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Despite its well-described safety and efficacy in the treatment of sickle cell anemia (SCA) in high-income settings, hydroxyurea remains largely unavailable in sub-Saharan Africa, where more than 75% of annual SCA births occur and many comorbidities exist. Realizing Effectiveness Across Continents with Hydroxyurea (REACH, ClinicalTrials.gov NCT01966731) is a prospective, Phase I/II open-label trial of hydroxyurea designed to evaluate the feasibility, safety, and benefits of hydroxyurea treatment for children with SCA in four sub-Saharan African countries. Following comprehensive training of local research teams, REACH was approved by local Ethics Committees and achieved full enrollment ahead of projections with 635 participants enrolled over a 30-month period, despite half of families living >12 km from their clinical site. At enrollment, study participants (age 5.4 ± 2.4 years) had substantial morbidity, including a history of vaso-occlusive pain (98%), transfusion (68%), malaria (85%), and stroke (6%). Significant differences in laboratory characteristics were noted across sites, with lower hemoglobin concentrations (P 

Original publication

DOI

10.1002/ajh.25034

Type

Journal

American journal of hematology

Publication Date

08/2018

Volume

93

Pages

537 - 545

Addresses

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.

Keywords

REACH Investigators, Humans, Malaria, Ischemia, Anemia, Sickle Cell, Glucosephosphate Dehydrogenase Deficiency, alpha-Thalassemia, Hydroxyurea, Blood Transfusion, Combined Modality Therapy, Prospective Studies, Feasibility Studies, Comorbidity, Child, Child, Preschool, Africa South of the Sahara, Female, Male, Stroke, Global Health