Cooperative Re-Engagement Controlled Trial (CoRECT)

Human Immunodeficiency Virus Clinical Trial

— CoRECT  

Official title:

Cooperative Re-Engagement Controlled Trial (CoRECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693145
• Other study ID #: FOA PS14-001
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2020

Study information

• Verified date: February 2021
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1893
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts Department of Public Health	Boston	Massachusetts
United States	Connecticut Department of Public Health	Hartford	Connecticut
United States	Philadelphia Department of Health	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Connecticut State, Department of Mental Health and Addiction Services, Massachusetts Department of Health, Philadelphia Department of Public Health

Country where clinical trial is conducted

United States, 

References & Publications (9)

Bradley H, Hall HI, Wolitski RJ, Van Handel MM, Stone AE, LaFlam M, Skarbinski J, Higa DH, Prejean J, Frazier EL, Patel R, Huang P, An Q, Song R, Tang T, Valleroy LA. Vital Signs: HIV diagnosis, care, and treatment among persons living with HIV--United States, 2011. MMWR Morb Mortal Wkly Rep. 2014 Nov 28;63(47):1113-7. — View Citation

Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR; HPTN 052 Study Team. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18. — View Citation

Dombrowski JC. Testing, Linkage and Retention in Care: Getting Control of the Cascade in Seattle. National Summit on HIV and Viral Hepatitis Diagnosis, Prevention, and Access to Care, Washington, DC, November 26-8, 2012.

Gardner LI, Giordano TP, Marks G, Wilson TE, Craw JA, Drainoni ML, Keruly JC, Rodriguez AE, Malitz F, Moore RD, Bradley-Springer LA, Holman S, Rose CE, Girde S, Sullivan M, Metsch LR, Saag M, Mugavero MJ; Retention in Care Study Group. Enhanced personal contact with HIV patients improves retention in primary care: a randomized trial in 6 US HIV clinics. Clin Infect Dis. 2014 Sep 1;59(5):725-34. doi: 10.1093/cid/ciu357. Epub 2014 May 15. — View Citation

Gardner LI, Marks G, Craw JA, Wilson TE, Drainoni ML, Moore RD, Mugavero MJ, Rodriguez AE, Bradley-Springer LA, Holman S, Keruly JC, Sullivan M, Skolnik PR, Malitz F, Metsch LR, Raper JL, Giordano TP; Retention in Care Study Group. A low-effort, clinic-wide intervention improves attendance for HIV primary care. Clin Infect Dis. 2012 Oct;55(8):1124-34. Epub 2012 Jul 24. — View Citation

Gardner LI, Metsch LR, Anderson-Mahoney P, Loughlin AM, del Rio C, Strathdee S, Sansom SL, Siegal HA, Greenberg AE, Holmberg SD; Antiretroviral Treatment and Access Study Study Group. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS. 2005 Mar 4;19(4):423-31. — View Citation

Skarbinski J, Rosenberg E, Paz-Bailey G, Hall HI, Rose CE, Viall AH, Fagan JL, Lansky A, Mermin JH. Human immunodeficiency virus transmission at each step of the care continuum in the United States. JAMA Intern Med. 2015 Apr;175(4):588-96. doi: 10.1001/jamainternmed.2014.8180. — View Citation

The White House Office of National AIDS Policy. National HIV/AIDS Strategy. Available at: http://www.whitehouse.gov/administration/eop/onap/nhas. Accessed: 30 January 2015.

Udeagu CC, Webster TR, Bocour A, Michel P, Shepard CW. Lost or just not following up: public health effort to re-engage HIV-infected persons lost to follow-up into HIV medical care. AIDS. 2013 Sep 10;27(14):2271-9. doi: 10.1097/QAD.0b013e328362fdde. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attend one clinic visit	Patient will attend one clinical visit at CoRECT clinic to receive HIV medical care	within 90 days of randomization
Primary	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
Primary	Viral load suppression	Does the patient achieve viral load suppression within 12 months of randomization	within 12 months
Primary	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