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

HIV Prevention Clinical Trial

— HOT4PrEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856942
• Other study ID #: STUDY00013871
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: September 8, 2025

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Chase Cannon, MD, MPH
• Phone: 206-744-4393
• Email: ccannon5[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 458
• Est. completion date: September 8, 2025
• Est. primary completion date: March 8, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Prevention
• Pre-exposure Prophylaxis
• STI

Intervention

Other:
• Health service - home-based PrEP monitoring
Home-based PrEP care

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Tasso Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP retention	Proportion of participants who successfully complete triannual monitoring tests and visits to receive a renewed PrEP prescription	18 months
Secondary	Reach	Proportion of patients who successfully utilize home-based monitoring for at least 50% of triannual visits over the study period	18 months
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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