- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02693145
Cooperative Re-Engagement Controlled Trial (CoRECT) (CoRECT)
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Department of Public Health
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Massachusetts
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Boston, Massachusetts, United States, 02108
- Massachusetts Department of Public Health
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Philadelphia Department of Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- Deceased
- Out of jurisdiction
- Changed providers
- Incarcerated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: standard of care (SOC) arm
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.
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Experimental: Intervention arm
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.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attend one clinic visit
Time Frame: within 90 days of randomization
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Patient will attend one clinical visit at CoRECT clinic to receive HIV medical care
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within 90 days of randomization
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Remain engaged in care
Time Frame: defined as 2 clinic visits at least 3 months apart within 12 months
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Two or more medical visits at least 3 months apart within 12 months to demonstrate patient remains engaged in HIV medical care
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defined as 2 clinic visits at least 3 months apart within 12 months
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Viral load suppression
Time Frame: within 12 months
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Does the patient achieve viral load suppression within 12 months of randomization
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within 12 months
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Achieve durable viral load suppression
Time Frame: defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
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Achieve durable viral load suppression, defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
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defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Anti-Infective Agents
- Antiviral Agents
- Anti-Retroviral Agents
Other Study ID Numbers
- FOA PS14-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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