An interventional study of Health service - home-based PrEP monitoring in HIV Prevention, Pre-exposure Prophylaxis and STI, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by University of Washington · Not applicable, Interventional, and Health services research
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:
Pre-exposure prophylaxis (PrEP) is an established and effective method for HIV prevention, but lack of access to PrEP providers and the burden of quarterly monitoring visits remain barriers to PrEP uptake and retention, particularly for people of color and younger men who have sex with men (MSM). Home-based PrEP (HB-PrEP) monitoring could unburden medical systems and increase PrEP access, but whether this remote care option improves key clinical outcomes like PrEP retention is not known.
The study's specific aims are to:
The Aim 1 study is a pragmatic, non-blinded, hybrid type 1 (clinical-implementation) RCT and includes mixed-methods assessments to evaluate both qualitative and quantitative data for the primary and secondary outcomes. Aim 3 is a qualitative study using in-depth interviews.
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Other: Health service - home-based PrEP monitoring
Home-based PrEP care
PrEP retention
Proportion of participants who successfully complete triannual monitoring tests and visits to receive a renewed PrEP prescription
Time frame: 18 months
Reach
Proportion of patients who successfully utilize home-based monitoring for at least 50% of triannual visits over the study period
Time frame: 18 months
User satisfaction
Self-reported satisfaction with the assigned PrEP care strategy on Likert scale (1: very satisfied to 5: very dissatisfied)
Time frame: Every 4 months up to 16 months and at study exit (on/after 18 months)
PrEP adherence
Self-reported adherence within prior 4 weeks to self-selected PrEP use strategy (daily vs event-driven PrEP); ordinal self-reported adherence scale from excellent to very poor
Time frame: Every 4 months up to 16 months and at study exit (on/after 18 months)
Time to action on abnormal results
Time from receipt and review of abnormal monitoring or HIV/STI results to patient notification
Time frame: Every 4 months up to 16 months and at study exit (on/after 18 months)
STI positivity rate
Composite asymptomatic STI (syphilis, gonorrhea, chlamydia) rate
Time frame: Every 4 months up to 16 months and at study exit (on/after 18 months)
Barriers and facilitators of PrEP retention
In-depth interviews with study participants and clinic staff/administrators to understand B\&F of PrEP retention
Time frame: Every 4 months starting at month 4 until target of 24 reached
Cost
"Real world" costs of PrEP delivery and retention in each arm (total dollars spent per individual retained on PrEP per month)
Time frame: Month 12 through study completion, an average of 6 months
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