Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318143
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-02-20
Brief Title:
mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria
Sponsor:
New York University
Organization:
New York University
Study Overview
Official Title:
mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCELERATE
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 eg 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 eg 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 workersproviders 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
Detailed Description:
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 SIMTASSH 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 SIMTASSH 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
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 SIMTASSH 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 SIMTASSH 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None