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RecruitingSickle Cell Disease

Gene Therapy Communication: Use of a Needs Assessment to Drive Decision-AIDS for Gene Therapy for Rare Diseases (GENETX)

Eligible age

8+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

This prospective mixed-method interview study aims to qualitatively describe the beliefs, attitudes, and informational needs around gene therapy for rare pediatric diseases among patients and parents of children with a rare disease targeted for treatment using gene therapy techniques. Using learned insights, the team will develop an online platform providing educational content and patient decision aids for patients and their families.

Sponsor: St. Jude Children's Research Hospital

You may qualify if…

  • 1. For Group 1 participants only (Undergone Gene Therapy):
  • Parent/caregiver whose child has undergone gene therapy. OR Parent/caregiver of a child who died after receiving gene therapy at least 6 months prior to enrollment, but no more than 24 months prior to enrollment, to be contacted no sooner than 3 months after the death has occurred and no longer than 2 years. OR Patients age 8 and above who have undergone gene therapy.
  • Willingness to participate in one-on-one video interview with a study team member using a personal mobile device or computer with working internet connection.
  • Must be willing to provide verbal informed consent.
  • Release of information form signed by participant providing our study team with permission to contact healthcare provider to verify their diagnosis and receipt of gene therapy (if received).
  • Successful verification of diagnosis of rare genetic disease targeted for treatment using gene therapy.
  • A positive confirmation on receipt of gene therapy and type received from their healthcare provider (only for those received gene therapy).
  • 2. For Group 2 participants only (Offered, but did not Undergo Gene Therapy):

You may not qualify if…

  • Participants who are unable to converse fluently in English will be excluded.
  • Inability or unwillingness of research participant to give verbal informed consent.
  • Participants who lack access to a computer or mobile device that supports video communications will be excluded.
  • Condition or chronic illness, which in the opinion of the PI/Co-I, makes participation unsafe or untenable (i.e., cognitive impairment, concurrent acute morbidity).

Where it's recruiting

Tennessee

Memphis

Source: ClinicalTrials.gov · NCT05810181 · last updated 2026-05-07

Gene Therapy Communication: Use of a Needs Assessment to Drive Decisio · TrialPath