Oregon PrEP at Home Study (OR-PrEP@Home)

Oregon PrEP at Home Study: Real-world Delivery of Long-acting Cabotegravir (CAB-LA) for HIV Pre-exposure Prophylaxis (PrEP) Through a Tele-PrEP Program and a Home Infusion Program Partnership to Address Geographic PrEP Disparities in Oregon

This demonstration study will evaluate the real-world implementation of long-acting cabotegravir (CAB-LA) for HIV pre-exposure prevention (PrEP) through a partnership between the OHSU Tele-PrEP Program (TPP) and the OHSU Home Infusion Pharmacy (HIP). The study will perform a formative evaluation of the TPP/HIP partnership to determine its merit and worth, with revisions made as needed to improve the program, which is reflective of a real-world program rollout. The study is observational, and there is no comparison group. The primary objective is to evaluate adherence to CAB-LA by both urban and rural participants using the TPP/HIP partnership. The goals of the study are improve the TPP/HIP program itself with attention to reducing geographic disparities, and to disseminate best practices and lessons learned to the broader HIV prevention community.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Drug: Cabotegravir Injection

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Christopher B Fox, MSN; Phone Number: 833-770-1400; Email: prepstudy@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Christopher B Fox, MSN; Phone Number: 833-770-1400; Email: prepstudy@ohsu.edu
      • Sub-Investigator: Christopher D Evans, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Residents of Oregon age 18 or older who are eligible for HIV pre-exposure prophylaxis with long-acting cabotegravir through the OHSU Tele-PrEP Program and OHSU Home Infusion Pharmacy. People of childbearing potential or who are breast/chest feeding are eligible, but pregnant people are ineligible.

Description

Inclusion Criteria:

• Residence in Oregon
• English or Spanish spoken and written language ability
• Clinical eligibility for PrEP with CAB-LA including HIV-negative serostatus
• Access to stable Internet
• Access to a clean, safe location that is appropriate for home administration

Exclusion Criteria:

• Clinical ineligibility for PrEP with CAB-LA including HIV-positive serostatus, injection drug use as only HIV risk factor, or clinical contraindication (such as a hypersensitivity reaction to CAB-LA or use of a contraindicated medication).
• Uninsured
• Payer does not cover HIP services
• Pregnancy
• Residence outside of the home infusion program's catchment area
• Incarceration
• Decisional impairment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; All participants will receive standard-of-care through the tele-PrEP program and home infusion pharmacy.	Drug: Cabotegravir Injection; Administration of HIV pre-exposure prophylaxis with cabotegravir 600 mg/3mL extended release injectable suspension every other month.; Other Names: Apretude

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
On-time initiation and continuation doses	Proportion of on-time initiation and continuation doses of CAB-LA administered	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful home infusion pharmacy referrals	Proportion of referrals to home infusion that result in successful CAB-LA initiation over the study period	24 months
Time to initiation	Time in days between first tele-PrEP appointment and administration of first CAB-LA dose	24 months
Persistence rate	The persistence rate of participation in the tele-PrEP/home infusion pharmacy program for administration of CAB-LA	24 months
Sexually transmitted infection screenings	Number of HIV, gonorrhea, chlamydia, and syphilis screenings per participant over 10 months of CAB-LA continuation	24 months
Participant experience	Assessment of TPP/HIP program for delivery of CAB-LA continuation therapy using a bespoke questionnaire.	24 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: ViiV Healthcare
• Investigators: Principal Investigator: Christopher B Fox, MSN, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 15, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: PrEP; telemedicine; HIV prevention; home infusion pharmacy; long-acting cabotegravir
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Cabotegravir
• Other Study ID Numbers: STUDY00025207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data and adverse event reporting will be shared with the study partner ViiV Healthcare.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No