Cross Sectional CFAR HIV/COVID-19 Study

NCT04514016 | Completed

• 1 other identifier: 20200802
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV Infection; Covid19

Keywords

HIV

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Miami Center for AIDS Research (CFAR): collaborator

Study Sites (1)

Batchelor's Children's Research Institute

Miami, Florida, 33136, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Nasopharyngeal swab samples

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Charles Mitchell, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 14, 2020
• Study Start: August 12, 2020
• Primary Completion: March 17, 2021
• Study Completion: March 17, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)