Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | All participants will receive standard-of-care through the tele-PrEP program and home infusion pharmacy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabotegravir Injection | Drug | Administration of HIV pre-exposure prophylaxis with cabotegravir 600 mg/3mL extended release injectable suspension every other month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| On-time initiation and continuation doses | Proportion of on-time initiation and continuation doses of CAB-LA administered | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Successful home infusion pharmacy referrals | Proportion of referrals to home infusion that result in successful CAB-LA initiation over the study period | 24 months |
| Time to initiation | Time in days between first tele-PrEP appointment and administration of first CAB-LA dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
All genders are eligible
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher B Fox, MSN | Contact | 833-770-1400 | prepstudy@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher B Fox, MSN | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
De-identified individual participant data and adverse event reporting will be shared with the study partner ViiV Healthcare.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C584914 | cabotegravir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 24 months |
| Persistence rate | The persistence rate of participation in the tele-PrEP/home infusion pharmacy program for administration of CAB-LA | 24 months |
| Sexually transmitted infection screenings | Number of HIV, gonorrhea, chlamydia, and syphilis screenings per participant over 10 months of CAB-LA continuation | 24 months |
| Participant experience | Assessment of TPP/HIP program for delivery of CAB-LA continuation therapy using a bespoke questionnaire. | 24 months |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |