Developing a Novel Delivery System for CAB-RPV LA in Transgender Women Living With HIV in Public Health Settings
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of delivering CAB-RPV LA
研究概览
简要总结
This is a single-arm implementation study of a novel integrated delivery model of CAB-RPV LA for transwomen living with HIV.
详细描述
CAB-RPV LA as a monthly injectable could address disparities in viral suppression among trans women living with HIV. This study is designed to enroll a diverse population of trans women living with HIV who receive HIV care within collaborating primary care clinics. This study proposes using mixed methods to tailor and evaluate implementation and client outcomes when CAB-RPV LA is delivered through this integrated delivery model.
This will be a 9-month pilot study among 40 participants who will be provided CAB-RPV LA through an integrated trans-friendly delivery model using 4 implementation strategies to improve the adoption and integration of CAB-RPV LA delivery to trans women. These strategies are aimed at all levels of implementation - system, clinic, provider, and patient to maximize impact. The 4 strategies are a patient-centered injection site (Bridge HIV, SFDPH), patient-centered adherence support (peer health navigation and SMS platform with reminders and communication with staff), provider education, and improved clinic communication strategies.. CAB-RPV LA is being provided as standard of care and is not paid for by the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Male sex at birth and gender identity other than male
- •Willing and able to provide written informed consent
- •HIV-infected, confirmed by laboratory testing (can be via medical record)
- •Eligible to receive CAB-RPV LA per FDA-approved label
- •Virologically suppressed at the last visit within the last 6 months (HIV RNA <50 copies/ml)
- •Interested in initiating CAB-RPV LA for HIV treatment and willing to receive injections at Bridge HIV
- •Currently receiving HIV care by a care provider at one of the collaborating primary care clinics.
- •Has a cell phone and active service
- •Able to understand, read, and speak English
排除标准
- •Unable to receive gluteal injections
- •Plans to move away from the site area within the next 9 months.
- •History of known or suspected drug resistance that would compromise the CAB-RPV regimen
- •Rilpivirine: L100I; K101E; V106I and A; V108I; E138K and A, G, Q, R; V179F and I; Y181C and I; V189I; G190E; H221Y and H/L; F227C; and M230I and L; K103N+K238T, K103N+E138G+K238T; Y188L
- •Cabotegravir: Q146L; S153Y; I162M; T124A; Q148H, K; C56S; V72I; L74M; V75A; T122N; E138K; G140S; G149A; M154I; and N155H
- •Prior hypersensitivity to cabotegravir or rilpivirine
- •Current or expected use of any of the following medications:
- •Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- •Antimycobacterials: rifabutin, rifampin, rifapentine
- •Systemic glucocorticoids: more than a single dose of dexamethasone
- •Herbal: St John's Wort
- •Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
结局指标
主要结局
Feasibility of delivering CAB-RPV LA
时间窗: 0, 9,18 Months
Assess the feasibility of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
Acceptability of delivering CAB-RPV LA
时间窗: 0, 9,18 Months
Assess the acceptability of delivering CAB-RPV LA to trans women living with HIV via a trans-tailored, integrated delivery model
Client Satisfaction
时间窗: 0, 3, 6, 9 Months
Assess client satisfaction with treatment when CAB-RPV LA is delivered through a trans-tailored integrated model
次要结局
- Assess adherence to injections(3, 6, 9 Months)
- Assess viral suppression(3, 6, 9 Months)
- Describe development of resistance mutations(3, 6, 9 Months)
- Assess tolerability(3, 6, 9 Months)
研究者
Albert Liu
Clinical Research Director
Public Health Foundation Enterprises, Inc.