Cooperative Re-Engagement Controlled Trial (CoRECT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,893
- 试验地点
- 6
- 主要终点
- Achieve durable viral load suppression
研究概览
简要总结
CoRECT will help identify the important components of a data-sharing partnership between health departments and HIV care providers, and determine the extent to which a health department intervention can increase the number of HIV-infected persons out-of-care who: (a) link to an HIV clinic; (b) remain in HIV medical care; (c) achieve HIV viral load suppression within 12 months; and (d) achieve durable HIV viral load suppression over 18 months. We will also measure the cost-effectiveness of this intervention in regards to improved health in the individuals (re)-engaged in HIV care and reductions in further HIV transmission in the community.
详细描述
Methods summary: Health departments will generate an out-of-care list using HIV laboratory surveillance data; collaborating clinics will concurrently generate out-of-care lists using appointment data. The combined out-of-care list will be reconciled by the health department and clinics, and discussed at monthly case conferences. All individuals determined to be out-of care will be randomized to receive either: (1) usual linkage and engagement in care services (standard of care [SOC]); or (2) an active health department field services intervention in addition to SOC. The active intervention activities will vary among jurisdictions; however all sites will include field services to locate, contact, and provide assistance, including a same-day appointment, to access HIV medical care.
Study design: Each site will enroll 600 out-of-care HIV-infected individuals (300 per arm) during a two-year enrollment period. An out-of-care individual will be defined as: (1) a person who has received HIV medical care at a CoRECT clinic and then disengages from care; or (2) a person with newly diagnosed HIV infection who has an appointment at a CoRECT clinic, but has not linked to medical care within 90 days.
Intervention: Individuals randomized to the intervention arm will receive field services to locate, contact, and provide assistance to access HIV medical care. Services provided as part of the intervention will vary by jurisdiction, but may include assistance with expedited medical appointments, transportation, access to community resources such as traditional case management, strengths-based case management, or financial incentives (Appendix A).
Primary outcomes: The following outcomes will be compared between out-of-care HIV-infected individuals receiving the study intervention to those receiving usual services:
- Attend 1 clinic visit within 90 days;
- Remain engaged in care, defined as 2 clinic visits at least 3 months apart within 12 months;
- Achieve viral load suppression within 12 months;
- Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents within the health department jurisdiction who have received HIV medical care at a CoRECT clinic and then disengage by either of the following definitions:
- •Clinic definition: did not have a visit with a prescribing provider for 6 months.
- •Health department definition: no CD4 or viral load test result reported to health department surveillance for more than 6 months.
- •Residents within the health department jurisdiction with newly diagnosed HIV infection who have not linked to medical care within 90 days and have either:
- •Received, but did not attend, an appointment at a CoRECT clinic; or
- •Attended an enrollment visit but did not receive medical care at a CoRECT clinic.
排除标准
- •Out of jurisdiction
- •Changed providers
- •Incarcerated
结局指标
主要结局
Achieve durable viral load suppression
时间窗: defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
Attend one clinic visit
时间窗: within 90 days of randomization
Patient will attend one clinical visit at CoRECT clinic to receive HIV medical care
Remain engaged in care
时间窗: defined as 2 clinic visits at least 3 months apart within 12 months
Two or more medical visits at least 3 months apart within 12 months to demonstrate patient remains engaged in HIV medical care
Viral load suppression
时间窗: within 12 months
Does the patient achieve viral load suppression within 12 months of randomization
次要结局
未报告次要终点