Status:
COMPLETED
Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
10-18 years
Phase:
NA
Brief Summary
Many youth with chronic disease have difficulty taking medication every day and therefore do not receive full benefit from treatment. Sickle Cell Disease (SCD) is an inherited blood disease that affec...
Detailed Description
Barriers to medication adherence are common in youth with chronic illness and are a source of racial/ethnic disparities in underserved communities. An inherited blood disease, Sickle Cell Disease (SCD...
Eligibility Criteria
Inclusion
- Inclusion Criteria - Youth:
- One of the two most common sickle cell disease variants (HbSS or HbS-B0 thalassemia)
- Age 10 through18 years (inclusive)
- Currently prescribed hydroxyurea (HU) ≥18 months (for identifying historical Personal best HbF)
- Current HU dose is within 5% of dose at Personal Best HbF
- Pre-enrollment HbF ≥15% below historical Personal best, based on mean of ≥2 HbF assessments over preceding 12 months
- Youth able to speak/read English or Spanish
- Inclusion Criteria - Parent:
- Parent/guardian speaks/reads English or Spanish
- Parent/ legal guardian willing to participate
- Family expects to reside in community for ≥ 1.5 years
- Exclusion Criteria - Youth:
- Youth not prescribed HU
- \<2 HbF assessments over past 12 months
- Transfusion within 3 months preceding enrollment
- Final screen HbF (visit 0) of ≤15% decrease below Personal best HbF
- Sexually active female 10 years or older and not using reliable contraception (due to HU teratogenic risk)
- Pregnancy
- Cognitive impairment (\>2 levels below expected grade)
- Youth not residing with parent/legal guardian
- Exclusion Criteria - Parent:
- Parent/legal guardian does not reside with youth
Exclusion
Key Trial Info
Start Date :
August 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03462511
Start Date
August 15 2018
End Date
December 31 2021
Last Update
June 26 2024
Active Locations (4)
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1
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
2
Columbia University Irving Medical Center
New York, New York, United States, 10032
3
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461
4
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104