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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- On-time initiation and continuation doses
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
All participants
All participants will receive standard-of-care through the tele-PrEP program and home infusion pharmacy.
干预措施: Cabotegravir Injection (Drug)
结局指标
主要结局
On-time initiation and continuation doses
时间窗: 24 months
Proportion of on-time initiation and continuation doses of CAB-LA administered
次要结局
- Time to initiation(24 months)
- Sexually transmitted infection screenings(24 months)
- Successful home infusion pharmacy referrals(24 months)
- Participant experience(24 months)
- Persistence rate(24 months)