Cooperative Re-Engagement Controlled Trial (CoRECT)

Centers for Disease Control and Prevention (CDC)

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Other: Anti-Retroviral Treatment and Access to Services (ARTAS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02693145

FOA PS14-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,893 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. 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

1. Deceased
2. Out of jurisdiction
3. Changed providers
4. Incarcerated

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,893 participants in 2 patient groups

standard of care (SOC) arm

No Intervention group

Description:

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.

Intervention arm

Experimental group

Description:

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.

Treatment:

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