HIV/AIDS
Conditions
Keywords
HIV prevention, PrEP, telemedicine, home infusion pharmacy, long-acting cabotegravir
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.
Interventions
Administration of HIV pre-exposure prophylaxis with cabotegravir 600 mg/3mL extended release injectable suspension every other month.
Sponsors
ViiV Healthcare
Oregon Health and Science University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| On-time initiation and continuation doses | 24 months | Proportion of on-time initiation and continuation doses of CAB-LA administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful home infusion pharmacy referrals | 24 months | Proportion of referrals to home infusion that result in successful CAB-LA initiation over the study period |
| Time to initiation | 24 months | Time in days between first tele-PrEP appointment and administration of first CAB-LA dose |
| Persistence rate | 24 months | The persistence rate of participation in the tele-PrEP/home infusion pharmacy program for administration of CAB-LA |
| Sexually transmitted infection screenings | 24 months | Number of HIV, gonorrhea, chlamydia, and syphilis screenings per participant over 10 months of CAB-LA continuation |
| Participant experience | 24 months | Assessment of TPP/HIP program for delivery of CAB-LA continuation therapy using a bespoke questionnaire. |
Countries
United States
Contacts
Primary ContactChristopher B Fox, MSN
Outcome results
None listed