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Testing an electronic PrEP initiation and maintenance home care system to promote PrEP among adolescent MSM in rural and small town areas

 

ePrEP logoePrEP is a home-care system for PrEP that allows 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.

Principal Investigators:
Aaron Siegler, PhD, MHS | Emory University

ClinicalTrials.gov Number: NCT03729570

Participants remained in the study for 12 months after randomization.
240 (120 intervention, 120 control).

  • Assigned male at birth
  • Age 18-29 (inclusive)
  • Live in Alabama, Georgia, Mississippi or North Carolina
  • Laboratory confirmed HIV negative
  • Owns an iOS or Android smartphone capable of running the study app
  • Behaviorally indicated for PrEP
    • History of inconsistent or no condom use with more than one partner
    • History of inconsistent or no condom use with one partner who is not mutually monogamous
    • Any STI diagnosed in past 6 months
    • Commercial sex work
    • African American MSM reporting anal sex in the past 6 months
    • Clinician discretion based on epidemiologic context of HIV risk
  • Willing to take daily FDA-approved daily oral PrEP
  • Willing to use study-provided PrEP navigation services
  • Willing to self-collect specimens
  • Full list of eligibility and exclusion criteria available on ClinicalTrials.gov

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.

Findings

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