- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06318143
mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria (ACCELERATE)
Study Overview
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 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emmanuel Peprah, PhD
- Phone Number: 212-992-6085
- Email: ep91@nyu.edu
Study Contact Backup
- Name: Obiageli Nnodu
- Email: oennodu@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- SCD patients18 years older that have provided consent;
- Pediatric SCD patients aged 9 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Education
provision of information about task sharing
|
|
Experimental: TASSH
replicable evidence-based task-sharing strategy,TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH)
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient numbers - screening
Time Frame: 12 months
|
The number of patients taking HU identified through screening
|
12 months
|
Patient numbers - proportion on HU
Time Frame: 12 months
|
The proportion of patients that on HU based on the REACH Clinical Trial algorithm tailored for aged 9 months through adulthood using SPARCO HU Guidelines
|
12 months
|
Patient numbers - dosage
Time Frame: 12 months
|
Proportion of patients who maintained HU dosage
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mediators
Time Frame: 12 months and 24 months
|
Secondary outcome measures are the mediators of SIM adoption and sustainability across the clinical sites at 12 and 24 months.
The following measures will be used to assess the mediators of SIM via self-report.
The mediators are based on the constructs of the EPIS including inner context characteristics of the clinics, intervention characteristics, and implementation process measures
|
12 months and 24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U01HL168084 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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