OR-PrEP@Home: Oregon PrEP at Home Study

Sponsor

Oregon Health and Science University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05949203

Collaborator

ViiV Healthcare (Industry)

125

Enrollment

Location

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS	Drug: Cabotegravir Injection

Study Design

Study Type:

Observational

Anticipated Enrollment :

125 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
All participants All participants will receive standard-of-care through the tele-PrEP program and home infusion pharmacy.	Drug: Cabotegravir Injection Administration of HIV pre-exposure prophylaxis with cabotegravir 600 mg/3mL extended release injectable suspension every other month. Other Names: Apretude

Arm

Intervention/Treatment

All participants

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

Drug: Cabotegravir Injection

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

Other Names:

Apretude

Outcome Measures

Primary Outcome Measures

On-time initiation and continuation doses [24 months]
Proportion of on-time initiation and continuation doses of CAB-LA administered

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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