Ingestible sensor helps identify PrEP adherence patterns
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PrEP pills combined with an ingestible sensor can identify patients who are adherent to the medication and those who are not, according to a study.
“Our group had worked with the ingestible sensor system in tuberculosis treatment. As academic clinicians involved in clinical trials, we were impressed by how safe and accurate the technology was,” Sara H. Browne, MD, clinical professor of medicine at the University of California, San Diego School of Medicine, told Healio.
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“The utility in TB treatment was obvious in terms of a more convenient option for patients than directly observed therapy and the importance of treatment completion to avoid development of resistance,” Browne said.
Browne and colleagues were interested to see if the technology could be useful in a long-term treatment context such as HIV PrEP.
“We wanted to see if patients taking PrEP would use it,” she said. “We were also interested to see if different patient participants had different patterns of medication adherence and what predictors were associated with maintaining medication adherence above a threshold that was clearly associated with successful prophylaxis.”
HIV-negative adults were prescribed tenofovir/disoproxil fumarate/emtricitabine equipped with a digital sensor and the FDA-approved Digital Health Feedback System (DHFS).
According to Brown, DHFS consists of an ingestible sensor and external wearable patch and is paired with a mobile device. In this study, Browne explained that the ingestible sensor — made up of minerals that release a signal associated with electrolyte charges that are identified and recorded on the wearable patch — was coencapsulated with the medication. Taken together, the sensor and the medication “dissolve in the stomach together,” she said.
“The patch records the timing of ingestion events plus physiologic measures that are sent to a paired mobile device via Bluetooth and then automatically uploaded to a secure internet server,” Browne said.
The researchers prescribed the digital pill system for 12 weeks to 71 study participants. They collected and assessed baseline demographics, urine toxicology and self-report questionnaires and analyzed adherence patterns in participants who took the medication for 28 days or longer. Among the 71 participants, 63 (88.7%) persisted for 28 days or longer and generated 4,987 observation days.
In all, 86.2% of doses were confirmed (95% CI, 82.5-89.4), which decreased over time, with an OR of 0.899 (95% CI, 0.876-0.923) per week, although 79.4% (95% CI, 66.7%-87.3%) of participants had at least 80% adherence.
According to the study, an analysis showed that participants who took more than 80% of their doses were more likely to adhere to a regular dose timing compared with participants who took less than 80% of their doses.
Modeling showed that better adherence was associated with older age (OR = 1.060 per year; 95% CI, 1.033-1.091) and a negative methamphetamine screening vs. a positive screening (OR = 5.051; 95% CI, 2.252-11.494).
Browne said the data demonstrate that the technology is “highly accurate and safe,” and was able to clearly identify different patterns of medication taking and timing in patient participants in near real time.
“Visualizations of [these] data may allow health care providers to quickly identify patients to contact to help prevent oral PrEP prophylaxis failure,” Browne said. “Easily accessible visualizations may empower patients and allow compassionate discussion with their physicians to support and inform prophylactic choices over time.”
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