Oregon PrEP at Home Study

Recruiting

• Conditions: HIV/AIDS
• Interventions: Drug: Cabotegravir Injection

• Registration Number: NCT05949203
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-07-15
• Study First Posted: 2023-07-17
• Study Start: 2023-12-01
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Cabotegravir Injection	All participants will receive standard-of-care through the tele-PrEP program and home infusion pharmacy.

Primary Outcome Measures

Name	Time	Method
On-time initiation and continuation doses	24 months	Proportion of on-time initiation and continuation doses of CAB-LA administered

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States