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Oregon PrEP at Home Study

NCT ID: NCT05949203

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-12-01

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.

Detailed Description

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Conditions

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HIV/AIDS

Keywords

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HIV prevention PrEP telemedicine home infusion pharmacy long-acting cabotegravir

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

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

Cabotegravir Injection

Intervention Type DRUG

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

Interventions

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Cabotegravir Injection

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

Intervention Type DRUG

Other Intervention Names

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Apretude

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher B Fox, MSN

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christopher B Fox, MSN

Role: CONTACT

Phone: 833-770-1400

Email: [email protected]

Facility Contacts

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Christopher B Fox, MSN

Role: primary

Other Identifiers

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STUDY00025207

Identifier Type: -

Identifier Source: org_study_id