Recruiting

HIV Pre-exposure Prophylaxis

Sponsor:

University of Washington

Code:

NCT05856942

Conditions

HIV Prevention

Pre-exposure Prophylaxis

STI

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Health service - home-based PrEP monitoring

Study Details

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.

Conditions

HIV Prevention

Pre-exposure Prophylaxis

STI

Study ID

NCT05856942

Start date

Mar 8, 2022

Status verified date

May, 2024

Completion date

Sep 8, 2025

Anticipated

Primary completion date

Mar 8, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

458 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Standard care

Patients will receive standard PrEP care in the clinic including in-person visits for triannual (every 4 months) HIV \& STI screening and comprehensive sexual health care.

experimental: Home-based care

Patients will have the option to complete their PrEP care from home including 1) self-collection of blood specimens for HIV, syphilis and creatinine; 2) self-swabs for extragenital GC/CT screening; and 3) telehealth follow-up. A maximum of two triannual follow-up visits per year may be conducted remotely; one visit per year must be in person. Participants also have the option to attend visits in person and are otherwise eligible to continue receiving comprehensive sexual health services in the clinic.

Interventions

Health service - home-based PrEP monitoring

Home-based PrEP care

Primary outcome measure

  • PrEP retention [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Chase Cannon, MD, MPH

206-744-4393ccannon5@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

University of Washington

Last update posted

May 10, 2024

Last verified

May, 2024

Keywords

  • Implementation science
  • PrEP
  • Screening
  • Telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-05-10.