BOSTON, May 31, 2023 /PRNewswire/ — Frontier Science, the Data Management Center for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, and QualityMetric, a leading global provider of patient-reported outcome (PRO) and clinical outcome assessment (COA) solutions, announced their collaboration on IMPAACT 2036/CRAYON: The Cabotegravir and Rilpivirine Long-Acting Injections in YOung ChildreN study. This critical study will assess the safety, tolerability, acceptability, and pharmacokinetics of these newly developed long-acting medications in children living with HIV-1. The study will enroll up to ninety children between the ages of 2 and 12 worldwide over the next three years.
To measure physical and emotional aspects of child health, CRAYON will utilize QualityMetric’s SF-10 caregiver-completed pediatric survey in twelve different languages, including new translated versions for Setswana (spoken in Botswana), Luganda (Uganda), isiXhosa, isiZulu, Sesotho, and Afrikaans (South Africa). QualityMetric’s translation process assures that the new language options for the SF-10 can be easily understood by caregivers and will produce comparable assessments of functional health across all participating research sites.
During the translation development, most languages required additional steps in the process because of language complexity or challenges with recruitment of translators and interview participants. To support IRB submission and study planning timelines, QualityMetric worked with a quick turnaround while still maintaining quality work to submit preliminary translations while the remaining validation work was undergoing.
“Our team was excited to assist with cultural, linguistic validation and support the study team in obtaining valuable feedback from participants by utilizing our high-quality surveys,” stated Angie Lee, Manager of Linguistics with QualityMetric.
With the inclusion of cognitive interview testing with local speakers of each new language, the translations underwent an extra measure of practical testing to confirm cultural relevance, comprehension, and validity.
Marlene Cooper, Director of the IMPAACT Data Management Center, stated “Frontier Science is enthusiastic to be partnered with QualityMetric in their support of the CRAYON study and the use of the SF-10 and appreciates their collaboration to meet the needs of the study.” K Rivet Amico, study team member from the University of Michigan, School of Public Health, noted that, “Being able to measure child mental and functional health confidently, with the same tool, for all participating study sites is a great advantage for global network trials like CRAYON.”
The CRAYON study is important to children and families living with HIV and aims to address the lack of simplified and potent pediatric antiretroviral therapy regimens for children. CRAYON is projected to start enrollment in June 2023.
The CRAYON study is funded and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH) of the National Institutes of Health (NIH) and implemented through the IMPAACT Network. The IMPAACT Network is funded by the NIH.
QualityMetric works with the world’s leading healthcare and life sciences companies to measure and better understand outcomes through the creation, administration, and review of general and patient-specific health surveys. Founded in 1997, QM combines its proprietary scientifically validated general health and disease specific surveys with its enabling technology, advanced analytics, and sector expertise to work with all the world’s largest pharmaceutical companies in clinical trials and patient surveillance. For more information, please visit: QualityMetric.com
ABOUT Frontier Science Foundation
Frontier Science is a not-for-profit corporation that has gained an international reputation as a highly capable data management and statistical organization, collaborating with research networks, pharmaceutical companies and others in the design, conduct and execution of clinical trials and long-term observation studies. Frontier Science’s mission is to collaborate with investigators and sponsors to conduct scientifically meaningful high-quality clinical trials, while advancing the application of statistical science and practice and data management techniques in science, health care and education. For more information, please visit: Frontierscience.org
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SOURCE Frontier Science Foundation; QualityMetric