A conversation with Sandra A. Springer, M.D., about the power of patient autonomy in HIV treatment and prevention

Long-acting injectable formulations of HIV pre-exposure prophylaxis (PrEP) may hold more appeal than daily oral pills for people who use drugs and have histories of criminal legal involvement, according to new findings from a National Institutes of Health-funded trial conducted across sites in Texas and Connecticut. The study was led by Sandra A. Springer, M.D., of the Section of Infectious Disease at Yale School of Medicine and lead author of the study. Her and her team found that although overall interest in PrEP remained low among this high-risk population, nearly two-thirds of those who did express interest preferred an injectable option. Factors such as methamphetamine use disorder, self-perceived HIV risk and insurance status were linked to differences in interest and formulation preference.

Springer recently sat down with Managed Healthcare Executive to discuss the implications of this research and why patient autonomy is such a crucial part of the broader healthcare journey.

This interview has been edited for length and clarity.

MHE: Can you please describe the study design and how it was conducted?

Springer: This evaluation was about the baseline data from a large, randomized control trial conducted in Connecticut and Texas of criminal-legal-involved individuals who were either living with HIV or at risk for HIV, who used opioids and/or stimulants.

Participants without HIV were asked about their preferences for preexposure prophylaxis. Would they be interested in the oral, daily pill form or the option for a longer-acting injectable?

The study compared two different mechanisms for PrEP access: a community clinic with a patient navigator, or a one-stop shop, or a mobile health unit where you would have a clinician and a community healthcare worker who could help in the moment get HIV testing, PrEP, primary care services and any other social services.

The whole study was a 6-month intervention with a 12-month follow-up, and we completed the trial at the end of December, with the last bit of data assessed in January of this year. The analysis has been completed, and the primary outcome paper is under review right now.

MHE: What did the analysis reveal?

Springer: We predicted that the majority would not have HIV, which was true. About 95% of the population did not have HIV, but they all had to meet the Center for Disease Control’s PrEP eligibility criteria pre-incarceration: either sharing injection drug use equipment and/or having condomless sexual intercourse with an unknown-status individual or having a bacterial sexually transmitted infection in the last 6 months.

What we found was that, not surprisingly, about a third of the population without HIV were interested in PrEP. Among the individuals who were interested in PrEP, about two-thirds were interested in an injectable form of long-acting PrEP. Lenacapavir wasn't available yet, and cabotegravir came out later during the study.

We've seen time and time again an unhoused person actively using drugs, being told about PrEP, never hearing about PrEP maybe ever, never knowing that there is an injection option, and when you tell them, they choose the injection.

We also assessed their risk behavior. We looked at detailed risk behaviors before incarceration and over time, and there was a very high level of condomless sexual intercourse with unknown-status partners. You can’t forget that people who use drugs also have sex.

If people don't think they need it, even though they report the risk behavior, then that's a whole other area that we need to figure out, and that includes education, which we aren't doing in criminal justice settings. People, for the most part, aren't getting knowledge about pre-exposure prophylaxis before they get released.

We also did a very detailed needs assessment before people were released into the community, which included basic biomedical needs, like primary care, mental healthcare, and dental care, but also socioeconomic needs. Do you need a phone? Do you need a personal form of identification? Do you need transportation? Do you want employment? Meeting those needs may be more important than helping an individual get access to PrEP. Through helping them figure out what it is that they want, could you help somebody get onto PrEP?

I think the reason why we published the data instead of waiting until the primary outcome paper was completed is because it’s evidence that you can't presume you know what people want.

MHE: In the study, you write that understanding patient preference is key for patient choice and autonomy. Can you elaborate on that?

Springer: Criminal-legal-involved individuals are less likely to be on PrEP, especially upon return into the community.

The main area that I've been focusing on is how to get healthcare to people where they want it, where they're literally at, housed or unhoused and actively using substances or not.

We have these lovely, evidence-based long-acting forms of treatment: long-acting antiretroviral therapy, long-acting PrEP and long-acting substance use disorder medications like buprenorphine, but they don't work if people can't get them. And oftentimes, especially with this population, there's a lack of education or a lack of knowledge that's given to individuals, and knowledge is power.

I think it's important to note there are significant differences between the states. In Texas, there’s a lack of Medicaid expansion; in Connecticut, there's Medicaid expansion. There are differences in geography and other harm reduction modalities. Syringe services are illegal in Texas but legal in Connecticut, and there were differences in substance use—more methamphetamine use in Texas, but cocaine use and fentanyl were more common in Connecticut. We also have different criminal-legal systems. Texas participants were more interested in long-acting and more interested in PrEP and injectable PrEP. When they can't get syringe services to reduce injection drug use risk, it's also harder to get healthcare in general.

MHE: What is next for the study?

Springer: The next part of this is to show which of these interventions, a mobile healthcare unit or healthcare navigators in our brick-and-mortar clinics, is more effective than the other.
There are many secondary outcomes, which looked at if one was better at reducing substance use, hepatitis C infection and treatment, bacterial STIs, mental health and overall quality of life. A snippet of it was presented at CROI in a poster format, and it'll be at IDWeek.

MHE: What is one thing you hope people take away from this study?

Springer: My biggest takeaway is patient choice. Don't assume you know what people want. I always give knowledge to people, and of course, I'm going to do shared decision-making. I'm an infectious disease and addiction medicine doc, and I'm not going to keep information from people. If they can't afford lenacapavir, for instance, $23,000 to $26,000 a year for two shots and they don't have Medicaid, they should know about it.

They should be given the opportunity to consider their options and it's up to them to make a decision.

If your patients can't get access to it, if you don't have Medicaid expansion, you don't have a way to get free drugs through the drug company; the other part is you have to get involved.

You’ve got to talk about advocacy, because it's not just the medicine. It's policy, and what's the point of everything that we're doing in research and clinical care if people can't get access to these amazing meds? That's where the Healthcare for Everyone service comes in. We legalized the first mobile retail pharmacy in the United States. It's a retail pharmacy on wheels with a clinic. We're lucky because we have a Medicaid expansion state and most of our patients are Medicaid eligible. I really can give lenacapavir in less than an hour if somebody wants it, plus their insulin for the diabetes and their medication for the blood pressure and naloxone and buprenorphine, and whatever else they need. Don't go out there and just do HIV testing. Figure out what people want and be able to provide them that care.