跳至主要内容
临床试验/NCT04863261
NCT04863261已完成不适用

Facilitating the Management of CAB+RPV LA Patient Visits Through Daily Alerts and Morning Huddles

Epividian2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Epividian
入组人数
37
试验地点
2
主要终点
Acceptability and usefulness of the intervention

研究概览

简要总结

This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. The purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of HIV.

详细描述

A novel long-acting HIV antiretroviral therapy has recently been approved by the FDA: cabotegravir and rilpivirine delivered through intramuscular injection. These injections should be administered monthly, on the same day of the month as the initiation injections, up to 7 days before or after the date of the scheduled monthly injection visit.

This is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. Providers in the intervention group will receive alerts to remind them when patients are due for their injections, or if they missed their treatment window. Providers in the control group will not receive alerts and will manage injections as per their clinic's standard process. Surveys will be administered to understand the utility of the alerts for the management of these injections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • (patients):
  • As per label, routine clinical care
  • Inclusion Criteria (clinics):
  • AIDS Healthcare Foundation (AHF) Clinic
  • HIV primary care clinic
  • Minimum of 100 people living with HIV in care with a viral load <50 copies/mL at the time of randomization (satellites will be included in the count of their parent clinic).

排除标准

  • 未提供

结局指标

主要结局

Acceptability and usefulness of the intervention

时间窗: Month 9

Survey to assess the implementation of the Cabenuva Scheduling Alerts in the Retention \& Huddle modules of the CHORUS App.

Adherence to treatment-window

时间窗: 9 months

Patient returns for their injections +/- 7 days from target date

次要结局

  • Number of CAB+RPV LA patients managed through the app(9 months)
  • Number of clinics that use the App for the management of CAB+RPV LA patients(9 month)

研究者

发起方
Epividian
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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