Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial

Locations

4 United States sites

Age

10 to 18 Years

Genotypes

HbSS

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Behavioral

Compensation

Unknown

About the study

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 affects African Americans and other underserved communities. Hydroxyurea (HU) is
the sole FDA-approved drug therapy for SCD and is highly effective and improves quality of
life. The proposed study, a 5-site four-year randomized control trial (RCT), builds upon the
investigators’ recent feasibility study of the same title. Overall goals are reducing
barriers to HU use and improving adherence for youth 10-18 years through creation of a daily
medication habit. The goal of the proposed multi-site study is to test the efficacy of the
HABIT intervention at 6 months and sustainability of the effect at 12 months.

participation requirements

– 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

participation restrictions

– 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

Locations

  • Bronx, New York, United States, Albert Einstein College of Medicine, 10461
  • Manhasset, New York, United States, Feinstein Institute for Medical Research, 11030
  • New York, New York, United States, Columbia University Medical Center, 10032
  • Philadelphia, Pennsylvania, United States, The Children's Hospital of Philadelphia, 19104