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NCT05856942 · ClinicalTrials.gov registry record · NA
Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
A NA study of HIV Prevention and Pre-exposure Prophylaxis, sponsored by University of Washington.
- Recruiting
- Registry status
- NA
- Development phase
- 458
- Enrollment target
- 1
- Study location
NCT05856942 is a NA study of HIV Prevention and Pre-exposure Prophylaxis that is actively recruiting participants, run by University of Washington. The registered enrollment target is 458 participants, above the 368-participant average among 32 other HIV Prevention trials with a reported enrollment target (24% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05856942, a NA study of HIV Prevention and Pre-exposure Prophylaxis, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- NA
- Development phase
- 458 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER Health service - home-based PrEP monitoring
Study Locations (1)
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2022-03-08 |
| Est. Completion | 2025-09-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05856942
The ClinicalTrials.gov registry entry for NCT05856942 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 458 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 368-participant average among 32 other HIV Prevention trials with a reported enrollment target (24% higher). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with HIV Prevention appearing as the primary indexed condition, and to 1 intervention - of which Health service - home-based PrEP monitoring is the first listed.
NCT05856942 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT05856942 about?
NCT05856942 is a clinical study titled "Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program". 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 b...
What is the current status of trial NCT05856942?
This trial is currently recruiting. It is a NA study. The enrollment target is 458 participants. The study started on 2022-03-08. Estimated completion is 2025-09-08.
What conditions does trial NCT05856942 study?
This clinical trial studies the following conditions: HIV Prevention, Pre-exposure Prophylaxis, STI.
What interventions are being tested in trial NCT05856942?
The interventions under investigation include: Health service - home-based PrEP monitoring (OTHER).
Who is sponsoring clinical trial NCT05856942?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05856942 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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