Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The investigators propose that culturally aligned community-based interventions in our
      multi-ethnic sickle cell disease (SCD) population, augmented by task-focused communication
      technology, can improve self-managed adherence to hydroxyurea (HU) by decreasing barriers to
      use, supporting parent-youth partnerships for chronic disease self-management and reinforcing
      the behavior of daily medication use. Culturally aligned community health workers (CHW) are a
      well-established means to support chronic disease self-management by underserved families, in
      partnership with medical homes. CHWs can identify and address multiple barriers and reinforce
      developmentally appropriate self-management to help youth reach and maintain their best fetal
      hemoglobin (HbF) levels. However, this strategy alone may be insufficient to achieve daily HU
      adherence. The investigators therefore propose a feasibility trial to test the feasibility
      and acceptability of a structured intervention of CHW support to address existing barriers to
      improve HU use, augmented by daily cue-based parent and youth text message reminders, to
      efficiently extend CHW family support and reinforce family partnerships for self-management.
    

Detailed description: 
      Sickle cell disease (SCD) is an inherited disorder affecting the blood and causes anemia,
      painful sickle crises, organ damage, reduced quality of life and high health care use.
      Hydroxyurea (HU) is an oral medication that reduces disease symptoms and improves quality of
      life by increasing the amount of fetal hemoglobin in the blood. Despite the clinical promise
      of hydroxyurea, many children with SCD do make taking hydroxyurea a daily health habit.
      General barriers to medication adherence in underserved populations include lack of trust of
      medical staff, incomplete knowledge regarding benefits of hydroxyurea, and other factors that
      impede access to care such as transportation difficulties. Challenges specific to hydroxyurea
      use include understanding the importance of maximizing fetal hemoglobin levels and addressing
      concerns about hydroxyurea. Children and adolescents also require that a developmentally
      appropriate transition of self-management be established with their parents. Community-based
      health workers are a well established means to provide support for chronic disease management
      for underserved families and address multi-faceted barriers through culturally, behaviorally
      and developmentally aligned intervention. The investigators hypothesize that Community Health
      Workers support, augmented by daily task-focused communication technology, can improve
      self-managed adherence to hydroxyurea.
    

Intervention name(s): Community Health Worker (CHW); Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CHWs will have scheduled interactions with subjects at home, by telephone or at Community League of the Heights (CLOTH), our partner community-based organization (CBO). CHWs will customize text messaging jointly with each youth and parent (Month 3) and text message reminders to both parent and youth will be implemented during Months 4-6. Subjects lacking a mobile phone or sufficient cell phone plan will be compensated to purchase or upgrade plans to accommodate texts.; Dyads randomized to the control group will continue usual clinic-based care, including monitoring and review of HbF levels, and similar frequency of clinic visits and access to sickle cell team staff. They will be provided with educational materials about sickle cell disease and hydroxyurea use for children.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sickle cell disease; Medication adherence; Hydroxyurea; Community health worker intervention; Sickle Cell Treatment