Abstract
Despite disease-modifying effects of hydroxyurea on sickle cell disease (SCD), poor adherence among affected youth commonly impedes treatment impact. Following our prior feasibility trial, the “Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment (HABIT)” multi-site randomized controlled efficacy trial aimed to increase hydroxyurea adherence for youth with SCD ages 10–18 years. Impaired adherence was identified primarily through flagging hydroxyurea-induced fetal hemoglobin (HbF) levels compared to prior highest treatment-related HbF. Eligible youth were enrolled as dyads with their primary caregivers for the 1-year trial. This novel semi-structured supportive, multidimensional dyad intervention led by community health workers (CHW), was augmented by daily tailored text message reminders, compared to standard care during a 6-month intervention phase, followed by a 6-month sustainability phase. Primary outcomes from the intervention phase were improved Month 6 HbF levels compared to enrollment and proportion of days covered (PDC) for hydroxyurea versus pre-trial year. The secondary outcome was sustainability of changes up to Month 12. The 2020–2021 peak coronavirus disease 2019 (COVID-19) pandemic disrupted enrollment and clinic-based procedures; CHW in-person visits shifted to virtual scheduled interactions. We enrolled 50 dyads, missing target enrollment. Compared to enrollment levels, both HbF level and PDC significantly - but not sustainably - improved within the intervention group (p =.03 and.01, respectively) with parallel increased mean corpuscular volume (MCV) (p =.05), but not within controls. No significant between-group differences were found at Months 6 or 12. These findings suggest that our community-based, multimodal support for youth–caregiver dyads had temporarily improved hydroxyurea usage. Durability of impact should be tested in a trial with longer duration of CHW-led and mobile health support.
| Original language | English |
|---|---|
| Article number | e30878 |
| Journal | Pediatric Blood and Cancer |
| Volume | 71 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Apr 2024 |
Bibliographical note
Publisher Copyright:© 2024 Wiley Periodicals LLC.
Funding
We thank the participating youth and their caregivers for their trial participation, especially during the COVID‐19 pandemic. We also thank the study staff and community health workers at each study site for their efforts. This work was supported by National Institute of Nursing Research at the National Institutes of Health, Grant Number: 1R01NR017206.
| Funders | Funder number |
|---|---|
| National Institutes of Health | 1R01NR017206 |
| National Institute of Nursing Research |
ASJC Scopus Subject Areas
- Pediatrics, Perinatology, and Child Health
- Hematology
- Oncology