Cooperative Re-Engagement Controlled Trial (CoRECT)
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Other: Anti-Retroviral Treatment and Access to Services (ARTAS)
- Registration Number
- NCT02693145
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
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
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:
1. Attend 1 clinic visit within 90 days;
2. Remain engaged in care, defined as 2 clinic visits at least 3 months apart within 12 months;
3. Achieve viral load suppression within 12 months;
4. Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1893
-
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.
- Deceased
- Out of jurisdiction
- Changed providers
- Incarcerated
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm Anti-Retroviral Treatment and Access to Services (ARTAS) 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.
- Primary Outcome Measures
Name Time Method Achieve durable viral load suppression 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 within 90 days of randomization Patient will attend one clinical visit at CoRECT clinic to receive HIV medical care
Remain engaged in care 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 within 12 months Does the patient achieve viral load suppression within 12 months of randomization
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Connecticut Department of Public Health
🇺🇸Hartford, Connecticut, United States
Massachusetts Department of Public Health
🇺🇸Boston, Massachusetts, United States
Philadelphia Department of Health
🇺🇸Philadelphia, Pennsylvania, United States