Djamila L Ghafuri1, Brittany Covert Greene2, Bilya Musa3, Awwal Gambo3, Abdulrasheed Sani4, Shehu Abdullahi5, Binta J Wudil3, Halima Bello-Manga6, Safiya Gambo3, Matin Ghafuri2, Holly Cassell7, Kathleen Neville8, Fenella Kirkham9, Adetola A Kassim10, Muktar H Aliyu11, Michael R DeBaun2, Lori C Jordan12. 1. Vanderbilt-Meharry Sickle Cell Center for Excellence, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee; Division of Pediatric Neurology, Department of Pediatrics, Vanderbilt University of Medicine, Nashville, Tennessee. 2. Vanderbilt-Meharry Sickle Cell Center for Excellence, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee. 3. Department of Pediatrics, Murtala Mohammed Specialist Hospital, Kano, Nigeria. 4. Department of Pediatrics, Barau Dikko Teaching Hospital/Kaduna State University, Kaduna, Nigeria. 5. Department of Pediatrics, Bayero University/Aminu Kano Teaching Hospital, Kano, Nigeria. 6. Department of Hematology and Blood Transfusion, Barau Dikko Teaching Hospital/Kaduna State University, Kaduna, Nigeria. 7. Vanderbilt Institute for Global Health, Vanderbilt University Medical Center, Nashville, Tennessee. 8. Divisions of Pediatric Hematology-Oncology and Clinical Pharmacology and Toxicology, Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas. 9. Department of Pediatrics, University of Arkansas for Medical Sciences/Arkansas Children's Hospital, Little Rock, Arkansas. 10. Division of Hematology and Oncology, Department of Medicine, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee. 11. Health Policy, Vanderbilt Institute for Global Health, Vanderbilt University Medical Center, Nashville, Tennessee. 12. Division of Pediatric Neurology, Department of Pediatrics, Vanderbilt University of Medicine, Nashville, Tennessee. Electronic address: lori.jordan@vumc.org.
Abstract
BACKGROUND: Nigeria has the highest proportion of children with sickle cell anemia (SCA) globally; an estimated 150,000 infants with SCA are born annually. Primary stroke prevention in children with SCA must include Nigeria. We describe capacity-building strategies in conjunction with two National Institutes of Health-funded primary stroke prevention trials (a feasibility trial and phase III randomized controlled trial) with initial hydroxyurea treatment for children with SCA and abnormal transcranial Doppler (TCD) velocities in Nigeria. We anticipated challenges to conducting clinical trials in a low-resource setting with a local team that had not previously been involved in clinical research and sought a sustainable strategy for primary stroke prevention. METHODS: This is a descriptive, prospective study of challenges, solutions, and research teams in two trials that enrolled a total of 679 children with SCA. RESULTS: As part of the capacity-building component of the trials, over eight years, 23 research personnel (physicians, nurses, research coordinators, a statistician, and a pharmacist) completed a one-month research governance and ethics training program at Vanderbilt University Medical Center, USA. A lead research coordinator for each site completed the Society of Clinical Research Professionals certification. TCD machines were donated; radiologists and nonradiologists were trained and certified to perform TCD. A scalable E-prescription was implemented to track hydroxyurea treatment. We worked with regional government officials to support ongoing TCD-based screening and funding for hydroxyurea for children with SCA at a high risk of stroke. CONCLUSIONS: Our trials and capacity building demonstrate a sustainable strategy to initiate and maintain pediatric SCA primary stroke prevention programs in Africa.
BACKGROUND: Nigeria has the highest proportion of children with sickle cell anemia (SCA) globally; an estimated 150,000 infants with SCA are born annually. Primary stroke prevention in children with SCA must include Nigeria. We describe capacity-building strategies in conjunction with two National Institutes of Health-funded primary stroke prevention trials (a feasibility trial and phase III randomized controlled trial) with initial hydroxyurea treatment for children with SCA and abnormal transcranial Doppler (TCD) velocities in Nigeria. We anticipated challenges to conducting clinical trials in a low-resource setting with a local team that had not previously been involved in clinical research and sought a sustainable strategy for primary stroke prevention. METHODS: This is a descriptive, prospective study of challenges, solutions, and research teams in two trials that enrolled a total of 679 children with SCA. RESULTS: As part of the capacity-building component of the trials, over eight years, 23 research personnel (physicians, nurses, research coordinators, a statistician, and a pharmacist) completed a one-month research governance and ethics training program at Vanderbilt University Medical Center, USA. A lead research coordinator for each site completed the Society of Clinical Research Professionals certification. TCD machines were donated; radiologists and nonradiologists were trained and certified to perform TCD. A scalable E-prescription was implemented to track hydroxyurea treatment. We worked with regional government officials to support ongoing TCD-based screening and funding for hydroxyurea for children with SCA at a high risk of stroke. CONCLUSIONS: Our trials and capacity building demonstrate a sustainable strategy to initiate and maintain pediatric SCA primary stroke prevention programs in Africa.
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