Deborah Kelly : HIV testing at the Pharmacy : The APPROACH Study

guymHIV Endgame 3

Deborah Kelly, Memorial University

Innovations In Testing

How can we reach the 14% of Ontarians—just over 3,000 people—who have HIV but have not yet been diagnosed? This plenary talks about innovative ways to make HIV testing more accessible to more people. What’s the potential to bring these innovations to Ontario? What else should we be doing to reach the undiagnosed?

Descriptive Transcript

Thank you very much. I’m delighted to be here to talk about our project. So these are my disclosures of relevance. Biolytical was is the manufacturer of the Insti HIV point-of-care testing kit, that we used in this project, and they were supportive of our project. And this work was funded by CIHR. So I guess one of the questions that i’m often asked is why pharmacies? Why are we thinking about offering testing through pharmacies? And I think there really are three main reasons why we think about this. I’m from Newfoundland and in Newfoundland you can only get an HIV test if you get it through your family doctor or you have a sexual health clinic that you can go into and if you live outside of the St. Johns metro area there is no sexual health clinic available to you.

The other option is wait till you get sick, you go into hospital and then you get an HIV test there. We did a review of our eight new HIV cases over the last ten years and 36 percent are being diagnosed late with advanced HIV, opportunistic infections, and it’s not good enough. And while we may be a low prevalence province, part of the issue is that there’s just no access to testing or the options are just not very palatable too many people. So the nice thing about pharmacies, is that there’s a pharmacy that reaches or services on virtually every community across Canada. So the other nice thing about a pharmacy is you go in there to pick up a quart of milk, you go in there to pick up prescriptions, you might go in there to get a flu shot, and every pharmacy is required to have a private counseling room. So what happens in that counseling room no one knows, you could be getting your flu shot, you could be learning how to inject yourself with insulin, or you could be getting an HIV test. Pharmacists are health care providers so there’s a certain amount of training and education.

We do a lot of counseling, so it’s a very natural extension, but that’s not to say that additional training isn’t required before you get into offering HIV testing. And we work with other health care providers, so it was natural to think that a good linkage to care could be developed to support offering testing through pharmacies. So these are a few reasons why we explored it, and just so you know we’ve been looking at this model since about 2014, and we’re trying to get funding. So over the course of this time, HIV testing has been offered in pharmacies in the United States, and similar models in the United Kingdom, even for hepatitis C, so while it took us a little while to get out of the gate, we’re not the only ones looking at it.

So let me give you an overview of what our testing model looks like. Number one, even though this wasn’t a study we weren’t actively recruiting people. Instead, what we did was promoted the availability of the test, through the participating pharmacies. So we had one urban, and one rural pharmacy in Newfoundland, and we had one rural and one urban pharmacy in Alberta, who participated in this study. And we promoted the study through posters that were posted in pharmacies, through our community-based organizations, but we relied very heavily on the media. Because we were affiliated with the university, we have promotions people with good linkages to the media. So we had a number of stories. We launched the the project on Valentine’s Day in 2017, with the idea of you know love yourself, love your partner, come out and get tested and know your status. So we had a lot of support there, and we also did some promotion through social media as well.

So basically what happened was people found out the testing was available, and then they visited one of the pharmacies, either during advertised testing hours, or they could make an appointment. The pharmacies in Alberta only did testing by appointment, but in Newfoundland it was by appointment or by drop-in during the testing hours. And basically we would offer the test to any adults that came in who could give consent, who had never before had a positive HIV test, and we also asked for provincial health card number. Not that this was billed, but that was for the purposes of linkage to care in the event that we had a reactive result. So people were screened, in addition to that we were giving them pretest counseling that basically described this is how HIV is transmitted and the tests that we use today will give you a result very quickly, but the limitation is that if you’ve had an exposure in the last three months it’s possible you might get a false negative.

So we weren’t asking people what their risk was, but we did give them the information about how HIV was transmitted, and we asked them if you thought you may have had an exposure in the last three months, then you should let us know because that’ll influence the interpretation of the test. And then we checked that people were actually ready to receive the result then and there. So they had the opportunity at this point to back out, before actually going forward with the testing. And if everything was good with the client at that point, the testing was administered, and then based on the interpretation of the result, linkage to care happened. So in the event of a negative HIV screening test, with the Insti result, it was explained to the individual this was a negative test which means that it’s you don’t have HIV infection at this time point. Here are some steps that you can take to protect yourself in future.

And by the way did you know that other infections are transmitted the same way as HIV and you should consider getting tested for other sexually transmitted infections. And we had pocket cards done up that people could take away to know where they could get testing for the other STBBI in their community. In the event of a reactive test, the plan was to explain, interpret the the test result, indicate this is a screening test, it’s very likely that this represents a true infection but we need to confirm it. And so we had Pleet prefilled blood work requisitions available at the pharmacy, and then the pharmacists talk to the client about, okay so when do you think you can get your confirmatory blood work done?, Where are you gonna get it done? Are you gonna go to the lab?

Do you want somebody to come into your home to draw the blood? So we really problem solved with them to figure out what their plan was going to be, and as well the blood work was ordered by a nurse practitioner or a nurse in the community. So at this point the pharmacist was not responsible for delivering the result of the confirmatory tests, and the client was told that the nurse would be in touch with them within 24 hours to let them to follow up to make sure they were able to get the testing done, and to answer any questions. And as well, we had community supports available for anybody who needed emotional support. So I really want to just take I guess the buld of time to talk about the rollout and the preparation because the testing model itself is really quite simple.

In terms of how it all flowed. But there was an incredible amount of home and legwork that went into the behind-the-scenes in setting this program up, so that it would flow well. The first thing we had to consider were the regulations and the standards of practice. So obviously we needed to look at whether this fell into the the scope of practice for pharmacists, and these regulations are provincially determined. So every province has a different set of regulations and standards that need to be checked, and it’s not just pharmacy standards around pharmacists scope of practice, but it’s also laboratory standards. Who can order STI HIV testing in every province, because that influences your linkage to care plan as well and oftentimes when you’re looking at the regulations point of care testing is not even discussed. We don’t have regulations in every province, so then it becomes a really frank discussion with the Pharmacy Board or the colleges around.

Do we have an agreement that this falls within the scope of practice and that you know pharmacist will be covered under the liability if there is any issue that goes wrong. So these are the things that nobody really wants to spend a lot of time dealing with and make you want to pull your hair out, but they’re really critical because there are some provinces that have not said that it’s okay for pharmacists to do this testing. So that due diligence is really necessary. The other thing is making sure you’re doing it right. So if there are no standards of practice, we had great partnerships with the provincial public health laboratories in Newfoundland and Alberta, and they helped develop the training programs and the the competency testing standards and things like that. So everybody really felt comfortable, and importantly the pharmacists doing the testing felt assured that they were capable and supported in doing the testing.

The linkage to care plans were really critical as well, because we felt that it would be irresponsible to offer a screening test in the pharmacy and then not have good follow-up in place for any clients that had a reactive test result, but even if they didn’t have a reactive test result but it triggered some trauma or some type of emotional reaction, we wanted to make sure that those supports were in place. So we had provincial advisory committees in each province that were comprised of stakeholders from public health, I’ve mentioned, our community-based organizations, from healthcare workers who work in sexual health clinics, with the HIV clinics, and people with lived experience who are at risk of HIV, who informed the development of these plans and said you know this is what’s needed this is gonna work this isn’t what’s gonna work and so the linkage to care plans were really tuned or adjusted depending on what was available in that province and in that region, because we want to make sure that we’re not creating a project that continues for six months then when it’s done everything falls away and it couldn’t continue. So it was really important to use existing community supports.

Next we took a look at the pharmacy training program, and the pharmacists training was comprised of three components. So all the pharmacists participated in online HIV 101 training that basically made sure that they were well versed in sort of the basics of HIV and the treatment and the prognosis so they could give proper education, as well as be able to answer any questions that came from clients. Then all the pharmacists participated in a one-day training program which covered… obviously the the process and made sure that they were familiar with the process, the data collection, but the actual process of testing. And it was not only training with hands on and how to use the test, because the test is the easy part, the really critical part is the communication, and putting people at ease, and making them feel supported, and creating that safe environment for people.

So we had sexual health nurses that came in and actually did this part of the training with our pharmacists, and then finally they went away back to their pharmacist and they were observed doing the process from start to finish with a volunteer involved in the study so we could actually identify whether they could appropriately interpret those tests in the testing environment where it would be offered and then they did competency based testing by testing panels of blinded samples. And finally the promotion. So our community partners were really critical, and informing how we could promote the availability of the service, and I’ll talk a little bit about this, in a little bit more about some of the pitfalls with this in a few minutes. So over the course of six months we completed 123 tests, over the two provinces.

It’s important to note we actually lost our rural site in Alberta just a month in, and a lesson learned from that, it’s important to have more than one trained tester at any site because you invest a lot in the training and when you then when you lose that person there’s a lot lost with that. Of the clients who came out, 75 percent were deemed to be at moderate to very high risk using the Denver HIV score. So we were reaching folks that should be tested for HIV, and notably 28 percent of the folks who came out were receiving their first HIV test. Now it’s important to recognize this was a pilot study that was aimed at assessing the feasibility and the acceptability of the testing model. We weren’t actually expecting to find any reactive test results however we did find one, and it was found in a rural site in a low prevalence province and this person was successfully linked with care, had confirmatory testing done within 48 hours, was linked with the HIV program within 48 hours, and received supports, and did quite well.

We did both survey based assessments of all the clients that came in for for testing to ask about their acceptability, how they how they perceived their experience, and then they also had the opportunity to opt into a voluntary telephone interview later as well, so we got richer more qualitative data. Over 99 percent, only one client was sort of on the fence but everybody agreed that pharmacy based testing should be continued on an ongoing basis. And the majority also indicated that they intended to go for additional STBBI testing based on the the recommendation of the pharmacists as well, though we didn’t actually measure whether that was was followed through. Clients felt supported, they felt that it was a very professional environment, they felt that they got a lot of education, and they were well informed, and they didn’t require any additional supports beyond what was offered in the pharmacy.

The only negative aspects that came up were the use of the pipettes that are required for collecting the blood with the Insti kit and that’s kind of a recognized limitation with the tests that the company is working to overcome, and that the study paperwork was a little bit onerous, consent forms and things like that, but when you peel it away, people were overwhelmingly supportive of the service, and that the only recommendation that we had was to promote it so more people would know about it, and how to access it. And interestingly what came out overwhelmingly was the comment that there was less stigma associated with going into the pharmacy to get tested versus going into your doctor’s office, or a sexual health clinic. And so it reiterated this original idea about why we wanted to explore the pharmacy based testing model. So these are just a couple of the comments that we heard from people, they felt that it was simple, that we were able to offer a very simple low stress easy testing experience.

Many people commented, especially amongst the first-time testers that this really represented something was acceptable to them as their first testing experience, they felt it was less intimidating and they felt that it was really well done and wanted to see it continue. Many people did comment on the fact that you were getting a result right away, the point-of-care test is a draw which is great, but it was nice to see that the feedback went beyond that, and that people found that the model itself, getting tested in the pharmacy was very worthwhile. So in terms of our challenges and next steps, one of the biggest things is the ongoing promotion of services, so we’ve mapped out different promotional activities, and then the uptake of testing. And what we found was media, so mainstream media, getting a newspaper article, or something on the radio, or doing a talk show, was associated with a big rise in HIV tests afterwards.

And interestingly after this study ended on national testing day last June, we were offered Insti kits as every province was, and the only people that are able to do point-of-care testing in the province right now in Newfoundland are the pharmacists who participated in the study. So while we did 123 tests over two provinces in six months, we did almost 45 tests in one day when we brought it back for national testing day. So we’ve really got to do a better job figuring out how do we let people know that this is a testing option. We obviously have issues to work out around scalability and sustainability in terms of payment for tests. Should this be client paid and people had strong feelings about this. The vast majority of people indicated they were willing to pay for the tests, but there were a lot of concerns expressed around those who should have access are oftentimes the ones who can’t afford.

And in terms of sustainability the pharmacist who participated in the project were not paid. They had to double cover and they donated their time, but from a sustainability perspective this has to be figured out. And so our next steps are really trying to figure out how to integrate this with testing for other STBBIs as well. So phase two of the project will look at integrating testing for hepatitis C and syphilis through the offer of dried blood spot testing. As well as looking at the economic evaluation. So I just wanted to thank my team, all the study participants, and the supporters of the project. Thank you. [applause]