Actively Recruiting
Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
Led by University of Washington · Updated on 2024-05-10
458
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
T
Tasso Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be eligible to receive PrEP per PHSKC criteria
- Age �3E�3D 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
You will not qualify if you...
- 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 (�3C=7 days) use of anticoagulant medications
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
C
Chase Cannon, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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