Home-based HIV prevention program evaluation
Hybrid Evaluation of the Implementation and Effectiveness of Home-based HIV Pre-exposure Prophylaxis Monitoring in King County, Washington
NA · University of Washington · NCT05856942
This study is testing a new home-based program that helps people at risk for HIV use a prevention medication more effectively by allowing them to collect their own samples and have virtual check-ins with healthcare providers.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 458 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05856942 on ClinicalTrials.gov |
What this trial studies
This study aims to implement and evaluate a home-based PrEP (HB-PrEP) monitoring system that allows participants to self-collect blood and extragenital specimens at home, followed by telehealth consultations. The program will be integrated into a large urban sexual health clinic in King County, focusing on improving PrEP retention rates among individuals at risk for HIV. By comparing the HB-PrEP approach to standard in-clinic monitoring, the study seeks to identify factors influencing the implementation and effectiveness of this innovative care model.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 and older who are eligible for PrEP and reside in Washington State.
Not a fit: Patients who have had recent high-risk HIV exposure or those without access to necessary technology for participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve access to HIV prevention methods and increase retention in PrEP care for at-risk populations.
How similar studies have performed: Previous studies have shown promise in similar home-based health interventions, suggesting potential for success in this novel approach to PrEP monitoring.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: Chase Cannon, MD, MPH — University of Washington
- Study coordinator: Chase Cannon, MD, MPH
- Email: ccannon5@uw.edu
- Phone: 206-744-4393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HIV Prevention, Pre-exposure Prophylaxis, STI, Implementation science, PrEP, Screening, Telehealth