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3901 Habit Efficacy Trial: A Multi-Site Randomized Controlled Trial of Community Health Worker Support to Increase Hydroxyurea Adherence of Youth with Sickle Cell Disease

Program: Oral and Poster Abstracts
Session: 114. Sickle cell Disease, Sickle Cell Trait and Other Hemoglobinopathies, Excluding Thalassemias: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Research, clinical trials, Clinical Research
Monday, December 11, 2023, 6:00 PM-8:00 PM

Nancy S. Green, MD1, Deepa Manwani, MD2, Banu Aygun, MD3, Abena Appiah-Kubi, MD, MPH4, Kim Smith-Whitley, MD5,6, Haomiao Jia, PhD7* and Arlene Smaldone8*

1Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia U. Medical Center Div. of Pediatric Hematology/Oncology/Stem Cell Trans, New York, NY
2Department of Pediatric Hematology-Oncology, Albert Einstein College of Medicine, Bronx, NY
3Division of Pediatric Hematology/Oncology and Cellular Therapy, Cohen Children's Medical Center, New Hyde Park, NY
4Cohen Children's Medical Center, Cohen Children's Medical Center, New Hyde Park, NY
5Division of Hematology, Children's Hospital of Philadelphia, Philadelphia, PA
6Pfizer, Inc., New York, NY
7School of Nursing, Columbia University Irving Medical Center, New York, NY
8Columbia University School of Nursing, New York, NY

Introduction: Despite disease-modifying effects of hydroxyurea (HU) on sickle cell disease (SCD), poor adherence among affected youth commonly impedes treatment impact. The HABIT multi-site randomized controlled efficacy trial aimed to increase HU adherence.

Methods: Youth with SCD ages 10-18 years with impaired adherence were identified through laboratory evidence, primarily flagging levels of treatment-induced fetal hemoglobin (HbF). Eligible youth were enrolled as dyads with their primary caregivers for one year. We tested a 6-month phase of semi-structured supportive, multi-dimensional dyad intervention led by community health workers (CHW) with 4-5 visits addressing information, social issues/referrals, barriers, habit formation using goal-setting and cues, augmented by daily tailored automated text message reminders, compared to standard care. This phase was followed by a 6-month sustainability phase (months 7-12) of observation and, for the intervention group, 1 CHW booster visit. Primary intervention outcomes were 1) HbF levels compared to enrollment; and 2) proportion of days covered (PDC) for HU versus the pre-trial year. The secondary outcome was sustainability of these changes up to month 12.

Results: Starting in 2020, the COVID-19 pandemic disrupted enrollment and clinic-based procedures. The trial enrolled 50 dyads, missing target enrollment. Compared to enrollment levels, both HbF level and PDC significantly improved within the intervention group at month 6 (p=.03 and .01, respectfully), with parallel increased MCV (p=.05). Increased HbF did not reach signifance compared to controls (p=.07). No significant within- or between-group differences were found at month 12.

Conclusions: Within-group results suggest that our CHW-based dyad intervention with text message reminders improved HU adherence at 6 months but there were no between-group differences. Effects did not endure through the subsequent 6-month sustainability phase. These findings suggest that improved HU adherence for youth with SCD though our community-based, multi-modal support for youth-caregiver dyads temporarily improved usage. Durability of impact on adherence may require integrating CHW-led support and text reminders into clinical care.

Disclosures: Green: AddMedica: Other: Donated study drug for an NIH-funded clinical trial. Manwani: Novartis, Pfizer, Novo Nordisk, Editas, GBT: Consultancy. Aygun: bluebird bio: Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding; GBT: Membership on an entity's Board of Directors or advisory committees; Agios: Membership on an entity's Board of Directors or advisory committees. Smith-Whitley: Pfizer, Inc.: Current Employment.

*signifies non-member of ASH