Oregon PrEP at Home Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Drug: Cabotegravir Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-time initiation and continuation doses | Proportion of on-time initiation and continuation doses of CAB-LA administered | 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, PrEP, telemedicine, home infusion pharmacy, long-acting cabotegravir