CTN 332 aims to understand the preferences of gay, bisexual, and other men who have sex with men (GBM) and transgender women (TW) related to delivery of HIV pre-exposure prophylaxis (PrEP) care. Specifically, the study will quantify the proportion of participants who prefer a web-based mobile health platform (Freddie™) to standard PrEP care. Freddie is an existing system that was designed specifically for providing convenient, remote PrEP care to GBM and TW in Canada.
PrEP, using regular oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC), is an effective and safe HIV prevention option. Despite awareness, willingness, and early uptake of PrEP in Canada, there are barriers to broader expansion of PrEP programs. In general, there is a need to simplify and streamline PrEP delivery to improve quality of care and patient and provider satisfaction. While the standard of care has shifted to telephone- and digital-based care during the pandemic, these formats require coordinated scheduling and are affected by missed calls and inadequate technology.
Freddie allows for asynchronous contact between patients and care providers, meaning that it does not require both groups to be connected in real time, instead allowing communication over a number of days. The platform also reminds users about necessary lab testing before appointments and includes clinical surveys to capture routine PrEP follow-up information. Prescriptions can also be electronically sent to pharmacies through the system. CTN 332 will assess whether these benefits make Freddie a preferred platform over the usual standard of care.
This study aims to enrol 142 participants in Calgary, Toronto, Winnipeg, and Hamilton. CTN 332 uses a crossover design, meaning that all participants will receive care using both Freddie and the standard approach. At the beginning of the study, participants will be randomized to receive one type of care and, after completing the first 36 weeks of the study, will cross over to receive the other type of care for another 36 weeks (72 weeks total). All participants in the study will receive daily oral PrEP in the form of TAF/FTC 200/25 mg (Descovy®) tablets.
The study team will quantify the proportion of participants who indicate a preference for the Freddie platform over the standard of care at the final week 72 visit. Throughout the study, participants will complete questionnaires about their satisfaction with care and the degree to which they are adhering to PrEP. Adherence will also be measured using a dried blood spot test. The preferences of care providers will also be assessed using questionnaires.
If you would like to take part in this study or want more information, please contact:
Clinical Research Coordinator
Options Lab, St. Michael’s Hospital
Tel: 416-864-6060 ext 77105