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NCT03462511 · ClinicalTrials.gov registry record · NA
Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT03462511: Completed NA study, sponsored by Columbia University.
NCT03462511 is a NA study that has completed, run by Columbia University. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03462511, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study 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 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.
Primary Outcome
A serum biomarker obtained from youth used to measure adherence to hydroxyurea
Interventions
- OTHER Standard of Care
- BEHAVIORAL HABIT Intervention
- OTHER Education materials
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-08-15 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
What the finished NCT03462511 record still lists
NCT03462511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard of Care is the first listed.
NCT03462511 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03462511 about?
NCT03462511 is a clinical study titled "Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial". 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 dr...
What is the current status of trial NCT03462511?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2018-08-15. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT03462511?
The interventions under investigation include: Standard of Care (OTHER), HABIT Intervention (BEHAVIORAL), Education materials (OTHER).
Who is sponsoring clinical trial NCT03462511?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03462511's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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