A randomized, controlled trial of an electronic HIV pre-exposure prophylaxis care system among men who have sex with men in rural and small town areas
ePrEP is a home-care system for PrEP that will allow rural MSM to initiate and maintain PrEP clinical care without requiring travel to a clinician office or to a laboratory for testing. ePrEP combines a home care system for behavioral surveillance and home specimen collection/shipping for laboratory tests with app-based telemedicine and patient management.
240 (120 intervention, 120 control).
- Male at birth
- Age 18-24
- Report anal sex with a man in the past 6 months
- Live in a rural or small town zip code based on census urbanicity classifications
- Able to complete the survey instruments in English
- Provide at least 2 means of contact
- Not enrolled in an HIV prevention trial
- Self-report HIV-negative status
- Own a smartphone capable of running study app
- Behaviorally indicated for PrEP based on CDC guidance
- Not currently taking PrEP
- No history of hemophilia
- Willing to be on PrEP including adherence to daily dosing, and
- Willing to use study-provided PrEP navigation services, if offered, to obtain coverage for PrEP medication
- HIV-negative laboratory test
- Creatinine clearance >59 ml/min
- No symptom(s) that could indicate acute HIV infection
- No contraindications to taking emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
- Hepatitis B surface antigen negative
- Willing to self-collect specimens
The primary outcome is protective levels of PrEP, as indicated by TFV-DP levels. The cutpoint used for the primary outcome measure will be TFV-DP levels considered to be a surrogate for substantial protection: >700 fmol/punch, a level indicating > 4 doses/week. Secondary outcomes will include retention in PrEP care and a number of ATN harmonized measures. We will employ standard methods of cost analyses to estimate the cost, cost-effectiveness, and cost-utility of the intervention relative to standard of care.