# Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT

> **NIH NIH R01** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2020 · $704,117

## Abstract

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. This application, “Hydroxyurea Adherence for Personal Best in Sickle Cell
Treatment: HABIT,” responds to PA-14-029, “Chronic Condition Self-Management in Children and
Adolescents.” The proposed study, a 5-site four-year randomized control trial (RCT), stems directly from
our recent R21-funded feasibility study of the same title. Overall goals of reducing barriers to HU use and
improving adherence for youth 10-18 years through creation of a daily medication habit. The HABIT
feasibility study was delivered to a multi-ethnic sample of parent-youth dyads by culturally aligned
community health workers (CHWs), augmented by customized text messaging. The 2-site study
demonstrated intervention feasibility and acceptability in a multi-ethnic sample, as well as a sufficient
effect on the primary outcomes to power a multi-site efficacy trial. 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. The importance of the problem of poor medication adherence, use of CHWs to bridge the gap
between health services and underserved parent-youth dyads affected by SCD, the strength of the
science, the success of our 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. Specific Aims: Study
aims are to test the efficacy of the HABIT intervention to: Aim 1: Improve daily HU adherence, the
primary outcome operationalized two ways: biomarker (approach or exceed a historical Personal best
HbF) and pharmacy refill (primary outcome); Aim 2: Improve youth quality of life and self-management
responsibility concordance measured by three secondary outcomes: generic and disease-specific QOL
and parent/youth concordance regarding delegation of self-management responsibility (secondary
outcome); Aim 3: Improve health status measured by two secondary outcomes: acute hospital use (12
month hospital length of stay, admissions and emergency room visits) and self-reported disease
symptoms (fatigue, pain interference and intensity); Aim 4: Qualitatively assess impact and sustainability
of the intervention on developing a daily medication HU habit from the perspectives of the community
health workers (CHWs) and youth-parent-dyads using focus group and individual interviews. If proven
efficacious, this approach could be adapted to youth affected by other serious chronic conditions...

## Key facts

- **NIH application ID:** 9969094
- **Project number:** 5R01NR017206-04
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Nancy S. Green
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $704,117
- **Award type:** 5
- **Project period:** 2017-09-27 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969094

## Citation

> US National Institutes of Health, RePORTER application 9969094, Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT (5R01NR017206-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9969094. Licensed CC0.

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