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Cross Sectional CFAR HIV/COVID-19 Study

Sponsor
University of Miami (Other)
Overall Status
Completed
CT.gov ID
NCT04514016
Collaborator
Miami Center for AIDS Research (CFAR) (Other)
64
Enrollment
1
Location
7.1
Actual Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this research study is to learn the rate of SARS COV-2 on HIV infected children, adolescents, and youth receiving their primary HIV care at the University of Miami Miller School of Medicine.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    64 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cross Sectional Survey Of Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV-2) Infection And Seroprevalence In A Cohort Of HIV-Infected Children, Youth, And Adolescents
    Actual Study Start Date :
    Aug 12, 2020
    Actual Primary Completion Date :
    Mar 17, 2021
    Actual Study Completion Date :
    Mar 17, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    HIV positive participants with positive COVID-19 results

    Participants in this group will have a RT-PCR and Coronavirus Disease (COVID) -19 specific antibody testing at baseline, 1 month and 3 month visits.
    HIV positive participants with negative COVID-19 results

    Participants in this group will have a RT-PCR and COVID-19 specific antibody testing at baseline only.

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants who tested positive with SARS COV-2 Infection [month 3]

      SARS COV-2 Infection will be analyzed from nasopharyngeal swab samples via RT-PCR assay

    2. Number of participants who tested positive with SARS COV-2 antibody [month 3]

      SARS COV-2 antibody will be analyzed from blood samples via serological assay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 25 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Being a patient to the Pediatric or Adolescent clinic located at Batchelor Children Research Institute (BCRI)

    • Being diagnosed with HIV infection by the time of enrollment

    • At enrollment, 3 to < 26 years

    Exclusion Criteria:

    • Patient will be excluded from the study if any of the following are identified:

    • Patients under legal age and in the State's custody

    • Participant or legal guardian unable to sign Informed Consent forms

    • Participant unable to complete study visits

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Batchelor's Children's Research Institute Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami
    • Miami Center for AIDS Research (CFAR)

    Investigators

    • Principal Investigator: Charles Mitchell, MD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charles Mitchell, Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT04514016
    Other Study ID Numbers:
    • 20200802
    First Posted:
    Aug 14, 2020
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Charles Mitchell, Professor, University of Miami
    HIV
    Additional relevant MeSH terms:
    Infections
    COVID-19
    Severe Acute Respiratory Syndrome

    Study Results

    No Results Posted as of Mar 23, 2021