Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
Trial Parameters
Brief Summary
The study's aim is to implement a home-based PrEP (HB-PrEP) monitoring system (self-collected blood and extragenital specimens at home and telehealth follow-up) into a large, urban sexual health clinic while also evaluating the program's clinical effectiveness. Study participants will self-collect blood specimens using Tasso devices, which are currently designated as FDA Class 2 exempt medical devices (similar to a medical lancet). This study will be integrated into King County's Ending the HIV Epidemic plan and generate data to inform refinement, adaptation and scale-up of future HB-PrEP programs. Specific research aims are to: 1. Conduct a hybrid randomized trial to compare the impact of a HB-PrEP program versus standard of care (routine in-clinic monitoring) on PrEP retention over time and use mixed-methods assessments to define the factors that influence HB-PrEP implementation. Hypothesis: HB-PrEP will increase PrEP retention rates by \>10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits. 2. Perform a cost analysis of the HB-PrEP implementation strategy compared to standard care. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC. 3. Develop a qualitative tool to engage healthcare stakeholders and determine the wider scalability of HB-PrEP.
Eligibility Criteria
Inclusion Criteria: * Must be eligible to receive PrEP per PHSKC criteria * Age ≥18 years * Washington State resident * Ability to speak, understand and read/write in English or Spanish * Willing to provide contact information * Willing to be randomized and adhere to study procedures Exclusion Criteria: * Recent (\<4 weeks) "high risk" HIV exposure while off PrEP or symptoms of acute HIV * No mailing address to receive sampling kits * No working telephone number * No smartphone or other device with internet access * History of a bleeding disorder, or current or recent (≤7 days) use of anticoagulant medications * Pregnancy