Oregon PrEP at Home Study

Oregon Health and Science University125 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

HIV/AIDS

Interventions

Cabotegravir InjectionDRUG

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

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

On-time initiation and continuation doses

Proportion of on-time initiation and continuation doses of CAB-LA administered

Time frame: 24 months

Secondary Outcomes

Successful home infusion pharmacy referrals

Proportion of referrals to home infusion that result in successful CAB-LA initiation over the study period

Time frame: 24 months

Time to initiation

Time in days between first tele-PrEP appointment and administration of first CAB-LA dose

Time frame: 24 months

Persistence rate

The persistence rate of participation in the tele-PrEP/home infusion pharmacy program for administration of CAB-LA

Time frame: 24 months

Sexually transmitted infection screenings

Number of HIV, gonorrhea, chlamydia, and syphilis screenings per participant over 10 months of CAB-LA continuation

Time frame: 24 months

Participant experience

Assessment of TPP/HIP program for delivery of CAB-LA continuation therapy using a bespoke questionnaire.

Time frame: 24 months

Oregon PrEP at Home Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts