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Cooperative Re-Engagement Controlled Trial (CoRECT) (CoRECT)

18 februari 2021 bijgewerkt door: Centers for Disease Control and Prevention
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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Werkelijk)

1893

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Connecticut
      • Hartford, Connecticut, Verenigde Staten, 06106
        • Connecticut Department of Public Health
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02108
        • Massachusetts Department of Public Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • Philadelphia Department of Health

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 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.
Experimenteel: 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.
Ander: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Attend one clinic visit
Tijdsspanne: within 90 days of randomization
Patient will attend one clinical visit at CoRECT clinic to receive HIV medical care
within 90 days of randomization
Remain engaged in care
Tijdsspanne: 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
defined as 2 clinic visits at least 3 months apart within 12 months
Viral load suppression
Tijdsspanne: within 12 months
Does the patient achieve viral load suppression within 12 months of randomization
within 12 months
Achieve durable viral load suppression
Tijdsspanne: 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
defined as 2 consecutive suppressed viral load results at least 3 months apart within 18 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centers for Disease Control and Prevention

Medewerkers

Connecticut State, Department of Mental Health and Addiction Services
Massachusetts Department of Health
Philadelphia Department of Public Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2016

Primaire voltooiing (Werkelijk)

1 augustus 2020

Studie voltooiing (Werkelijk)

1 augustus 2020

Studieregistratiedata

Eerst ingediend

23 februari 2016

Eerst ingediend dat voldeed aan de QC-criteria

25 februari 2016

Eerst geplaatst (Schatting)

26 februari 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 februari 2021

Laatste update ingediend die voldeed aan QC-criteria

18 februari 2021

Laatst geverifieerd

1 februari 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FOA PS14-001

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