2019
DOI: 10.1186/s12887-019-1746-6
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HABIT efficacy and sustainability trial, a multi-center randomized controlled trial to improve hydroxyurea adherence in youth with sickle cell disease: a study protocol

Abstract: Background Hydroxyurea (HU) is recommended as standard practice for youth with sickle cell disease (SCD). Yet, despite its efficacy, HU adherence in adolescents and young adults is often poor. Poor medication adherence increases disease burden, healthcare cost and widens health disparities. Adolescence is a critical time to improve adherence through improved chronic disease self-management. This study aims to test the efficacy of an intervention delivered to youth/parent dyads by community heal… Show more

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Cited by 13 publications
(30 citation statements)
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“…[3][4][5] Although the clinical efficacy of HU in preventing pain has been demonstrated, [6][7][8] and its ability to increase life expectancy suggested, 9,10 many publications continue to report low/poor adherence to HU, 11,12 associated with a poor quality of life and school absenteeism. [13][14][15] Reluctance to use HU may be partially related to fears about potential side effects of this medication, especially in terms of fertility and carcinogenicity. 16 As malignancies are rare events, safety assessment requires very large-scale studies covering long periods of follow-up.…”
Section: Introductionmentioning
confidence: 99%
“…[3][4][5] Although the clinical efficacy of HU in preventing pain has been demonstrated, [6][7][8] and its ability to increase life expectancy suggested, 9,10 many publications continue to report low/poor adherence to HU, 11,12 associated with a poor quality of life and school absenteeism. [13][14][15] Reluctance to use HU may be partially related to fears about potential side effects of this medication, especially in terms of fertility and carcinogenicity. 16 As malignancies are rare events, safety assessment requires very large-scale studies covering long periods of follow-up.…”
Section: Introductionmentioning
confidence: 99%
“…There are some ongoing projects exploring CHWs for SCD. Smaldone et al (2019) shared a protocol for a study aiming at testing the efficacy of an intervention delivered to youth/parent dyads by CHWs, augmented by tailored text messages on medication adherence. In their feasibility study, CHWs worked with people and families for improved understanding of SCD and medication adherence, identified and addressed barriers to medication adherence, built youthparent disease self-management partnerships, and identified a cue on which a medication habit could be built (Green et al 2017).…”
Section: Discussionmentioning
confidence: 99%
“…Fifty dyads of youth with SCD ages 10–18 years and their primary caregivers enrolled in our multi‐site randomized, controlled trial, HABIT (“Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment”) aimed at improving youth's adherence to hydroxyurea therapy, based on their flagging fetal hemoglobin levels. 19 The HABIT trial was conducted from 2018 through 2021 at four pediatric SCD centers located in New York City and Philadelphia. Trial enrollment occurred between May 2018 and December 2020, with 89% enrolled prior to onset of the COVID‐19 pandemic.…”
Section: Introductionmentioning
confidence: 99%