Recruiting

PrEP

Sponsor:

Oregon Health and Science University

Code:

NCT05949203

Conditions

HIV/AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cabotegravir Injection

Study Details

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.

Conditions

HIV/AIDS

Study ID

NCT05949203

Start date

Dec 1, 2023

Status verified date

Jun, 2023

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

All participants

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

Interventions

Cabotegravir Injection

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

Primary outcome measure

  • On-time initiation and continuation doses [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Christopher B Fox, MSN

833-770-1400prepstudy@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Christopher B Fox, MSN

833-770-1400prepstudy@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Dec 6, 2023

Last verified

Jun, 2023

Keywords

  • HIV prevention
  • PrEP
  • telemedicine
  • home infusion pharmacy
  • long-acting cabotegravir

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2023-12-06.