Oregon PrEP at Home Study

HIV/AIDS Clinical Trial

— OR-PrEP@Home  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949203
• Other study ID #: STUDY00025207
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2023
• Source: Oregon Health and Science University
• Contact: Christopher B Fox, MSN
• Phone: 833-770-1400
• Email: prepstudy[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	ViiV Healthcare

Country where clinical trial is conducted

United States, 

Outcome

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