Abstract
BackgroundDigital pill systems (DPSs), which comprise ingestible radiofrequency sensors integrated into a gelatin capsule that overencapsulates a medication, can directly measure ingestion events.ObjectiveTeaching users to operate a DPS is vital to ensure the collection of actionable ingestion and adherence data. In this study, we aim to develop and pilot a training program, grounded in the Technology Acceptance Model, to instruct individuals on DPS operation.MethodsA two-part training program, comprising in-person and text message–based components, was used with HIV-negative men who have sex with men with nonalcohol substance use, who had enrolled in a 90-day pilot demonstration study using the DPS to measure adherence to pre-exposure prophylaxis. We assessed the number of responses to text check-ins, the number and types of episodes where technical support was requested, the resolutions of such issues, and engagement with the program over the study period. Participant feedback on the program was evaluated through qualitative user experience interviews.ResultsA total of 15 participants were enrolled in and completed the program. Seven technical challenges related to DPS operations were reported across 5 participants. Most commonly, participants requested support connecting the wearable Reader device with their smartphone, charging the Reader, and operating the mobile app. A total of 6 issues were resolved asynchronously or in real time via phone; 1 required in-person evaluation and resolution. Preliminary qualitative findings indicate that both the in-person and remote follow-up components of the training program were perceived as acceptable. Suggested improvements included repeated DPS refresher sessions at in-person follow-up visits and enhanced written materials for the independent resolution of technological issues.ConclusionsA brief two-part DPS training program, drawing from individuals’ experiences and from the Technology Acceptance Model, can provide valuable insights for users. The program also identifies and addresses several areas of actual or potential challenges related to operating a DPS and allows for the resolution of such issues within the first week of DPS use.
Highlights
Digital pill systems (DPSs) use ingestible electronic sensors incorporated into gelatin capsules that overencapsulate medications
For men who have sex with men (MSM) with concomitant substance use, the use of once-daily tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis (PrEP) for HIV prevention has been demonstrated to be highly efficacious; PrEP efficacy remains closely linked to adherence [3]
The parent study consisted of a 90-day, open-label demonstration trial to evaluate the feasibility and acceptability of the DPS (ID Cap System, etectRx Inc) to measure PrEP adherence, in which digital pills for PrEP were deployed among HIV-negative MSM (N=15) older than 18 years who self-reported nonalcohol substance use (NCT03842436)
Summary
Digital pill systems (DPSs) use ingestible electronic sensors incorporated into gelatin capsules that overencapsulate medications. Ingestible sensors are activated upon entry into the stomach and exposure to gastrointestinal fluid, transmitting key data about medication ingestion patterns in real time. These data can be viewed by clinicians and patients via web-based platforms and smartphone apps. Techniques involving mobile apps, social media, and technological devices have been deployed among MSM to discover episodes of nonadherence and deliver interventions to help boost adherence behavior [6,7] The use of such innovative technologies may help overcome barriers to engagement in PrEP care experienced by MSM and individuals with substance use disorder [8]. Digital pill systems (DPSs), which comprise ingestible radiofrequency sensors integrated into a gelatin capsule that overencapsulates a medication, can directly measure ingestion events
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