Cross Sectional CFAR HIV/COVID-19 Study

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; SARS-CoV Infection

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Batchelor's Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-positive pediatric, adolescent or young adult being treated at Batchelor Children Research Institute (BCRI) at the University of Miami.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who tested positive with SARS COV-2 Infection	SARS COV-2 Infection will be analyzed from nasopharyngeal swab samples via RT-PCR assay	month 3
Number of participants who tested positive with SARS COV-2 antibody	SARS COV-2 antibody will be analyzed from blood samples via serological assay	month 3

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Miami Center for AIDS Research (CFAR)
• Investigators: Principal Investigator: Charles Mitchell, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): March 17, 2021
• Study Completion (Actual): March 17, 2021

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: HIV
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Infections
• Other Study ID Numbers: 20200802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No