Actively Recruiting

Phase Not Applicable
Age: 12Months +
All Genders
Healthy Volunteers
NCT06318143

mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria

Led by New York University · Updated on 2026-05-13

900

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria

Who Can Participate

Age: 12Months +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • SCD patients 18 years or older who have provided consent
  • Pediatric SCD patients aged 12 months to 17 years with an accompanying guardian who have provided informed consent or assent
  • Registration in the electronic medical records (EMR) database with clinical charts and receiving care at local clinical sites or health facilities
  • Patients not currently on hydroxyurea (HU) therapy
  • Hb Genotype includes SCD-SS, SCD-Sβ0 thal, SCD-SOArab; on a case-by-case basis, severely affected SCD-SC patients may be offered HU under a modified protocol
Not Eligible

You will not qualify if you...

  • Any SCD patient not registered in the EMR database or without informed consent or assent
  • Patients physically unable to participate in study activities
  • SCD patients currently on hydroxyurea (HU) therapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Of Abuja Teaching Hospital

Abuja, Nigeria

Actively Recruiting

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Research Team

E

Emmanuel Peprah, PhD

CONTACT

O

Obiageli Nnodu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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