Actively Recruiting

Age: 13Years +
All Genders
Healthy Volunteers
NCT04416178

Sickle Cell Disease and the Genomic and Gene Therapy Needs of Stakeholders

Led by St. Jude Children's Research Hospital · Updated on 2026-05-01

352

Participants Needed

1

Research Sites

310 weeks

Total Duration

On this page

Sponsors

S

St. Jude Children's Research Hospital

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objectives of this prospective mixed-method interview study are to use semi-structured interviews in parents of sickle cell disease (SCD) patients to describe parental attitudes of research involving genomic sequencing, including concerns about participation and expectations from researchers and second, to use surveys to quantitatively measure genetic/genomic knowledge, trust in health care provider, and literacy/numeracy ability in parents of children with SCD and adolescents with SCD. Secondary objectives are development of a web-based tool about treatment options for SCD that fosters patient-clinician communication and promotes shared decision-making. The web-based tool will undergo usability and pilot testing to ensure it is accessible to families and provide data about strategies for integrating into clinical conversations about treatment options. Investigators will use the data generated to reduce the risk of misunderstanding about DNA and genetic research and build strong relationships between SCD families and researchers in the future. The project will design educational information and study materials to help parents of children with SCD understand important details about genomic medicine in SCD care.

CONDITIONS

Official Title

Sickle Cell Disease and the Genomic and Gene Therapy Needs of Stakeholders

Who Can Participate

Age: 13Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parent of child with HbSS, HbS/ β0 thalassemia, or HbSC aged 12 months to 18 years at study start, or patient aged 13 to 18 years with these SCD types
  • Informed consent from parent or legal guardian and assent from adolescent participant
  • Has been previously approached for SCRIPP (for Group 1)
  • Adult patient or parent of child with HbSS, HbS/ β0 thalassemia, β+ thalassemia, or HbSC aged 12 months to 18 years at study start, or patient aged 16 to 18 years with these SCD types (for Group 2)
  • Parent of child or patient aged 13 and up with HbSS, HbS/ β0 thalassemia, β+ thalassemia, or HbSC (for Group 3)
Not Eligible

You will not qualify if you...

  • Unable to speak English fluently
  • Condition or chronic illness making participation unsafe or untenable (such as cognitive impairment or acute illness), as judged by the investigator
  • Unable or unwilling to provide written informed consent or assent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

L

Liza M. Johnson, MD, MPH, MSB

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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