Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention. Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials.

NCT Number	NCT06264700
Lead Sponsor	Nationwide Children's Hospital Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago, Hasbro Children's Hospital, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Sickle Cell Disease
Enrollment	60 participants
Start Date	2024-07-11
Primary Completion	2025-12 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-08