Hybrid Evaluation of a Home-based HIV Pre-exposure Prophylaxis Program

Study Overview
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Brief Summary
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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: 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. 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. Develop a qualitative tool to engage healthcare stakeholders and determine the wider scalability of HB-PrEP.

Detailed Description
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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.

Official Title
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Hybrid Evaluation of the Implementation and Effectiveness of Home-based HIV Pre-exposure Prophylaxis Monitoring in King County, Washington

Conditions
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STI, HIV Prevention, Pre-exposure Prophylaxis

Intervention / Treatment
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* Other: Health service - home-based PrEP monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>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<br>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<br>* Home-based PrEP care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP retention | Proportion of participants who successfully complete triannual monitoring tests and visits to receive a renewed PrEP prescription | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach | Proportion of patients who successfully utilize home-based monitoring for at least 50% of triannual visits over the study period | 18 months | 
| User satisfaction | Self-reported satisfaction with the assigned PrEP care strategy on Likert scale (1: very satisfied to 5: very dissatisfied) | 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 | 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 | 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 | 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 | 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) | Month 12 through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, Implementation science, Screening, Telehealth