Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 10 - 18 |
| Updated: | 3/15/2019 |
| Start Date: | September 10, 2018 |
| End Date: | June 2021 |
| Contact: | Arlene Smaldone, PhD, CPNP-PC |
| Email: | ams130@columbia.edu |
| Phone: | 212 342 3048 |
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.
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.
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) is characterized by chronic and acute illness and reduced quality of life
(QOL). It affects African Americans and other underserved communities. Hydroxyurea (HU) is
the sole FDA-approved drug therapy for SCD and is highly effective and improves QOL. Poor
adherence is common among youth and young adults with SCD.
The importance of poor medication adherence, use of community-based health workers (CHWs) to
bridge the gap between health services and underserved parent-youth dyads affected by SCD,
the strength of the science, the success of the investigators' multi-ethnic feasibility
study, and the potential application of study findings to youth with other serious chronic
illnesses speak to the importance of this trial.
racial/ethnic disparities in underserved communities. An inherited blood disease, Sickle Cell
Disease (SCD) is characterized by chronic and acute illness and reduced quality of life
(QOL). It affects African Americans and other underserved communities. Hydroxyurea (HU) is
the sole FDA-approved drug therapy for SCD and is highly effective and improves QOL. Poor
adherence is common among youth and young adults with SCD.
The importance of poor medication adherence, use of community-based health workers (CHWs) to
bridge the gap between health services and underserved parent-youth dyads affected by SCD,
the strength of the science, the success of the investigators' multi-ethnic feasibility
study, and the potential application of study findings to youth with other serious chronic
illnesses speak to the importance of this trial.
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 ≥20% 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
We found this trial at
4
sites
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Kim Smith-Whitley, MD
Phone: 267-426-0097
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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1300 Morris Park Ave
Bronx, New York 10461
Bronx, New York 10461
(718) 430-2000
Principal Investigator: Deepa Manwani, MD
Phone: 718-741-2402
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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Manhasset, New York 11030
Principal Investigator: Banu Aygun, MD
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Nancy S Green, MD
Phone: 212-342-3943
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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