Clinical trial NCT05949203: Oregon PrEP at Home Study
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV/AIDS
Keywords: HIV prevention
PrEP
telemedicine
home infusion pharmacy
long-acting cabotegravir
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2023-07-17
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: On-time initiation and continuation doses
timeFrame: 24 months
Secondary outcomes:
measure: Successful home infusion pharmacy referrals
timeFrame: 24 months
measure: Time to initiation
timeFrame: 24 months
measure: Persistence rate
timeFrame: 24 months
measure: Sexually transmitted infection screenings
timeFrame: 24 months
measure: Participant experience
timeFrame: 24 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Christopher B Fox, MSN
role: PRINCIPAL_INVESTIGATOR
References: