Cooperative Re-Engagement Controlled Trial (CoRECT)

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

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