March 7, 2022 - Video and Transcript: Triggered, Escalating, Real-time Adherence (TERA) Intervention
Transcript is below video:
Nick: Hello everybody, my name is Nick. I'll be your moderator today. We have here Megan and Maurice who are a part of the TERA project that they're going to tell you some more about today throughout the interview.
Nick: So Megan, can you tell me about the goals of the study.
[Shown on screen: Nick - Moderator. Megan - TERA Adherence Coach. Maurice - TERA Youth Advisory Board Member.]
Megan: Yes. So, TERA stands for "Triggered Escalating Real Time Adherence." And it was an adherence intervention for young people living with HIV in the US. For folks living with HIV, low medication adherence can result in pretty serious health impacts, and it can also impact your treatment options long term. So, our goals for the study were first to impact the viral load - meaning, the amount of HIV in a person's body. We wanted to get it as low as possible. And then the second goal was to improve medication adherence, which is taking your medication as prescribed. Typically, one would assume the cause and effect is if you take your medication every day, your viral load would be really low. The main study outcome is really just to compare the viral load and the adherence of those in the intervention and those in the standard of care.
Nick: The outcome of this study will affect, you know, maybe thousands of people, overall, [shown on screen: In 2018 over 40,000 youth ages 13-24 were living with HIV in the United States (CDC, 2020)] which is kind of why I wanted to talk to you, Maurice. Can you share why people living with HIV want a low viral load?
Maurice: You can have less doctor visits, I know for a fact. Once my viral load went down, I went from having to go every - you know, even three months, to six months. You have more access to resources when your viral load is down. Quality of life. I believe it's safe for others who, you may, you know, have encounters with; that is important to have a low viral load.
Nick: So it seems like having a low viral load kind of affects the overall quality of life, who - everyone - that is affected by HIV, and thank you, Maurice for sharing that personal story. It's always good to have someone who's had these experiences at the forefront and working to improve the quality of life of other people, just like that. Megan, can you please explain what the TERA intervention involved?
Megan: The study itself took place over 48 weeks. And all the participants got an electronic dose monitoring bottle or an EDM bottle.
[Shown on screen is a graphic. It shows that TERA is a 12-week intervention. A TERA coach works with participants; there are 3 coaching sessions; and dosing data over time is collected based on if a dose was taken on time, late, or missed. There is an electronic dose monitoring bottle (EDM).]
And that bottle actually tracks a person's adherence. So over time we amassed a pretty significant database of all the participants' daily adherence records, based on if they open the bottle, and when they open the bottle. All of the intervention participants were in up to three coaching sessions, and they also receive daily real time adherence support. So the coaching sessions, - in the coaching sessions, the participant and the coach would often talk about their experiences living with HIV, the things that made taking medicine challenging and easier, and would eventually come up with a strategy to improve adherence. And then in follow up meetings, we talked about how that went, if we needed to adjust the plan, and because we'd have that data of when their bottle was open, we could actually talk about - we made a visual calendar. There was a visual to react to. "Is this - is this - look right, is this how often you felt like you were taking it?" And it could be a cool point of affirmation for people who didn't realize they were taking it as much as they were. The other big piece was real time adherence support. So participants would receive kind of as-needed support, and it escalated. So it started really gentle and kind of subtle and then would get much more direct throughout the day. So if at any point when the bottle was open the support would stop for that day. But the very first adherence support, was actually the bottle itself would light up.
[Shown on screen: A timeline. First item is 1 hour before, the bottle is shown. At dose time, a text is sent that says "What's up?" and then one and a half hour later, a text is sent that says "What's the Plan? Reply a b c d e." 1 hour later - coach follows up. The timeline ends here.]
That happened an hour before dose time. And then at dose time, participants would receive a text message that says "What's up?," and they knew that that meant, oh, it's my dose time. So those were the really subtle reminders. Then if someone's bottle hasn't been opened an hour and a half after their dose time, they'd get a message that says, "What's the plan?" And we've asked that, they would tell us, are you going to take now? Are you planning to take it later? And at that point the adherence coaches would get fairly involved, text messaging the participants.
Nick: Awesome. Awesome. Thank you, Megan for breaking that down. That definitely seems like a very multifaceted intervention that you just broke down for us. And it was easy to understand. It seems like to me that participants did have a lot of support during that program, and I see some new innovations in there with telemedicine, reaching out, so that's really good to hear. Maurice, what do you think about the intervention?
Maurice: I wish it was out when I was growing up. It took me a long time to get where I am, on my road to adhering, and one of the biggest barriers was support. However, even that, like Megan was saying, describing it as a gradual model, whereas it's not invasive, it's not overbearing. You're not drilling in someone's head the way doctors may do, or the way nurses may do, but it's a sense of care, and it's a hand. And oftentimes people - that's all people want, is you know, to see that someone wants to help, and not force you to do anything. So I wish it was out when I was out there, and I really know it because of the informal approach and just the whole clever pill model, it's metaphysical for me, because adherence to me is acceptance.
Nick: Yeah, I know what you're definitely saying is really powerful. And you might be touching a lot of people. I know you're touching me right now. You kind of already like touched on basically some of the challenges that - like - maybe youth who are affected by HIV taking their medication daily. What do you think are some other challenges to that adherence for young people?
Maurice: Right, because yeah, support was more my main access. A lot of time that - everybody - don't have healthcare, as much as it seems that way. The ability to go to the doctor, having the ability to go there and have someone there with you to support you if you, that's what you need. Mental health. I take mental health very seriously, and I think that depression and anxiety runs rampant in our culture and we don't talk about it. And, it's real. So I think those things combined, a lot of people can just be like, 'Why even bother?' Because I've been there when it comes to adherence. And so they just need a lot of support.
Megan: Can I add a few things that I would hear as well?
Nick: Yeah, Megan.
Megan: I think, HIV stigma is so pervasive in the United States. So a lot of folks in this study, privacy was such a big concern, they didn't want other people to know they were taking HIV medication, even within their own families. And another big piece was, we're working with young people 14 to 26, [shown on screen: "Correction: TERA enrolled youth ages 13-24"] and your schedule at that point in your life is changing all the time. So there are people in the beginning of the three months that, they had one schedule, and by the end of the three months they had two different jobs than they did at the beginning, or their car broke down, or whatever changed. That really impacted their daily schedule, and I, you know, it's a big growth period in a person's life. You're entering adulthood, and a lot of people were independent. And so, many people were just exhausted. From the outside looking in, you can kind of make little of, and think, 'Oh, take your health seriously.' But it's really real. Exhaustion is serious and on top of stigmatization. When it - when Maurice you said "Adherence is acceptance," I think that is so, so, so true.
Nick: Thank you both for stating your opinions, and thank you again Maurice for sharing your personal experiences. I do think oftentimes in the realm of public health we do neglect mental health when it comes to any chronic, you know, illnesses and different things like that. I also agree with you, Megan, that, you know, some people don't realize just how much of a burden it can be to put your health first, when your life is ever changing - especially through the times when you're like 14 on the way to 26, [shown on screen: "Correction: TERA enrolled youth ages 13-24"] those are multiple different growth periods in someone's life. Now that the study has concluded, what did you find?
Megan: Like many studies, we were impacted by COVID-19. Originally, we were hoping to compare viral load and adherence at three months to the 48-week mark, which was just under a year. We didn't have enough participants get to 48 weeks. So in the end we just looked at the 12 week mark. And there was actually no effect on viral outcomes. So, at 12 weeks into the intervention, folks in the intervention and the standard of care had similar rates of viral suppression. However, the intervention participants had a pretty significant impact on their EDM (electronic dose monitoring) adherence. So, on average, they were adherent 72% of the time, and the standard of care was adherent 41% of the time, on average. So the intervention ended at three months, and they continued that adherence for another three months. And the other big thing was the participants in the intervention were less likely to have a long gap in dosing. So we measured that as going seven or more days without dosing. So it was much less likely for those in the intervention to have a long gap.
Nick: Yeah, so that can, that can be a lot to interpret based on the findings. So Maurice, what do you kind of make of these results?
Maurice: Like Megan mentioned, it's hard to really pull data during a pandemic. And I'm learning that being educated, it's hard for us really to test and assess people during these trying times where we're not able to give the best we can give. Every day is unprecedented. So I see it to be a great thing that they were still able to adhere in the ways that they were, and for it to be impactful, and the longevity, because that's what I find it to be about. To be undetectable - it's the continuous fight, the continuous, - I worked for that, I didn't come overnight. And it's like, it's not easy, it's really not easy to adhere honestly.
Nick: Thank you for your final thoughts, and thank you again Megan and Maurice for coming today and talking about your experiences with the TERA project and your personal experiences. Thank you all for whoever is watching and taking the time to invest your time into this. We appreciate you as well. And that is all, so we will be seeing you guys later. Thank you. Have a good one.
Text on screen: The Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) research program aims to defeat the HIV epidemic among adolescents and young adults in the United States. ATN is led by investigators with innovative thinking and novel approaches to increase awareness of HIV status in youth and, for those diagnosed with HIV, increase access to health care. Visit https://atnweb.org to learn more
Text on screen: ATN is funded by the National Institutes of Health (NIH) through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), and the National Institute on Minority Health and Health Disparities (NIMHD). Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number U24HD089880. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.