster at some point in our lives, and I'm not predicting that in-person phlebotomy is going anywhere. But I do think that the evolution of [02:11:00] how we get our entertainment is something that is going to be overlaid onto healthcare. And as Chris mentioned with hinge, I think the diabetes space is also really indicative.

	So don't need to cover the story of blockbuster to Netflix. I think we're probably pretty familiar with that, but we're seeing some really exciting, interesting things happen in the diabetes space. Obviously home test strips were a huge step forward for the patients, but we have companies developing smart contacts that will be able to [02:11:30] record glucose level throughout the day. We have smart socks that can check for inflammation, body temperature. And we also have tools like the smartphone and the smartwatch that create the streaming data that a provider doesn't always need to check in on on a regular basis but provides an indication of when there might be need for more clinical care or what is the range of services that should be offered to this patient. So really what I want to do, and I know we're [02:12:00] really tight on time. So, is explore what that might look like in sexual health.

	Today, we know that we're a quick and self collected lab process samples are possible to extend the number of diagnostic events that we have for patients and prep has been super impactful and showing us that quarterly testing does allow us to identify a lot more sexually-transmitted infections. But I think what we have an opportunity to look for or look towards as a group are innovations that are going to change the frequency [02:12:30] and the amount of data. So things I put asterisks next to things that don't exist, but I could very well see happening. Smart toilets that have the ability to track urinary health, whether that's a chlamydia and gonorrhea infection, or just UTI issues, having some sort of home NAT device. One thing that we're already doing but has not been rolled out on any sort of significant basis. And shout out to Karen Wendell for pioneering this. [02:13:00] Is automated test of cure for pharyngeal gonorrhea.

	This is a way to get quick followup testing so that the patient doesn't necessarily have to come back into a clinic for testing. Considering that we have the ability for diabetic patients to be tracking their insulin levels, maybe getting a little bit far over our skis, but having patients who test positive for syphilis and wanting to be able [02:13:30] to track whether or not that treatment is effective and their titers are lowering, giving them the opportunity to collect that sample at home so there doesn't have to be regular in clinic venipuncture. And then finally something that's also available but still really nascent to us is prepping the ART adherence monitoring through self collected samples. Really, we don't know how often and when we should be deploying these technologies but they are a extra data [02:14:00] point that we are only just beginning to learn how to use as opposed to qualitative surveys for the patient or a medication bottle that's tracking how often the patient opens it.

	So really, taking more time than I intended to. But want to throw out. So we use this term RPM, remote patient monitoring. What we really want to do is start building continuous feedback loops that help us better target interventions and reach patients sooner. And that can be [02:14:30] any number of things from connected devices, all the way down to regular surveys of the patient's health. With that, I believe Dr. Scott, you are up next.

Hyman Scott:	Great. Thanks Chris and thanks Brad. So I just wanted to touch on a few potentials as well as challenges with some of the communication technology based on some of the experience we've had in implementing and doing research within this field. So as sort of Brad and [02:15:00] Chris touched on, it really creates this patient centered engagement opportunity where you can meet people more where they are at, and the brick and mortar clinics are not always accessible and not always available. Don't always have culturally competent staff to provide a patient-centered supportive environment. And so this online environment would allow people to be more engaged. The challenge, I think that we have seen particularly here [02:15:30] as well as with in other places is how do you integrate these tools? So we had an intervention that was tested in our public health clinics, and it was not translatable into our clinics once that study was over.

	And so as some of the descriptions of projects that were explained earlier, I think the project in New York city where it integrated with their existing hotline, that also include like dog licenses, [02:16:00] I think we need to be very strategic and intentional about how we integrate our projects and EPIC and implementation locally has been tremendously helpful because in, for example, the Bay area it's used by most of the large health systems. So providers who are within those systems can see care and a STI and HIV data that goes across the system. So how do we merge [02:16:30] these systems and have a way to have translation and communication across these systems that allows us to better coordinate care. And within the health department here, we recently moved over to EPIC. And prior to that, there were 56 different couture systems that have been developed in different groups because they all addressed a single issue that was very focused.

	And in the result of that [02:17:00] though resulted in this fragmentation of platforms, fragmentation of data, and ultimately more challenges, even though it did solve that small problem. So as there become more systems that are universal, and I think EPIC is one example, it's a very expensive example, but how we can have minimize these overlapping platforms so that we can have a more streamlined communication. [02:17:30] And, so I talked a little bit about the sort of couture systems that we've had difficulty in merging across are different systems, both locally in the Bay area, but also as people move back and forth. And I think that one of the programs that sounded really addressed some of these issues was the Denver initiative. I thought that was really an interesting way to think about. So this [02:18:00] is embedded within the health department and involves a HIPAA compliant.

	So Amazon web services that would allow APIs that can allow data to be transferred. And I think that that's really a place where we still have an opportunity. We've learned a lot during COVID around how we can have, as COVID results every day updated in a real time way, where with HIV, for example, it takes two years for us [02:18:30] to have epidemiologists were always behind nationally in terms of our data to drive our interventions and our targeting. And so I think having this interoperability and data sharing and having some standards that can allow us to share data across platforms across jurisdictions in a very rapid way would allow us to send our patients care, make sure that we have coordination [02:19:00] and decrease the burden both on the public health systems, on the providers and on the patients. So I think that was only a slide I had. So, I'll hand it off to Anne.

Christopher Hall:	Can I just jump in before Anne goes? Because we're actually doing okay on time and I wanted to allow you to punctuate a couple of things. I know when... And this is a discussion group, so I'm taking the liberty to do it a little differently and pose a couple of questions so because we have time. But I think [02:19:30] we were talking in our pre session discussions about even the mundane issue of introducing a new platform to a clinic setting and having to have the staff re-key the information into the new platform. That's an actual... That's a real inhibiting factor. I just wanted to kind of throw that in there too. But the other question I wanted to ask you is what is your sense because equity, health equity, of course, importantly comes up all the time. What is your [02:20:00] sense about the digital divide these days? I mean...

	Your sense about the digital divide these days. I mean, folks like to suggest that some folks don't have devices or smartphones or, and then others will say, "Oh yeah, well, they actually do." And what's your sense about how is this digital divide real? How real is it? And what should we be thinking about there?

Hyman Scott:	So I think that there's a different digital divide. I think that when you look at Pew Research data on who has smartphones [02:20:30] and who's using it for internet access and data plans allow internet access when sort of landlines and Ethernet access made it more challenging in certain communities for internet access. So when you look at those data, there are no real racial, ethnic divides in terms of who has a smartphone and who has a data plan. What we come up against though is how long does somebody have that number? When does that data plan [02:21:00] expire? And is it recharged? Are people using WiFi? And I think that gets into more of a social economic divide that is sort of like the constancy of access. So if you have an app that is dependent on somebody having a data plan and that phone either gets lost, stolen or replaced, and that app is gone and you're going to have interruptions and sort of the data collection, I think, this is some of the patient centered piece where perhaps it's more based on SMS [02:21:30] interactions with individuals.

	So I do think that there are some divides there. I think from an age standpoint, younger people are more likely to have smartphones and have apps. I think the COVID pandemic has changed the way that everyone including older individuals engage with technology as that's how we stay connected during the pandemic. But I do think that we still have a lot of disparities [02:22:00] in terms of sort of constancy of cell phone use and cell phone number. So in my clinic, I would say that probably 75% of my patients have a different phone number every year or two.

Christopher Hall:	Great, thank you. Those are really, really great, helpful insights. So I'll do your job now and turn it over to our colleague and Gaynor and sorry about the numbering on your sides. [02:22:30] I'll take responsibility for that error, but this is Anne's slide. Let's see. And the numbering does work on Anne's slides. So here we go. Okay. Take it away.

Slide Description:	RPM is a Toolkit for Movie Making

Anne Gaynor:	Thank you, guys. So just two quick comments to start us off. Chris made a comment at the beginning about challenging us sort of to make sure we're meeting the minimum. And I would say let's challenge us to meet more than the minimum and I'll talk about balance. So [02:23:00] we also, we heard a lot of great things and I think everyone's trying to find the perfect solution. So and Hyman highlighted this with HIV data and taking two years. So don't let perfection be the enemy of good enough in trying to find the balance between those two. So with that, I just like to say that my remarks here focused mostly on quality testing. I'm coming at this from the public health standpoint, but with a lens on the laboratory. And so we just really want to make sure that whatever remote STI care, including HIV and we'll mention increase access [02:23:30] to people that are either not able to, don't wish to, or otherwise are not seeking care in our sort of brick and mortar settings.

	They have access to testing that still meets quality standards. And to clarify what I mean by that, if someone can't travel to the clinic, they should be getting testing that is equivalent to, or made aware of any limitations to that data as opposed to if they did that testing at home. And I bring this up because there's actually only, I think we've heard this a couple of times, but there was only a single FDA approved or cleared method that includes self collected specimens [02:24:00] in a non-clinical setting. And that's the HIV or a quick, and while we hope to assist diagnostic manufacturers in obtaining home collection claims on these assays, this will likely still take several years.

	So what that means right now is that any test offered by any commercial labs, specialty lab, public health lab, et cetera is considered a laboratory developed test. And it must be validated by that laboratory for that purpose. I won't go into the details of it, what all validation includes, but it doesn't involve making sure the collection process, the sample type, the sample media, the shipping, the testing, the reporting, [02:24:30] et cetera is all validated for every organism that you're looking at.

	And so one thing that evaluation does not assess is clinical sensitivity. So as we think about sort of how sensitive or specific a given test is an FDA approved assay goes through a clinical trial, whereas a validation in a laboratory does not. And so just being mindful of sort of the differences with a lab developed test. The last piece in just trying to wrap up here is sort of the role of the public health laboratory and [02:25:00] they sort of can take on two very important roles in this setting. So they can both be a tester if you will and an advisor. As the tester, they can be allowed that validates this testing, as Karen Wendell mentioned this morning, they worked with their laboratory, didn't ultimately work out in the short term, but public health laboratories can validate these specimens for these different tests. And but the second is really as an advisor, right?

	So a lot of health departments are looking at how to get into this space, how to make sure that they can increase access to people in their jurisdiction. [02:25:30] And the public health laboratory has laboratory scientists who are experienced in performing these validations and understand what is needed and are available to sort of help review what the health department needs are and making sure that the needs are being met by the testing being offered. And so just a reminder that they are a great asset and I will put into the chat here, a resource that was recently published by NASA and APHL looking at self testing strategies and there was both a webinar and a [inaudible 02:25:57]. Thank [02:26:00] you.

	You're on mute, Chris.

Christopher Hall:	Thanks, Anne. I really appreciate it and thank you to our discussions. And I think, Anne, you're a part of this is a great segue to our next speaker, who is your colleague and our colleague, Ellen Kersch, from CDC talking about laboratory perspective on at-home specimen collection or self-testing for STI. Why we'll spot share?

Ellen Kersch:	[02:26:30] Thank you. I appreciate this intro.

Julie Graves:	Give me a second, Ellen. I'm loading it up now.

Slide Description:	A Laboratory Perspective On At-Home Specimen Self-Collection Or Self-Testing For STI

	Ellen Kersh, PhD,Chief, Laboratory Reference and Research Branch, NDSTDP, NCHHSTP, CDC

Ellen Kersch:	[02:27:00] Thank you. All right, so I will be speaking on A Laboratory Perspective On At-Home Specimen Self-Collection Or Self-Testing For STI, and thank you for the invitation to [Sefky 02:27:18] and all others to allow me to speak here. Next slide please.

	So I have no conflict of interest, worked for the government. And [02:27:30] this presentation is based on a review already quote. I'd like to thank my co-authors, Mayur Shukla, Brian Raphael, Melissa Habel, and Ina park for their contributions. And I also like to acknowledge our center's Tiger team on self-testing, which met during the pandemic. Next slide please. So here's the outline of my 20 minute talk. I will cover WHO recommendations for self-testing, go [02:28:00] over some terminology, describe existing solutions and future technologies before a brief discussion. Next slide please. 

Slide Description:	Introduction U.S. STI Testing Volume

· Yearly reported case numbers (million): 1.8 CT, 0.6 GC, 0.1 syphilis

· Screen recommendations and diagnostic testing

· Estimation 14–19 million CT/GC tests annually before COVID: Limited data on actual tests peformed

· Many providers explored contact-less testing services during the pandemic

Ellen Kersch:	So as a brief introduction, I would like to highlight that there's a great volume of STI tests run in the United States. Of course, this audience knows the yearly reported case numbers and how high they are. And we all know that their extensive screening recommendations [02:28:30] for example, for pregnant persons, young women who are sexually active and MSM.

	This means that not only symptomatic people need a diagnostic test, but there are also millions of us citizens who should get a screening test every year. And while we don't have very good data on the actual test volume, it is important to highlight that it is an astonishing number of screening tests that does get done every here in the United States. We estimate [02:29:00] around 19 million gonorrhea chlamydia tests. And this obviously is a clear challenge every year. And particularly during the pandemic, many providers explored contactless testing services as we heard today. And I would like to focus this talk on gonorrhea chlamydia and syphilis because these are the core STIs where there are extensive US screening recommendations and this large testing volume. Next slide please.

	[02:29:30] So our WHO colleagues recently conducted the systematic expert evidence review on the impact of self-testing services. They published a first installment of so called self-care interventions for health and focus on STI reproductive health in it. And they found that programs that offer self-collection increase overall uptake of testing services with a robust risk ratio of 2.9. [02:30:00] Case finding also increased. And they had a very interesting collection of articles in this book, and they described the approach in general, as a people centered approach and highlighted the benefits of one's active participation in one's own health.

	It can reduce burden on stretch systems, worldwide shortages in medical personnel and other barriers as we heard today. So this came out before the pandemic, but I found it [02:30:30] to be worthwhile mentioning how true it was during the pandemic. Next slide please. 

Slide Description:	WHO Systematic Evidence Review, 2019 Impact of Self-Testing Services

	Shown on the slide is the cover of the WHO Consolidated Guideline on Self-Care Interventions for Health: Sexual and Reproductive Health and Rights 

· Prgrams offering self-collection of samples increased overall update of STI testing services (RR: 2.941, 95% CI 1.188 to 7.281) and case finding (RR: 2.166, 95% CI 1.-43 to 4.498)

· A “people-centered” approach which enables active participation in one’s own health

· Can reduce burden on stretched systems with world-wide shortages in medical personnel or other barriers to health care access

Ellen Kersch:	So our WHO colleagues then have these active recommendations out. They do recommend self- collection of samples for gonorrhea and chlamydia should be made available. It may be considered for syphilis as an additional approach to deliver STI testing services. They also recommend it for trich testing, but since we don't [02:31:00] have extensive screening recommendations for trich in the United States, I will not further discuss that technology here.

	So let's talk about laboratory terms, definitions and regulations. So here are the two main relevant models which we have already discussed today. So true self-testing on the left where a person would purchase a test and then do it completely at home. And on the other model is a remote model with [02:31:30] home specimen self-collection where someone would get the specimen at home obviously, and then ship, send it to a laboratory and then interact with some remote telemedicine model. So what is a true self test? We already heard it a little bit. So next slide please. 

Slide Description:	OraSure HIV self test

	Link to self test: www.orasure.com/products-infectious/products-infectious-oraquick-self-test.asp

Ellen Kersch:	Today, but I would be remiss in not showing you the only available STI tests for self-testing at home that is currently on our market. So [02:32:00] this is the OraSure HIV self-test. You can see a picture of it here. It's pretty self-explanatory and it means that the FDA has cleared this test for home use as a rapid test and detects antibodies with an oral swab and provides a result in 20 minutes in the privacy of an individual's home or other settings, but without any professional help so to speak. Next slide. So laboratorians [02:32:30] use terminology pretty strictly as defined by FDA, the Federal Drug Administration.

	So test is only available once a manufacturer submits evidence to the FDA and asks for an approval or clearance, and the FDA will clear it if they find that it accomplishes, but the manufacturer claims that it does. In such an approval or clearance, there is the implicit approval also [02:33:00] of what's included in this test, like the instructions for use, the papers that come with the test. And we refer to that as the package insert. And this document really specifies the intended use and it details which specimens are acceptable and how they are to be collected. So accordingly, a home self- test is a device a person can buy either over the counter or with a prescription. They can then collect their specimen as instructed and perform the test [02:33:30] and get results. It will not require any shipping to any lab. Next slide, please. The STI field can be particularly confusing in this regard because many existing STI tests except the self- collected specimen, but only at a provider with their supervision, for example, a urine or a vaginal swab lend themselves to self-collection. And there's exceptionally good evidence that this leads to good specimens.

	[02:34:00] So the key language here is that FDA clearances for self-collection under provider instruction or sometimes term supervision and that with COVID, you also see it in this word proctoring. So again, this will be specified in the intended use or the collection kit. And a laboratory cannot accept specimens knowingly that didn't follow this procedure, for example, were collected at home, or they risk losing their CLIA certificate [02:34:30] when they are inspected. Next slide please.

	So you may ask what is the CLIA certificate? So CLIA stands for Clinical Laboratory Improvement Amendments, and those are regulations governed by the government, CMS, the Centers for Medicare and Medicaid Services. And their purpose is to establish quality standards, to ensure that patient results are accurate and reliable. So there's one work around [02:35:00] to this so-called lab developed test as many have already alluded to today, particularly and just now.

	So a lab developed test is a test that has not gone through regular FDA clearance or emergency use authorization that can nevertheless be performed locally. So laboratory has to collect data that shows that the test or a modification of an existing test has good performance. So CLIA regulations permit this [02:35:30] if the local clinical laboratory director reviews and approves test performance data according to the regulations, but only for his or her own laboratory locally, which is large burden as was already described today. Next slide please.

Slide Description:	How Have Laboratories Modified Existing STI Tests for Acceptance of Home-collected Specimens?

	Illustration showing circular home test process: Beginning at home the specimen can either be mailed to the clinic which then sends it to the lab, and the lab mails the participant the results, or the participant can email the specimen directly to the lab which will return the results directly. 

	Screen shot of NCSD National Coalition of STD Directors website showing the NCSD Brief: At-Home Self-Collection Lab Testing for Sexually Transmitted Infections.

	GC/CT Testing by Nucleic Acid Amplification Test (NAAT)

· Urine or vaginal swabs

· Tests allow provider-instructed self-collection

· Pre-pandemic trend towards commercial laboratories with automation, high throughput and cost savings

Ellen Kersch:	So how have some laboratories performed such an LDT validation or LDT test modification and can now accept home collected specimens? [02:36:00] This is what is happening in existing remote health models that have sprung up during the pandemic or were there before. So here I'd like to just briefly, before we get into the nitty gritty highlight the excellent work that our NCSD colleagues during the pandemic explaining this process and putting out training and communication pieces that were really super helpful during the pandemic.

	And before I really do get into the [02:36:30] specifics, I want to quickly just state that for gonorrhea and chlamydia testing, we all know that it's done by nucleic acid amplification tests or genetic test as recommended by CDC and they even before the pandemic, were often run in large automated instruments located in remote laboratories. So there's already some commercial interest in such setups for centralized remote labs run these tests, even when they're not [02:37:00] a lab LET modified or validated. So the tests, except urine or vaginal swabs, recommended regular specimen and also some other extra genital specimens as people get to and both lend themselves well to self-collection. So they are currently authorized for provider instructed selection. Next slide please.

	So how to do a lab developed [02:37:30] test modification? There is some literature available. I put picture here on the left of a 2009 document that was developed by APHL and CDC together, and it describes how it can be done. So laboratory has to show that there's no substantial loss in test performance due to the change that is being made here self-collection and shipping. And to do this, a lab needs of course, specimens. And this has been the biggest hurdle in the pandemic, [02:38:00] finding those specimens. So ideally, you'd have two sets of specimens. One collected at a medical provider facility. One at home when you would compare their performance in the test. However, this would require a pretty detailed study design and perhaps even a Harvey review. And that is a big obstacle for any lab to perform.

	It is possible, however, to use leftover or spiked specimens. And [02:38:30] this document details how, in some cases, one can do this with as little as 30 specimens, 10 positives, 10 negatives, and the rest, whatever is available. Next slide, please. 

Slide Description:	History of LDTs for Extra-Genital Specimens

	Screen shots of a major article and editorial commentary from the *Clinical Infectious Diseases* Journal.

Ellen Kersch:	Just want to briefly mention that there's a history for this LDT validation for extra genital specimens, as many of you know in this field. So originally many of these nests were not all of them that's for [02:39:00] not authorized for pharyngeal and rectal specimens, but now they are. And in that time period, many labs that LDTs until there was a collaborative effort by academia and federal funding to submit enough data to the FDA to permanently alter the authorization of these tests. And there is some hope in our field, the same could happen again for self-collection, which would then relieve the burden on all the local labs to do it [02:39:30] themselves. Next slide please.

	So briefly want to discuss syphilis testing without getting into the ins and outs of algorithms. So currently all syphilis testing is done on blood specimens and home collection of blood is obviously a considerable hurdle. So for treponemal tests, the use of dried blood spots can be successful. So I put a picture of a dry blood spot here. It's pretty self-explanatory. [02:40:00] On the left here where someone would pick themselves and drop a few drops of blood on a piece of paper that is then shipped to a laboratory and alluded there and the test is performed at the laboratory. Unfortunately, this method does not work for non-treponemal tests, not in my laboratory. And reportedly also not elsewhere, which is a problem. So one work around [02:40:30] for this has been the use of these microtainers shown on the right here.

	Unfortunately, this requires a larger volume of blood, and that is an even bigger hurdle as people do not like to prick themselves and then ship this volume of test to a laboratory. So in the pandemic, some offers have decided [02:41:00] to only offer a treponemal test with the dried blood spot collected at home. And that can work. However, obviously, a problem with this approach is that if the syphilis pretest probability is high, so many people with preexisting cured syphilis than doing a treponemal test first will not be very efficient because you will get many positives. However, it can work in some settings when you [02:41:30] get only a few positives, you can ask those to come in and do the treponemal test either at the specific laboratory or another laboratory. So next slide please.

	So now I'd like to also discuss if there are tests on the horizon that could be adapted to home use. So this comes from the idea that tests have a spectrum of features. On one end, there are laboratory based tests with big instrument needs, [02:42:00] and then there are rapid tests, a smaller instrument needs and other features. And perhaps those could be further developed into self tests. And the available features of course, are time to result and again, the instrument and how complex is the instrument to operate. There are many exceptions to this in a generalization in continuum. However, in general, this is a fairly accepted [02:42:30] thought in our field. Next slide please.

	So a few more definitions in this context. So I'm using rapid test and point of care test interchangeably here without a clear time cut off and suffice it to say that in our STI field, the focus of the last decade has, in research and development for tests has really been on developing faster tests. So treatment decisions can be made before a patient goes home. [02:43:00] There's also been a focus on giving tests, the so-called CLIA waiver. So this is a label a manufacturer has to ask for and submit data for to FDA and indicates that the test can be done outside of a complex laboratory, usually because it is simple enough to perform by someone who's not a trained lab professional. So naturally, some CLIA waived tests should be good candidates to further develop into self-testing except for when there's [02:43:30] an instrument involved that cannot be sent home. Next slide.

	So are there any such gonorrhea and chlamydia tests available? So for point of care tests, of course there's specific Cepheid GeneXpert, a 90 minute test that is near patient. However, it does have an instrument need and it currently does not have a CLIA waiver, although similar tests from the same manufacturer do have it. Then there is this new Binx IO test, [02:44:00] also a NAAT test, and it takes 30 minutes with the small tabletop instrument to do. That's here on the lower left. It just received its CLIA waiver in March 21. So it just hot off the press. And while it is great in a milestone for fields to have such a test, it is not easy to see how this instrument could possibly be sent home for a home self-test. Next slide. [02:44:30] 

Slide Description:	In the Pipeline (Among Others)

	Image of Visby Medical rapid Gonorrhea test and a screen shot of an article announcing this test wins 19 million dollar prize competition.

	Screen shot of an Infectious Disease article in the Science Translational Medicine Report. The title of the article is “A portable magnetofluidic platform for detecting sexually transmitted infections and antimicrobial susceptibility”

Ellen Kersch:	We're hearing of new tests in the pipeline, but these are not FDA cleared yet, meaning they're not available. So this is future dreams. So the one test this comes up the most is this Visby medical test for gonorrhea alone so not a dual test currently, which won federal money as shown here in this press announcement.

	So it was developed in the context of antibiotic [02:45:00] research resistance work. So this test uses a handheld instrument. You can see it here. Shown as a prototype and not specifically labeled for gonorrhea. That does look like a test that could be sent home and could have some potential for self use at home if it gets approval. There are also notable tests in the scientific literature, further behind in the pipeline, like the one reported just two weeks ago in this [02:45:30] scientific article that had a promise of instrument portability. Next slide please.

	How about for syphilis? So we do have rapid syphilis tests. The caveat is that they're all treponemal tests. There's no rapid non-treponemal test on the United States market. So we have the syphilis health check, does have a CLIA waiver and it's shown here on the top, this picture. And then we have the new Chembio [02:46:00] HIV syphilis dual test shown down here that doesn't have a waiver yet, at least not yet. Both the tests of course require blood, which remains a hurdle. And the Chembio test also has a very small reader need as approved. However, in my opinion, both tests look like they could be adapted to home use eventually pending further development. Next slide please.

	So now for [02:46:30] a few points as a discussion, so one item I would like to mention that restrikes me a significant is the lessons one could learn from the one HIV self test in the long time it took to get it to the US market going all the way back to 1996 when it came a precursor blood foam collection kit was first introduced. And then I believe in 2004, it went to a saliva test and it took until [02:47:00] 2012 to become a self test. And even with that, its uptake was not great until the pandemic. And some hurdles obviously are the blood collection, which is now eliminated, but initially I'm sure contributed to this long timeline, but also the price before the pandemic was generally available for about $40. And there is some research that suggests that if that is an out-of-pocket cost [02:47:30] is probably too high for good implementation.

	In addition, there are issues when there's serial screening like a person needs this test repeatedly. The issue of paying for it over and over is a very significant one. Then for syphilis testing, I do think it will need a different specimen than blood and it would be great if there could be more R and D. There are [02:48:00] some promising scientific articles that molecular detection in the mouth might be possible, or that there are some protein antigens in urine, and it would be wonderful if this could lead to development of a completely new test.

	And finally, I want to just briefly mention that the current amazing number of new self tests for SARS COVID too that are hitting the market in this pandemic. It's an amazing opportunity for us to learn what works and what doesn't. Some items [02:48:30] that I'm following are the development of cell phone apps to help with test interpretation, but also reporting is just amazing. Then the different complexity levels, different costs, different prescription models in billing methods. It's just an amazing time to be in diagnostic test development and follow this. And I do hope that the effects of this will spill over in to our field as well. And with that, I'm [02:49:00] at my last slide. I just want to summarize how I think progress will be made in this field.

	So in summary, the model that has worked similar during the pandemic is to self collect specimens at home and ship them to a laboratory. This works through a lab developed test modification, which is cumbersome. So one, a newer term solution to this could be if an entity were to submit data to the FDA, either manufacturers [02:49:30] themselves or academics or commercial laboratories or some conglomerate of interested parties to show that the method does resolve an acceptable test performance that would be a solution to this problem. And it would spare laboratories having to do these LDTs themselves. In the longterm, I have discussed how a new R and D or further development of newer rapid test could lead to true self test for our field. And that concludes [02:50:00] my talk. I give the word to the next speaker, Julie Graves and she will speak on the evolution of remote care. Thank you.

Slide Description:	Evolution of Remote Care

	Julie Graves, MD, MPH, PhD, FAAPDAdjunct Associate Professor of Management, Policy, and Community HealthUniversity of Texas School of Public HealthPhysician, QCarePlus, a PrEP/STI-focused telehealth practice

Slide Description:	Disclosures

	$Practice telehealth since 2017

	BiasesDissertation on HER Policy IssuesWhite cis-gender woman from Texas, 75h decade, she/her/hers

Julie Graves:	Well, good afternoon and morning, I guess, to some, and thanks very much for inviting me to speak about something I love, which is thinking about history and where we started and how we got to where we are and how some of those lessons [02:50:30] from the past may help us move forward. I do want to disclose that I've been practicing telehealth as my sole source of income since 2017, and that I've been studying electronic health records for quite a while. And I have my own privilege bias and hope that I have addressed it as best I can here. Next slide.

Slide Description:	Photo of the temple of Asclepius. Photo caption: Façade Restauree Du Temple Dasclepios

Julie Graves:	So when we think about where people get medical care, [02:51:00] people have been going to the temple of Asclepius many, many years ago, and getting to medical care has been a challenge in societies all over the world for quite a long time. And although we're talking about some really exciting things that are going on in the US and we're seeing them in UK and Europe as well, we've still got lots of the world that we need to think about in terms of how to get people to care or care to people. Next slide.

Slide Description:	Illustration of ancient Chinese doctors and an illustration of a plague doctor in costume wearing a mask.

Julie Graves:	[02:51:30] We also have a long tradition of clinicians going to people from the frequently spoken of barefoot doctors in China to native American healers, [foreign language 02:51:45] Texas and Mexico. And one thing that I really thought was challenging and interesting about thinking about remote care is that it's all about communication. When the clinician can't [02:52:00] actually get to the patient or the patient to the clinician, then how do we do this? And we get to read fun accounts of how during the play gears of course, people didn't want to travel. Clinicians wore the mask to try to reduce their risk. And when towns in European play gears needed to communicate, don't come to this town that things like smoke signals and solar signals were used before we had a distant communication. Next [02:52:30] slide.

Julie Graves:	And heliotrope much later was developed by Gauss and used as a surveying, but informal heliotropes in reflected sunlight have been used for centuries. And even by our own government in the military in the 1800s in the more rural parts and frontier parts of the US. In the 1800s, we did start to see the SuFIs, the optical telescopes using signal [02:53:00] lamps, and a code was started to be developed. Next slide. And then apocryphal story about Samuel Morris has circulated in which he received a letter that his wife was ill and was a six days journey away. So the letter had taken six days to get to him. And by the time he got there, she had already died and been buried. And that was his motivation for developing and [02:53:30] improving the telegraphic techniques into the telegraph that we know revolutionized communication in the 1800s. And by 1850s in the US, we had over 15,000 miles of telegraph cable. And in the civil war, telegraphs were used extensively to communicate battle information, request nursing services and physician services, talk about supplies that were needed. Next slide.

Slide Description:	Photo of Alexander Graham Bell.

Julie Graves:	[02:54:00] And then we got the telephone not long after that. Alexander Graham Bell developed, patented the telephone in 1876 and three years later, there were medical journals that talked about how we could use the telephone to reduce unnecessary office visits. And today, of course, we would love to do that more, but we run into significant barriers with respect to regulation and payment issues. And then another point that I think we often forget [02:54:30] about when we're thinking about patient care delivery is the value of consultation with peers. I come from family medicine so I worked generally with other people of my same specialty, but I need you, you infectious disease specialists and others who can help me with a case. And we don't also have a great system for how to handle a quick and very helpful office consultation that gets something done for the patient right then. And we [02:55:00] could do something as simple as have a telephone call, but we don't.

	He could do something as simple as have a telephone call, but we don't know how to bill or deal with the administrative parts of it. Next slide, please. 

Slide Description:	Photos of Guglielmo Marconi, a two way radio from 1912, and early telegraph equipment.

Julie Graves:	We got radio Marconi in the late 1800s. By 1912, we had efficient and effective two way radio. And when we think about some of the historical information we have in places like Australia, Alaska where remote [02:55:30] medical services using telegraph and two-way radio could get care to people who were in significantly remote areas in the larger and at that point still developing parts of the world. And the military continued to use telemedicine via radio. As soon as the technology was physically accessible to military physicians and nurses in wars, [02:56:00] really even some in World War II, but lots in the Korean and Vietnam conflicts in subsequent. Next slide.

Slide Description:	1925 cover of Science and Invention magazine showing a doctor remotely diagnosing a patient via a yet to be invented radio and video device. 

Cover Illustration caption: 1925 Science and Invention Magazine representing Hugo Gernsback’s article on his Teledactyl Device.

Julie Graves:	In 1925, one thing I just love about our profession is our shared innovation drive and how in 1925, even before radio and video were developed, that someone imagined the ability to remotely diagnose a patient. Of course, [02:56:30] for me, it's more that I remember the Jetsons and the cartoon and the wonderful video calls that I was so excited about having, and to be honest, still enjoy. Next slide.

Slide Description:	Television 

	1950 Gershon-Cohen Telognosis (teleo, roentgen, dx) Pennsylvania

	Mid 1950s — Nebraska Psychiatric Institute used closed-circuit television to remotely monitor patients

	1959 group therapy, long-term therapy, consultation-liaison psychiatry, and medical student training at Norfolk State Hospital

	In 1964, the two locations established their first interactive, two-way video link

Photo of several old radios and televisions.

Julie Graves:	So we got television in the '50s and Gershon-Cohen coined the term telegnosis combining teleo, roentgen and diagnosis in Pennsylvania, and thought about transmitting x-rays using television. [02:57:00] Now, we think of it as commonplace, but it's within my lifetime that it's been developed. Nebraska, another place that had lots of distances between people started to use closed circuit television in the '50s, even started to do tele therapy and had over time developed video links that we still use today. Next slide.

Slide Description:	Photos of overhead views of Boston Logan airport and Massachusetts General Hospital circa 1967.

· Facilitated remote medical treatment

· Demonstrated that remote diagnoses could be made through interactive television

· X-rays, lab results and medical records could be successfully transmitted 

Julie Graves:	And [02:57:30] NASA of course had to ... Oh, I'm sorry. This is the Massachusetts General and Boston Logan Airport Comprehensive Telemedicine System. 1967, quite a while ago, where a fairly significant link between the hub as we heard earlier today and the spoke, the airport, so that remote diagnosis could happen quickly. Next slide.

Slide Description:	NASA

· 1960s Telemetry

· 1973 STARPAHC

· Papago reservation southern Arizona

· Disaster relief

· Spacebridge to Russia 1991

Photo of young woman in an NASA uniform with a space shuttle and NASA flag in the background.

Photo closeup of the NASA/HIS/LMSC Papago STARPAHC logo

Julie Graves:	NASA of course needed telemetry. There was such concern in the early part of the space program about [02:58:00] monitoring, especially cardiac and respiratory parameters of the astronauts and the development of telemetry came out of their need for remote monitoring. And then of course, we've adapted it to hospital care today. And many of us have been hooked up to telemetry and are so glad that it didn't actually require a physical tethering to the bed. But we got such better information with the ability to use wireless. 

	And I will say [02:58:30] that I neglected to include a slide of Hedy Lamarr, the actress, who was instrumental in developing the frequency scaping technology that allows us to have wifi and communication. NASA also participated in the '70s in a wonderful program with the Papago Reservation in Southern Arizona called STARPAHC, where telehealth was employed with great success. NASA has also used telehealth in disaster [02:59:00] relief and in helping a space bridge to Russia when the Soviet Union fell apart and there was such difficulty getting care to people. Next slide, please.

Julie Graves:	And I'm so happy. This is my only all words slide. That by the late '60s and '70s, we got a lot of federal investment in these research and development programs all over Maine, Puerto Rico, Minnesota, Alaska to try to develop these robust telehealth programs. [02:59:30] Next slide, please.

Slide Description:	Photo of Julie Graves’ mother

Julie Graves:	I will tell a little story. This is my delightful 83-year-old mother. She's a retired school teacher, and you can tell that she's a very sweet and friendly woman, and she really enjoyed her career teaching young children. And I remember in 1967, I was 10 and I had strep throat. She diagnosed it. She's a school teacher and a mother. She knew what I had, and I can [03:00:00] remember her on the telephone arguing with our family doctor that she didn't need to bring me into the office, that she knew exactly what was going on and she needed him to call in a prescription. And I think all of us who are clinicians have been on the other end of that conversation and wondered what is safe, what is effective and when we think about how long we've been developing telehealth solutions, I think that I would like us to think that we're ready to do this for patients who want it. 

	My mother had two kids, [03:00:30] a husband, a house, and a job to handle and she knew exactly what I had. She was a trusted patient with a relationship with the doctor. In SDI care, we often don't have all of those criteria, but we do know that we take care of a lot of people who have trouble getting time off work or might lose their job if they come into a brick and mortar clinic during the workday, which is when we're open. And what are they supposed to do about childcare and can they pay to park? And so I remember someone really struggling, [03:01:00] my own mother and by the way, my physician did call in the prescription and I got better. So next slide, please.

Slide Description:	Timeline of progression from telegraph to internet. Timeline shows the following invention dates: 1838 Telegraph, 1876 Telephone, 1897 Radio, 1927 Television, and 1/1/1983 Internet.

Julie Graves:	So when we think about it, it hasn't been long that we've gotten lots done from the early 1800s with the telegraph until 1983, when we had what we think of as the official beginning of the internet after we'd had a [inaudible 03:01:26] and some other programs. But when we really started to get [03:01:30] internet that was functioning among institutions. Next slide, please. 

Slide Description:	Rural emphasis

· 1990 Seattle Maritime Health Services — fishing

· MedNet

· 2002 Texas Telemedicine Board

Photo of the Golden Alaska fishing boat and an illustration of the state of Texas showing locations of state supported living centers.

Julie Graves:	What I want to point out is that until really recently, we've really looked at only this concept of hub and spoke that we've had institutions like major academic health centers, generally where the hubs and then things would go out over video [03:02:00] connections to individual clinics. There would need to be a doctor on both ends. There would need to be often a nurse on both ends and consultation was the focus. In Texas, in 2002, we actually had a telemedicine board. I was so fortunate to get to join the chair, Ben Raimer, who's now the president of the University of Texas medical branch at Galveston. And we looked at what we could do with current technology in 2002. And Chris [03:02:30] mentioned the store in forward concept, and it was wildly controversial with legislators and regulators in state government. I was working in state government at the time, and I can remember listening to this idea that someone could go to a nursing home and video patients. 

	And then a doctor who was miles away from this remote rural nursing home could see how people were doing. And there was such concern about whether we would cheat and steal money from the Medicare and Medicaid system in these meetings. [03:03:00] It was really overwhelming to me how much people believed that we would use telehealth to get more money illicitly. And we had a ton of barrier from the regulatory standpoint and the legislative standpoint at that time. The map of Texas that I'm showing you because I am a Texan and I am obligated to show a map of Texas in all of my slide presentations are all of the places that we have that state supported living centers, our ICF MR facilities [03:03:30] for people with intellectual disability. 

	And in the 2010 to 2012 time period, we actually developed a number of video links that got past that academic institution as the hub model and started to look at how were we going to staff psychiatry in these remote areas, how do we get specialist care into remote areas and started to use video connections and found that [03:04:00] we had remarkable benefits. For example, in children with severe intellectual disability, having a psychiatrist come into the room triggered a number of behaviors and led to significant overmedication. So we were so excited when we implemented the video observation model and found that our psychiatric drug cost drops dramatically in our state budget. So at that point we started to get some regulators and legislators a little bit more interested in maybe we weren't trying to gain the system. We were actually trying to do something to help people. Next slide, please.

Slide Description:	Specialty care

· Derm — NLM High Performance Computing Communication

· Critical care — hub and spoke

· Cardiology — peds echo

· 1989 — first defibrillation by telephone

· Anesthesia — Gravenstein — laser mediated telemed anesthesia

· Psychiatry — Hanover NH and Claremont...

Julie Graves:	[03:04:30] So we did, I think, as I'm talking about really focus early on about specialty care and certainly many of us need the kind of specialty consultation that's available from our HIV specialists. But for most of us in primary care, we feel very comfortable with managing, testing, treating STIs, and then working with our local health department to try to get the reporting handled efficiently. Next slide, please.

Slide Description:	Photo of Avrim Fishkind, MD

	Doctors on demand logo

	Screen shot from a Texas news website. Title: “Texas prisons try telemedicine to curb spending”

Julie Graves:	And [03:05:00] we did also start to see commercial in innovation. I put up a slide of my friend, Avrim Fishkind, he's in Houston. And he founded JSA Health in 2007. So we're talking quite a while ago and JSA was tele-psychiatry and it was really remarkably innovative in Texas. And what he did was take psychiatrist who are not going to live in rural areas. They're going to live in the city and was able to video connect them with local MHMR clinics all over the state. [03:05:30] And now at even supports, law enforcement who need a psychiatrist to look at someone that they've been called to assess. 

	And I will say that police violence against people with active mental health crises in the communities that JSA serves is actually markedly less than in places where there's not someone with mental health experience going out with law enforcement. So that's something for us to think about in the future that we could expand [03:06:00] for those communities couldn't actually get mental health professionals in person to go out with law enforcement. Then we started to get in 2012, we got a lot more of the commercials. Doctors on demand is that's their logo. We started getting private companies going in and offering, for example, correctional health. Next slide, please.

Slide Description:	Screenshot from HealthcareITNews website showing a headline that reads: “Teladoc drops Texas lawsuit as state adopts new telemedicine regulation.”

Julie Graves:	And things really blew up in 2015 when Teladoc [03:06:30] sued the Texas Medical Board to establish the ability to do the first visit by telehealth. Regulations all over the country had really forced us to do a first visit in person before we could use telehealth, because of a fair amount of, I think, practitioner bias, but also significant payer bias. And so Teladoc used a really remarkable legal strategy that had been used successfully in North Carolina by a dental [03:07:00] association. And the state of Texas actually settled the lawsuit and allowed first visit by telehealth in 2015. So if we think about it, it's really only been about six years around the country that we'd had the opportunity to go as far as we already have on telehealth. Next slide, please.

Slide Description:	Screenshot from Nurx website showing the Nurx logo and the following words: The simplest Way to get Birth Control and PrEP. Real Doctors. Easy Prescriptions. Free Delivery.

Julie Graves:	I worked for quite a while and I disclaimed this with Nurx, which is [03:07:30] all asynchronous telehealth for birth control prep, STI care, HPV screening at home. And I will say that as my private practice, I have found this enormously satisfying and my patients have been grateful, beyond grateful since I started. And I occasionally see somebody who decides they really want in person care and we help them find it. I now practice with ... Next slide, please. 

Slide Description:	Photo of molecules in macro view.

Julie Graves:	I now practice with Qcare, which is [03:08:00] all prep and STI care. And I, every day, get to hear people say to me, "I could never walk into a clinic to do this. People in small towns in Texas that I recognize the name of the town and I know that there's no way that they could get this done anywhere near where they live without significant social consequences." 

	I think of course we had telehealth going prior to the COVID epidemic, the [03:08:30] SARS-CoV-2 epidemic and pandemic, but we got, I think, the opportunity to push forward. And I believe we've made lots of leaps and bounds just in this year on the accessibility. And I heard a speaker earlier and I'm sorry I don't remember who, say some patients aren't going to go back. And I will say that is what I hear every day from my patients. They don't want to go back. They don't want to have to go to a physical place unless it's [03:09:00] not safe to give the care over telehealth. Next slide, please.

Slide Description:	340B Who Runs It?

	340B is a program under the U.S. Department of Health and Human Services. Health Resources and Services Administration (HRSA) oversees the 340B program. Covered entities, pharmacies, and other 340B providers register with the Office of Pharmacy Affairs (OPA). For more information, see hrsa.gov/opa

Julie Graves:	Next slide. Thank you. 340B, we heard earlier about is a marvelous program that supports prep, supports the number of players, including the nonprofits and pharmacies that are part of the idea of getting more care. And the idea of testing for other STIs at the same time [03:09:30] is something that we now seem to have some federal buy-in. My patients are always laughing when I talk to them about how the 340B funding works in their program, because I say, "Well, it got started under Obama, but it didn't go away in the last administration and we're not sure why." Somebody might know. So I would love it if somebody would tell me how we managed to keep 340B in the last four years. Next slide, please. I think I'm almost done. 

	I included some references about some fun articles to read. Next slide, please. [03:10:00] And again, I'm grateful for the opportunity to share what I have to say has been a remarkably fulfilling part of my career one where I am thanked all day long for taking care of people's prep and STI care and giving them the opportunity to get it without the barriers of going to brick and mortar care. Next slide, please. 

Slide Description:	Evolution of Remote Care

	Julie Graves, MD, MPH, PhD, FAAPDAdjunct Associate Professor of Management, Policy, and Community HealthUniversity of Texas School of Public HealthPhysician, QCarePlus, a PrEP/STI-focused telehealth practice

www.qcareplus.com

jgraves@qcareplus.com

Julie Graves:	Okay. Thank you very much. And now we'll hear from Dr. Thomas Gift [03:10:30] about a topic I'm really excited about, which is effectiveness, cost and cost-effectiveness considerations in telehealth. Thanks.

Slide Description:	Effectiveness, Cost and Cost Effectiveness Considerations

	Thomas Gift, PhD and Austin Williams, PhDClinical, Economics, and Health Services Research Branch, CDC/DSTOP

	Remote Health ConferenceCenters for Disease Control and Prevention, Division of STD PreventionMay 24, 2021

Thomas Gift:	Okay. Thank you. So I would like to just spend a few minutes talking to you about some general principles of cost and cost effectiveness evaluation. Next slide, please. So you don't need a definition of remote health at this point. We've certainly heard a lot of those today. [03:11:00] One thing that is worth keeping in mind is that remote health interventions can be technical logically assisted. We certainly heard a number of those that require apps and in some cases home test kits and that type of thing, but then a lot of them are fairly old school, like expedited partner therapy, that qualifies as a remote health intervention or field delivered treatment. And then post-exposure prophylaxis hotline as another. And then specimen collection kits, for course. Next slide.

	So [03:11:30] when you talk about effectiveness, you've got to have some way to do it and some way to measure it. One of the ways that we've heard a lot about today fall into the general category of process measures. These are things that tell you if your intervention is accomplishing what it's supposed to accomplish. Is it working? These are things like patient volume, response rate, the time between initial contact [03:12:00] and follow up, the number of patients tested, the percentage loss to follow up. These process measures are important. 

	Now, I do have an observation there that they're not typically used for cost-effectiveness analyses, but that doesn't mean that they're ignored. If you wanted to put up a testing kiosk somewhere, for example, and patients could come and they could collect or they could pick up specimen collection kits and then they could drop them off in the drop box and where it would be processed. Your process measures would tell you if the kiosk is working [03:12:30] or not. If you only had one kit taken away after the first month, that would tell you that maybe you're not in a high demand location or that there are other acceptability issues. So process measures are essential. Now, you will see some cost effectiveness analysis that use process measures, but that's not the norm. We typically focus on the bottom part of the slide, outcome measures, and I've got the note here for a final outcome. That's just the end point for something like chlamydia testing. 

	We [03:13:00] typically focus on two factor infertility. That's sort of the end. It's not typically a disease associated with mortality. So years of life loss wouldn't matter, but then intermediate outcomes are often what you can observe in the context of an evaluation. This might be numbers of treatment failures, numbers of repeat infections, number of infections treated perhaps. And then the final outcomes. In addition to things like sequelae, quality adjusted life year gained. You see a lot of cost-effectiveness [03:13:30] analyses that use some sort of a health utility measure and that's to enable comparison across different interventions that achieve different health outcomes. Next slide, please.

	Then you have to measure cost. So first of all, what is a cost? When economists talk about cost, they're talking about opportunity cost. It's not necessarily the amount of money that trades hands for a given good or service, although often they are the same [03:14:00] and they're all measured in dollars. And as an example, just consider a clinician ordering a pizza and spending an hour for lunch. The cost of the pizza might be $10 including pizza plus tips, but the opportunity cost of the lunch might be a lot higher because, during the time the person is eating the pizza, it could also be seeing patients and possibly generating additional revenue. So the $10 pizza might actually have an opportunity cost of 80 or $90. [03:14:30] You can hit the down arrow again. Some of these slides have builds. 

	So another fact that it's relevant for cost assessment is who pays the cost. You'll see a term in cost effectiveness analysis a lot that refer to cost perspective. And that's really just [inaudible 03:14:47] perspective are the costs being measured. Now, payer perspective is typically the most narrow that you'll see. It only includes the cost born by an individual payer. And by payer, we're talking an individual health [03:15:00] insurance company like Blue Cross or a CMS or possibly Aetna, somebody like that. The healthcare system is broader and it typically will include all direct medical costs associated with care. And then the societal perspective is the broadest of all. And that includes costs paid by all parties affected by the intervention. 

	And here's what patient cost entered in. And then if you've been listening today, you heard a lot of interventions that are way outside the norm that [03:15:30] we typically deal with in clinic delivered intervention. Patient time costs are going to be relevant. And so they're trying to get some sort of a handle on what types of patient time costs are involved in these different interventions is important if you want to do a societal perspective cost effectiveness analysis. 

	And then the last part of this slide here, analytic/time horizon, you'll see these terms some use them interchangeably. Some will say that they mean different things, but basically this just means you want to value your costs and [03:16:00] outcomes over long enough timeframe to capture the outcomes that are important. The example I mentioned a moment ago with a committee interventions, looking at two factor infertility. Although the infertility might happen fairly proximate to the initial infection, the time that the problem is recognized and received medical treatment, that might be 10 or 15 years down the road so you would want to include a long enough time horizon. The reference there at the bottom is just to the write-up from the second panel and the cost effectiveness and [03:16:30] health and medicine. They talked about some of these issues, the impact of different perspectives and different time horizons. Next slide, please.

	Okay. So now when we get to our outcomes and we get our costs, we can put them together and make cost effectiveness ratio. And there are several of them. The average cost effectiveness ratio is just the cost associated with whatever you're studying divided by the number of units [03:17:00] of health effect, disease cost averted, QALYs gained, whatever you're looking at. An incremental cost effectiveness ratio is looking at changes, changes in costs and changes in effect. This compares to intervention. And an example of think about this from a clinic based intervention might be if you are considering changing from the standard protocol of routinely screening women 24 years of age and younger for chlamydia and going up to age 29 and younger, adding an additional five years.

	[03:17:30] So you would look at the change in costs going from 24 to 29 and the change in outcomes that you would achieve to your cases of infertility, for example. And then after you determine what your interventions are, you have to determine what you want to compare your intervention to. And for remote health intervention, this might be doing nothing or it might be a clinic based intervention. And then the issue of competing versus independent interventions becomes relevant. That competing intervention is one where you have to [03:18:00] make a choice. So the example I mentioned a moment ago, screening up to age 29 or stopping screening at age 24. You have to pick one. We can't do both at the same time. And if you're a mathematician, you're thinking technically you can, that's sort of a different issue. Then independent interventions are ones that can be run together. 

	Many of the interventions we've heard about today could be done instead of a clinic based intervention and that's certainly how they were rolled out in a lot of cases last year when the [03:18:30] clinics were closed. We've heard about the examples from New York City, where a clinic-based care [inaudible 03:18:35] was cut off, but they could also run together. So they're more or less independent and how you treat the differences in cost and outcomes between the two of them will vary depending upon whether the interventions can run together or separately. 

	And as I mentioned a moment ago, oftentimes, evaluating interventions requires you to convert the outcomes into some sort of a health utility metric to facilitate comparison [03:19:00] across intervention. If you're managing a clinic or you're managing a local health department, you're trying to decide what you want to do in terms of delivering care for your patients, what to prioritize next. QALYs is a way to facilitate a comparison between things such as diabetes management and STI prevention. And remote health programs, of course, as you've heard today can include a variety of interventions. You can go to the next slide.

	So some [03:19:30] additional considerations. Scalability is one of them. You may determine that an intervention is most cost effective, but then you don't really have resources to scale up to make that cost-effective at the level that you modeled. And so you may only have resources available for a relatively less cost effective intervention. And then some intervention alternatives may not be able to achieve a desired level of coverage or a [03:20:00] desired level of health outcomes. Some of the options that require patients to request test kits as an example. Unless they're well advertised, you may have some struggle with getting to a certain level of coverage. And then measurement, to measure the cost, there are different approaches. You can do micro costing. You can do time motion analysis. You can look at apportioning parts of an FTE to different activities. 

	Depending upon the data [03:20:30] available, there are different ways to try to determine what the true cost of an intervention might be. And again, given the patient dynamic, if you want to do a societal perspective cost effectiveness analysis, the cost to remote health interventions might be more difficult to assess and something with clinic based care. You can determine how long patients are sitting in a waiting room, but you can't necessarily determine how long it takes them to figure out how to collect their own specimens. And then for remote health in particular, there are issues with connecting [03:21:00] patients. Treatment, which we've heard about today. You go to the next slide.

Slide Description:	Example: EPT

	Screenshot of an original study from a journal. Study is “Expedited Partner Therapy: A Robust Intervention.” Resource: Sheily F, et al. Sex Transm Dis 2010; 37:602-607.

Thomas Gift:	So I'm going to do a quick example to show you some of the issues that I've just covered in a broad sense. You can go to the next slide. Most people are probably familiar with expedited partner therapy. And if you're not, here's a one sentence introduction. It's the practice of treating the sex partners of people with curable sexually transmitted infections without requiring the partner [03:21:30] to first undergo medical evaluation. And it does improve partner notification outcomes for gonorrhea and chlamydial infection. Next slide. 

	So the outcomes that are associated with expedited partner therapy versus just telling the patient who then diagnosed with the STD to refer their partners, that the alternative intervention here. You can look at the different numbers of [03:22:00] partners treated with EPT versus partner referral. You can look at the number of patients who might have repeat infections. You can look at averted sequelae such as PID, infertility and ectopic pregnancy for chlamydia and gonorrhea. Those are typically what we focus on. And you can look at adverse events that might be incurred. This is not referring to sequelae. This is things like the QT prolongation issue that you can get with azithromycin, which may be an issue relevant to consider when you're looking at EPT and you can look at quality [03:22:30] adjusted life here again. Next slide.

	And so there are also some costs associated with EPT versus partner referral, and looks like my cable just got completely destroyed and displayed here, but we can muscle through it somehow and try to find out what's going on here. We've got EPT drugs versus partner examined treatment. So those are going to be different for EPT versus a clinic- [03:23:00] based intervention. Patient repeat visits for treatment, that's relative to consider from the societal, the healthcare system and the individual payer perspective. You've got sequelae in patients, and that's only going to be relevant or the sequelae in patients will be relevant all of the time. 

	But then the bottom part of the slide that's not really showing here, at least not as I'm looking at it as I'm talking to you. Sequelae in partners is a factor as well. The sequelae in [03:23:30] partners and the EPT drugs for the partners, when you're looking at an individual payer perspective, that's only going to be relevant to the extent that the partners have the same payer as the patient when you're doing a payer perspective. This will become clear on the next slide hopefully if that one is not something were really altered, I have some graphics. You can go to the next slide.

	[03:24:00] Yeah, it'll be this slide after this one. So when you look at EPT versus partner referral, using the data that we had from a societal and healthcare system perspective, it was cost saving, regardless. That means it's more effective, it has improved outcomes and it's [inaudible 03:24:21] cost, [inaudible 03:24:22] healthcare system. But when we looked at it from a payer perspective, it varied. This graph depicts [03:24:30] it, and you can go very lightly because I've got a couple of highlights here, if you can advance it one, please. 

Slide Description:	Scatter chart. Reference: Gift TL, et al. SexTransm Dis 2011; 38:1067-1072

Thomas Gift:	So the graph there on the vertical axis, you see the cost difference between the index patient standard referral. So the zero line there that you're seeing on your screen, that's when the cost between EPT and partner referral are the same. When it's above that horizontal line, EPT [03:25:00] is more expensive. And again, this is the perspective of an individual payer. And then when it's below the line is cheaper. The horizontal index is showing you the proportion of the index patients' partners who received care from the same payer. So just think Blue Cross. 

	Blue Cross patient is diagnosed with chlamydia and Blue Cross is wondering if they should pay for EPT doses and partner packs to treat the partners of their patient. They pay for the patient's reinfection, but they don't necessarily pay to treat [03:25:30] the partner if the partner gets treatment. So they send those EPT packs out the door, and that may just be money that they're spending and they're not really recouping any of the medical costs. You can click forward one more, please. 

	So there is a threshold that you see there in the middle of this slide. And in using these data, it was 37%. So that was the tipping point. If 37% of the patients had Blue Cross insurance also for someone who [03:26:00] is hypothetically insured by Blue Cross, this was not something done with Blue Cross data necessarily. That's just an example. More than 37% EPT was cost saving from the payer perspective as well. Less than 37%, not so much. Now it doesn't mean that it doesn't achieve improved health outcomes, it still does, but it doesn't cost less. It might be cost effective, but it's no longer cost saving. You can advance to the next slide.

	[03:26:30] Now, when you do these cost effectiveness analyses, resource allocation decisions that are based on the societal perspective were going to include all costs and benefits to society. And the first panel on cost effectiveness in health and medicine, which was held about 25 years ago, they were very firm that when you're talking about something that's using public financing, it should use the societal perspective. And that just sort of makes sense, but payer perspective analyses show the barriers to implementation. I just gave you an example [03:27:00] of that. You might conclude that individual payers are going to be reluctant to fund EPT, some do in the US and some don't. This has definitely been a factor that has been hard to work through. You can go forward on more.

	And so in conclusion, cost effectiveness analysis is a tool that you've got to have relevant measure. You've got to be able to collect the data that you need or be able to credibly model it. And it requires cost data that [03:27:30] may go beyond budget line items. It may require collecting some data from patients, which can be a real challenge. Multiple perspectives, if you can collect the data to do a multiple perspective analysis, it can identify barriers and optimal strategies. So these things can be challenging to do, but they're important and I would argue that they're essential. I believe almost every single presentation today, if not every single one has mentioned cost in some fashion. 

	Few programs [03:28:00] can receive continued stakeholder support and engagement without a demonstration of cost effectiveness, return on investment. Everybody's looking for that. And then cost effectiveness analysis with that being said can also identify programs that should be discontinued. It's possible to go through a cost effectiveness analysis of the program and learn that the answer is the program should stop and the resources should be redirected to something else. In many cases, a CEA can tell you that redirecting the resources might enable you to improve health [03:28:30] outcomes without any additional outlay. And that's a win, even if it's not necessarily something that is expected. We can go to the next slide.

Slide Description:	Thank You!

	Email: tgift@cdc.gov

	For more information, contact CDC1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348

www.cdc.gov

	The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Thomas Gift:	So thank you for sticking with it through the day. This concludes the presentation this afternoon, and we look forward to seeing everybody at 11:00 tomorrow morning. Thank you.