Researchers Discuss Ethics and Privacy Concerns About the Growing Field of HIV Adherence Monitoring

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The United States HIV response is moving toward a strategy to increase viral suppression as a means to measure success in improving health outcomes for people with HIV, and to help curb new HIV transmissions. But until we have long-acting antiretrovirals that are easy to implement, the ability to maintain the once-a-day pill regimen will be a challenge for some proportion of the population.

We have several ways to measure adherence to treatment or pre-exposure prophylaxis (PrEP). Some rely on technology, others human labor. These methods include directly observed therapy (DOT), text message or email reminders, self-report, pill counts or monitoring, prescription refills, and even home visits. And there are other ways that involve laboratory testing, whether a blood draw or dried blood spot, urine, or hair follicle. But as technology changes, and the fields of HIV medicine and public health focus increasingly on monitoring viral suppression or drug concentrations in the body for PrEP, the questions about the ethics of certain technologies, their uses, and what happens to that data are still being debated.

On June 18, a morning session at the International Conference on HIV Treatment and Prevention Adherence in Miami focused on the ethical considerations of the growing field of adherence monitoring in the HIV treatment and biomedical prevention landscape.

Adherence Monitoring May Challenge Patient-Provider Trust

Whatever the method of discussing or determining adherence, panelists emphasized the issue of the relationship between parties -- whether between patient and provider or participant and researcher.

"In clinical care research, we often think about a clinician's trust in a patient's authority to report adherence. And therefore, we need to rely on secure adherence monitors to provide a trustworthy account of a patient’s adherence when we feel that that patient  may not accurately reflect their adherence through self-report," said Jeffrey Campbell, M.D., with Boston Children's Hospital.

He went on to describe the reasons why trust is so important in clinical research. But then he raised the question -- does monitoring adherence imply distrust? And does calling out nonadherence break the trust between researcher/provider and participant/patient? Campbell then pointed to different research studies that report differing findings on the issue. Some studies he discussed showed that participants felt adherence monitoring made them feel not trusted, while other participants said it helped them feel that the researcher trusted them more when they had proof of adherence beyond self-report, and that created more trust.

Harald Schmidt, M.A., Ph.D., assistant professor of medical ethics and health policy with the University of Pennsylvania, explained that dynamics of not adhering to medications can be an expression of autonomy for patients or study participants, but in the end, these dynamics can also limit autonomy -- if stricter measures of adherence are taken (i.e., directly observed therapy).

"Patient preferences should come first," he said. "We have a range of options, and those should be presented to patients up front, instead of the other way around."

Privacy in the Era of Constant Data Collection

But beyond issues of trust between patient and provider, the era of adherence monitoring in biomedicine is changing. Most people are familiar with fitness apps that track movement, heart rate, and even diet -- most of which do not fall under HIPAA health privacy protections. In addition to this, tech companies are developing biometric monitors for people who take medicine for chronic conditions like diabetes and HIV. Because people are used to giving urine, saliva, blood, or other bodily fluid samples that go to a lab and are ultimately protected by HIPAA, many patients may accept these technologies without question.

And there are companies developing other technologies that monitor adherence through sensors in pills that emit a signal to a device once a pill is swallowed.

"A lot of patients want to know, 'Who else is going to see this data?'" said Peter Chai, M.D., M.M.S., with Fenway Health in Boston. "One solution is to not only show patients and participants the data they will see, but also what we as clinicians have access to."

Chai also discussed the need for making clear what researchers and clinicians mean by privacy and confidentiality, and what patients mean when they think about those terms. He said this is going to become more critical as new adherence technologies are being developed, through which information flows not just to a traditional lab, but through an app or some other electronic device that is owned by a private tech company.

"What do we do with these end-user licensing agreements?" Chai asked. "Because participants are not only being asked to consent with us as researchers -- but what do we do about start-ups or these new companies that are doing adherence monitoring, and where does the data flow?"

Sara H. Browne, M.D., associate professor of clinical medicine with the University of California at San Diego, who is working on a study to develop a sensor in pills for PrEP monitoring, commented on some of the biometric data collected through newer technologies.

"These technologies should really be used to support people, instead of just [letting] these technologies go loose," she said. "And one of the things we do is give the data to the patients. They should own their data."

These questions about the use of health data with new biometric devices and apps are now being raised in Congress, as a way to bring these new technologies in line with HIPAA protections. On June 14, Sen. Amy Klobuchar (D-Minn.) introduced the Protecting Personal Health Data Act. According to Bloomberg Law, the bill, which "would place privacy restrictions on wearable devices, health applications, and DNA testing kits, would set a new federal standard for biometric consent."