Cooperative Re-Engagement Controlled Trial (CoRECT)

NCT02693145 | Completed

• 1 other identifier: FOA PS14-001
• Study Type: interventional
• Target: 1,893
• Locations: 1 country
• Sites: 3

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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV/AIDS; re-engagement in care; data to care

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

standard of care (SOC) arm

NO INTERVENTION

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

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)

Interventions

Anti-Retroviral Treatment and Access to Services (ARTAS) OTHER

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).

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Deceased
• Out of jurisdiction
• Changed providers
• Incarcerated

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Connecticut State, Department of Mental Health and Addiction Services: collaborator
• Massachusetts Department of Health: collaborator
• Philadelphia Department of Public Health: collaborator

Study Sites (3)

Connecticut Department of Public Health

Hartford, Connecticut, 06106, United States

Location

Massachusetts Department of Public Health

Boston, Massachusetts, 02108, United States

Location

Philadelphia Department of Health

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (13)

• 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.

  BACKGROUND

• 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.

  PMID: 25426654 BACKGROUND

• 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.

  PMID: 25706928 BACKGROUND

• 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. doi: 10.1097/01.aids.0000161772.51900.eb.

  PMID: 15750396 BACKGROUND

• 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. doi: 10.1093/cid/cis623. Epub 2012 Jul 24.

  PMID: 22828593 BACKGROUND

• 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.

  PMID: 24837481 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23669157 BACKGROUND

• 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.

  PMID: 21767103 BACKGROUND

• Macharaviani E, Altice FL, Shrestha R, Truebig J, Carroll C, Nichols L, Ahmad B, Copenhaver M, Villanueva M. Disease Intervention Specialist Field Experience in Re-engaging Out-of-Care People with HIV in Project CoRECT: A Mixed Methods Study. AIDS Behav. 2025 Aug;29(8):2451-2460. doi: 10.1007/s10461-025-04707-w. Epub 2025 Apr 10.

  PMID: 40205311 DERIVED

• Machavariani E, Miceli J, Altice FL, Fanfair RN, Speers S, Nichols L, Jenkins H, Villanueva M. Using Data-To-Care Strategies to Optimize the HIV Care Continuum in Connecticut: Results From a Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2024 May 1;96(1):40-50. doi: 10.1097/QAI.0000000000003391.

  PMID: 38324241 DERIVED

• Elder H, Lang SG, Villanueva M, John B, Roosevelt K, Altice FL, Brady KA, Gibson B, Buchelli M, DeMaria A, Randall LM. Using the exploration, preparation, implementation, sustainment (EPIS) framework to assess the cooperative re-engagement controlled trial (CoRECT). Front Public Health. 2023 Dec 1;11:1223149. doi: 10.3389/fpubh.2023.1223149. eCollection 2023.

  PMID: 38106893 DERIVED

• O'Shea J, Fanfair RN, Williams T, Khalil G, Brady KA, DeMaria A Jr, Villanueva M, Randall LM, Jenkins H, Altice FL, Camp N, Lucas C, Buchelli M, Samandari T, Weidle PJ. The Cooperative Re-Engagement Controlled Trial (CoRECT): Durable Viral Suppression Assessment. J Acquir Immune Defic Syndr. 2023 Jun 1;93(2):134-142. doi: 10.1097/QAI.0000000000003178.

  PMID: 36812382 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

US (3)