mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria - Trial NCT06318143

Timeline & Enrollment

Primary Outcome

Patient numbers - screening,Patient numbers - proportion on HU,Patient numbers - dosage

Summary

Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU),
 particularly in sub-Saharan African countries including Nigeria, where more than 75% of
 annual sickle cell anemia births occur. The vast majority of people with SCD in Africa do not
 receive evidenced-based health care (e.g., newborn screening, health education, prophylaxis
 for infection, optimal nutrition and hydration, blood transfusion, transcranial Doppler
 screening, and HU therapy), despite its effectiveness in reducing SCD-related adverse
 outcomes and mortality. The use of HU in SSA is 1% among SCD patients. The investigators'
 preliminary findings indicate that provider-level barriers are significant and must be
 addressed to improve HU adoption. To address HU adoption, the investigators will use the
 NIH-funded study (e.g., Realizing Effectiveness Across Continents with Hydroxyurea (REACH)
 Clinical Trial (NCT01966731)) that developed an evidence-informed, clinical, practical, and
 easy-to-follow algorithm to 1) Screen patients for sickle cell disease (SCD), 2) Initiate HU
 treatment, and 3) Maintain HU dosage over time (SIM) for the improved management of SCD as
 our intervention. The Nigerian government released guidelines supporting the SIM intervention
 for HU adoption for improved SCD management, and HU is on the list of essential medicines for
 Nigeria. The investigators' implementation strategy for improving SCD management in Nigeria
 uses a practical and replicable evidence-based task-sharing strategy, TAsk-Strengthening
 Strategy for Hemoglobinopathies (TASSH), adopted from the TAsk-Strengthening Strategy for
 Hypertension control (TASSH) trials in Ghana and Nigeria containing the essential components
 of i) Training healthcare workers/providers to be more patient-centered in clinical
 consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH
 TCP) for SCD management. Using a sequential exploratory mixed-methods study design, the
 investigators will conduct this study using the Exploration, Preparation, Implementation, and
 Sustainment (EPIS) framework in four sequential phases to assess the effectiveness of SIM
 adoption by providers in the context of the TASSH TCP implementation strategy in Nigeria.

ICD-10 Classifications