Clinical trial NCT05856942: Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program
Official title: Hybrid Evaluation of the Implementation and Effectiveness of Home-based HIV Pre-exposure Prophylaxis Monitoring in King County, Washington
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Pre-exposure Prophylaxis
STI
Keywords: Implementation science
PrEP
Screening
Telehealth
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Tasso Inc.
First posted: 2023-05-12
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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:

* AIM 1: Evaluate the impact of HB-PrEP on PrEP retention and define the factors that influence HB-PrEP implementation. The investigators will conduct a type 1 hybrid randomized controlled trial comparing HB-PrEP as an implementation strategy (self-collected lab specimens from home and telehealth follow-up) to standard of care (SOC) at the Public Health-Seattle \& King County (PHSKC) Sexual Health Clinic (SHC). The study's primary outcome will be effectiveness of the implementation strategy measured as the rate of retention in PrEP care. In secondary analyses, investigators will utilize mixed methods to assess reach (proportion of persons offered HB-PrEP who choose to use it), and examine individual-level barriers and facilitators (B\&F) to PrEP retention (participant surveys and interviews) and system-level B\&F to HB-PrEP implementation (participant surveys and interviews, PHSKC staff interviews). 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.
* AIM 2: Perform a cost analysis of HB-PrEP service implementation at the PHSKC SHC compared to SOC. Investigators will track resource use and prospectively collect unit costs for laboratory fees, healthcare worker time and other clinic resources to estimate the total monthly cost of providing HB-PrEP services overall and the monthly cost per person retained in PrEP care in the HB-PrEP and SOC arms. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC.
* AIM 3: Conduct a HB-PrEP scale-up assessment with healthcare organizations (HCO) and other key stakeholders to determine the scalability of HB-PrEP within Washington State. To evaluate institution-level factors that may impede or facilitate statewide HB-PrEP scale-up, investigators will conduct semi-structured interviews with key stakeholders from a countywide EHE HCO collaborative.

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.

Eligibility 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

Primary outcomes:
measure: PrEP retention
timeFrame: 18 months
Secondary outcomes:
measure: Reach
timeFrame: 18 months
measure: User satisfaction
timeFrame: Every 4 months up to 16 months and at study exit (on/after 18 months)
measure: PrEP adherence
timeFrame: Every 4 months up to 16 months and at study exit (on/after 18 months)
measure: Time to action on abnormal results
timeFrame: Every 4 months up to 16 months and at study exit (on/after 18 months)
measure: STI positivity rate
timeFrame: Every 4 months up to 16 months and at study exit (on/after 18 months)
measure: Barriers and facilitators of PrEP retention
timeFrame: Every 4 months starting at month 4 until target of 24 reached
measure: Cost
timeFrame: Month 12 through study completion, an average of 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Chase Cannon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cannon CA, Ramchandani MS, Golden MR. Feasibility of a novel self-collection method for blood samples and its acceptability for future home-based PrEP monitoring. BMC Infect Dis. 2022 May 13;22(1):459. doi: 10.1186/s12879-022-07432-0.