Clinical Trial 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.
Aim 1: Using the EPIS framework as a guide, identify and characterize the capacity of 20
SPARC-NEt clinical sites to adopt SIM and adapt a tailored healthcare worker TASSH Training +
Clinical reminders + Practice facilitation (TASSH TCP) for SCD management.
Aim 2: Evaluate in a cluster RCT, the effect of the TASSH TCP (experimental condition) vs.
receipt of educational information only on TASSH TCP (control) on the adoption of SIM
(primary outcome) across 20 SPARC-NEt clinical sites at 12 months. Hypothesis 1: The level of
SIM adoption will be higher in the SPARC- NEt clinical sites randomized to the experimental
condition than those in control.
Aim 3: Evaluate the mediators of SIM+TASSH TCP adoption, implementation fidelity, and
sustainability across SPARC-NEt clinical sites at 12 and 24 months. Hypothesis 2: Inner
organizational context, outer context, and implementation process will influence adoption,
fidelity, and sustainability of SIM+TASSH TCP at clinical sites.
Impact: The study leverages the infrastructure of the SPARC-NEt (U01HL156942) of Nigeria to
assess the adoption of HU among providers to improve SCD management in a manner that is
scalable and sustainable across Nigeria and identify best practices for implementing HU
therapy in resource constrained settings.