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

Oregon Health & Science University (OHSU)

Status

Enrolling

Conditions

HIV/AIDS

Treatments

Drug: Cabotegravir Injection

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05949203

STUDY00025207

Details and patient eligibility

About

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.

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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