Cooperative Re-Engagement Controlled Trial (CoRECT)

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Cooperative Re-Engagement Controlled Trial (CoRECT)

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Other: Anti-Retroviral Treatment and Access to Services (ARTAS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Deceased Out of jurisdiction Changed providers Incarcerated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard of care (SOC) arm<br>Individuals found to be out of HIV medical care will receive standard of care to re-engage. This will not include use of disease intervention specialist to locate and recruit back to HIV medical care or use of the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention. | |
| Experimental: Intervention arm<br>Individuals randomized to the intervention arm will receive field services to locate, contact, and provide assistance to access HIV medical care. Intervention may include use of disease intervention specialist to locate and recruit back to HIV medical care or use of the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention. | Other: Anti-Retroviral Treatment and Access to Services (ARTAS)<br>* Anti-Retroviral Treatment and Access to Services (ARTAS) is an individual-level, multi-session, time-limited intervention with the goal of linking recently diagnosed persons with HIV to medical care soon after receiving their positive test result. ARTAS is based on the Strengths-based Case Management (SBCM) model, which is rooted in Social Cognitive Theory (particularly self-efficacy) and Humanistic Psychology. SBCM is a model that encourages the client to identify and use personal strengths; create goals for himself/herself; and establish an effective, working relationship with the Linkage Coordinator (LC).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attend one clinic visit | Patient will attend one clinical visit at CoRECT clinic to receive HIV medical care | within 90 days of randomization | 
| Remain engaged in care | Two or more medical visits at least 3 months apart within 12 months to demonstrate patient remains engaged in HIV medical care | defined as 2 clinic visits at least 3 months apart within 12 months | 
| Viral load suppression | Does the patient achieve viral load suppression within 12 months of randomization | within 12 months | 
| Achieve durable viral load suppression | Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months | defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, re-engagement in care, data to care