CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
HABIT Intervention +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03462511
NCT03462511N/ACompleted

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

Columbia University·interventional·Posted Mar 12, 2018·Updated Jun 26, 2024

In Brief

A clinical study evaluating HABIT Intervention, Standard of Care, and 1 other intervention for Sickle Cell Disease. Completed, enrolled 50 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 12, 2018
Enrollment StartAug 15, 2018
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.3 years ago

Interventions

HABIT Interventionbehavioral

Dyads randomized to the intervention group will receive the HABIT intervention, which includes CHW support and tailored text messages.

Standard of Careother

Standard of care used to treat patients with SCD

Education materialsother

Education materials provided to all patients enrolled in the trial