Oregon PrEP at Home Study

Last updated: December 5, 2023
Sponsor: Oregon Health and Science University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv/aids

Aids And Aids Related Infections

Hiv Infections

Treatment

Cabotegravir Injection

Clinical Study ID

NCT05949203
STUDY00025207
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

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 ahypersensitivity 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

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: Cabotegravir Injection
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

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