mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria

NCT06318143 | Recruiting DMC

• 1 other identifier: U01HL168084
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (3)

• Patient numbers - screening

  The number of patients taking HU identified through screening

  12 months

• Patient numbers - proportion on HU

  The proportion of patients that on HU based on the REACH Clinical Trial algorithm tailored for aged 12 months through adulthood using SPARCO HU Guidelines

  12 months

• Patient numbers - dosage

  Proportion of patients who maintained HU dosage

  12 months

Secondary Outcomes (1)

• Mediators

  12 months and 24 months

Study Arms (2)

SIM Only

ACTIVE COMPARATOR

Provision of information about task sharing (Education)

Other: SIM

SIM + TASSH TCP

EXPERIMENTAL

replicable evidence-based task-sharing strategy,TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH)

Behavioral: TASSH

Interventions

TASSH BEHAVIORAL

Strategy for Hemoglobinopathies (TASSH) 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 (Figure 1A describes the components of the intervention).

SIM + TASSH TCP

SIM OTHER

Provision of information about task sharing (Education)

SIM Only

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• SCD patients18 years older that have provided consent;
• Pediatric SCD patients aged 12 months to 17 years with an accompanying guardian and have provided informed consent or assent;
• Registration in the electronic medical records (EMR) database with clinical charts and received care at the local clinical sites or health facilities and not on HU therapy;
• Hb Genotype: SCD-SS, SCD-Sβo thal, SCD-SOArab (On a case by case basis, a severely affected person with SCD-SC may be offered HU therapy under a modified treatment protocol)

You may not qualify if:

• Any SCD patient not registered in the EMR database without informed consent or assent;
• Physically unable to participate in study activities;
• An SCD patient on HU

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

University Of Abuja Teaching Hospital

Abuja, Nigeria

RECRUITING

Related Publications (1)

• Peprah E, Gyamfi J, Patena J, Kayalioglu H, Hameed T, Ogedegbe G, Do H, Ojji D, Adenikinju D, Ajaye Oba T, Nwegbu M, Isa H, Shedul G, Sopekan AY, Nnodu OE. An implementation trial to mAnage siCkle CELl disEase through incReased AdopTion of hydroxyurEa in Nigeria (ACCELERATE): Study protocol. PLoS One. 2025 Jan 8;20(1):e0311900. doi: 10.1371/journal.pone.0311900. eCollection 2025.

  PMID: 39774400 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Emmanuel Peprah, PhD

CONTACT

212-992-6085; ep91@nyu.edu

Obiageli Nnodu

CONTACT

oennodu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 19, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 13, 2026

Record last verified: 2025-07

Locations

NG (1)