Improving hydroxyurea use for sickle cell disease in Nigeria
mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria
This study is testing a special training program for healthcare workers in Nigeria to see if it can help more people with sickle cell disease start using hydroxyurea treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 12 Months and up |
| Sex | All |
| Sponsor | New York University Academic / other |
| Locations | 1 site (Abuja) |
| Trial ID | NCT06318143 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the adoption of hydroxyurea (HU) therapy among sickle cell disease (SCD) patients in Nigeria, where current usage is less than 1%. It will utilize a cluster randomized controlled trial (RCT) to compare the effectiveness of a tailored training program for healthcare workers against standard educational information in promoting HU adoption. The study will also assess factors influencing the implementation and sustainability of this intervention across 20 clinical sites. By leveraging existing healthcare infrastructure, the research seeks to identify best practices for improving SCD management in resource-limited settings.
Who should consider this trial
Good fit: Ideal candidates include SCD patients aged 9 months and older who are not currently on hydroxyurea therapy and have provided informed consent.
Not a fit: Patients who are already receiving hydroxyurea therapy or are not registered in the electronic medical records database will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the adoption of hydroxyurea therapy, leading to improved health outcomes and reduced mortality for sickle cell disease patients in Nigeria.
How similar studies have performed: Other studies have shown success in improving treatment adoption through tailored interventions, suggesting potential for this approach in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) 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
Where this trial is running
Abuja
- University Of Abuja Teaching Hospital — Abuja, Nigeria (Recruiting)
Study contacts
- Study coordinator: Emmanuel Peprah, PhD
- Email: ep91@nyu.edu
- Phone: 212-992-6085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.