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

NCT05856942 | Recruiting

• 1 other identifier: STUDY00013871
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Develop a qualitative tool to engage healthcare stakeholders and determine the wider scalability of HB-PrEP.

Conditions

HIV Prevention; Pre-exposure Prophylaxis; STI

Keywords

Implementation science; PrEP; Screening; Telehealth

Outcome Measures

Primary Outcomes (1)

• PrEP retention

  Proportion of participants who successfully complete triannual monitoring tests and visits to receive a renewed PrEP prescription

  18 months

Secondary Outcomes (7)

• Reach

  18 months

• User satisfaction

  Every 4 months up to 16 months and at study exit (on/after 18 months)

• PrEP adherence

  Every 4 months up to 16 months and at study exit (on/after 18 months)

• Time to action on abnormal results

  Every 4 months up to 16 months and at study exit (on/after 18 months)

• STI positivity rate

  Every 4 months up to 16 months and at study exit (on/after 18 months)

Study Arms (2)

Standard care

NO INTERVENTION

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.

Home-based care

EXPERIMENTAL

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

Interventions

Health service - home-based PrEP monitoring OTHER

Home-based PrEP care

Home-based care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Tasso Inc.: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 35562692 BACKGROUND

• Cannon C, Holzhauer K, Golden M. Implementation and Evaluation of a Home-Based Pre-Exposure Prophylaxis Monitoring Option: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 23;13:e56587. doi: 10.2196/56587.

  PMID: 39312771 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chase Cannon, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chase Cannon, MD, MPH

CONTACT

206-744-4393; ccannon5@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 12, 2023
• Study Start: March 8, 2022
• Primary Completion: March 8, 2025
• Study Completion: September 8, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

US (1)