Oregon PrEP at Home Study

NCT05949203 | Unknown FDA Drug

• 1 other identifier: STUDY00025207
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS

Keywords

HIV prevention; PrEP; telemedicine; home infusion pharmacy; long-acting cabotegravir

Outcome Measures

Primary Outcomes (1)

• On-time initiation and continuation doses

  Proportion of on-time initiation and continuation doses of CAB-LA administered

  24 months

Secondary Outcomes (5)

• Successful home infusion pharmacy referrals

  24 months

• Time to initiation

  24 months

• Persistence rate

  24 months

• Sexually transmitted infection screenings

  24 months

• Participant experience

  24 months

Study Arms (1)

All participants

All participants will receive standard-of-care through the tele-PrEP program and home infusion pharmacy.

Drug: Cabotegravir Injection

Interventions

Cabotegravir Injection DRUG

Administration of HIV pre-exposure prophylaxis with cabotegravir 600 mg/3mL extended release injectable suspension every other month.

Also known as: Apretude

All participants

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All genders are eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Christopher B Fox, MSN

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher B Fox, MSN

CONTACT

833-770-1400; prepstudy@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 17, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)