Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial
Completed · Not applicable
Conditions studied: Sickle Cell Disease
In brief
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.
Key facts
- Study ID
- NCT03462511
- Run by
- Columbia University
- People needed
- 50
- Starts
- 2018-08-15
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2024-06-26
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Feinstein Institute for Medical Research — Manhasset, New York, United States
- Columbia University Irving Medical Center — New York, New York, United States
- Albert Einstein College of Medicine — The Bronx, New York, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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