Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

18. februar 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

1893

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Connecticut
      • Hartford, Connecticut, Forente stater, 06106
        • Connecticut Department of Public Health
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02108
        • Massachusetts Department of Public Health
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Philadelphia Department of Health

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: 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.
Annen: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Attend one clinic visit
Tidsramme: 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
Tidsramme: 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
Tidsramme: within 12 months
Does the patient achieve viral load suppression within 12 months of randomization
within 12 months
Achieve durable viral load suppression
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centers for Disease Control and Prevention

Samarbeidspartnere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2016

Primær fullføring (Faktiske)

1. august 2020

Studiet fullført (Faktiske)

1. august 2020

Datoer for studieregistrering

Først innsendt

23. februar 2016

Først innsendt som oppfylte QC-kriteriene

25. februar 2016

Først lagt ut (Anslag)

26. februar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FOA PS14-001

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere