HIV/AIDSOR-PrEP@HomeNCT05949203
Oregon PrEP at Home Study
An observational study of HIV/AIDS, run by Oregon Health and Science University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Cabotegravir Injection
- Type of treatment
- Injection or infusion
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Oregon age 18 or older who are eligible for HIV pre-exposure prophylaxis with long-acting cabotegravir through the OHSU Tele-PrEP Program and OHSU Home Infusion Pharmacy. People of childbearing potential or who are breast/chest feeding are eligible, but pregnant people are ineligible.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Christopher B Fox, MSN, 833-770-1400, prepstudy@ohsu.edu
Christopher D Evans, MD, MPH
About this study
Official title: 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
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
- Being tested
- Cabotegravir Injection
- Keywords
- HIV prevention, PrEP, telemedicine, home infusion pharmacy, long-acting cabotegravir
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir InjectionDrug
Also called Apretude
Administration of HIV pre-exposure prophylaxis with cabotegravir 600 mg/3mL extended release injectable suspension every other month.
| Study group | Role | What they receive |
|---|---|---|
| All participants | All participants will receive standard-of-care through the tele-PrEP program and home infusion pharmacy. Receives: Drug: Cabotegravir Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
On-time initiation and continuation doses
Proportion of on-time initiation and continuation doses of CAB-LA administered
Measured: 24 months
Secondary outcomes (5)
Successful home infusion pharmacy referrals
Proportion of referrals to home infusion that result in successful CAB-LA initiation over the study period
Measured: 24 months
Time to initiation
Time in days between first tele-PrEP appointment and administration of first CAB-LA dose
Measured: 24 months
Persistence rate
The persistence rate of participation in the tele-PrEP/home infusion pharmacy program for administration of CAB-LA
Measured: 24 months
Sexually transmitted infection screenings
Number of HIV, gonorrhea, chlamydia, and syphilis screenings per participant over 10 months of CAB-LA continuation
Measured: 24 months
Participant experience
Assessment of TPP/HIP program for delivery of CAB-LA continuation therapy using a bespoke questionnaire.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor
- Investigators
- Christopher B Fox, MSN, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949203
- Sponsor's protocol ID
- STUDY00025207
- Acronym
- OR-PrEP@Home
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data and adverse event reporting will be shared with the study partner ViiV Healthcare.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05949203
- Acronym / sponsor ID
- OR-PrEP@Home / STUDY00025207
- Conditions
- HIV/AIDS
- Keywords
- HIV prevention, PrEP, telemedicine, home infusion pharmacy, long-acting cabotegravir
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Drug: Cabotegravir InjectionAll participants will receive standard-of-care through the tele-PrEP program and home infusion pharmacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Oregon age 18 or older who are eligible for HIV pre-exposure prophylaxis with long-acting cabotegravir through the OHSU Tele-PrEP Program and OHSU Home Infusion Pharmacy. People of childbearing potential or who are breast/chest feeding are eligible, but pregnant people are ineligible.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir InjectionAlso: ApretudeAdministration of HIV pre-exposure prophylaxis with cabotegravir 600 mg/3mL extended release injectable suspension every other month. | Drug | All participants |
Primary outcome
On-time initiation and continuation doses
Time frame: 24 months
Proportion of on-time initiation and continuation doses of CAB-LA administered
5 secondary outcomes
Successful home infusion pharmacy referrals
Time frame: 24 months
Time to initiation
Time frame: 24 months
Persistence rate
Time frame: 24 months
Sexually transmitted infection screenings
Time frame: 24 months
Participant experience
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data and adverse event reporting will be shared with the study partner ViiV Healthcare.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher B Fox, MSN principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher B Fox, MSN (833-770-1400, prepstudy@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
On-time initiation and continuation doses (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.