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Caregiver-completed pediatric survey was developed in 12 different languages, including new translated versions to ensure comparable measures.
Frontier Science, the Data Management Center for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, and QualityMetric, a 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 Phase I/II study will assess the safety, tolerability, acceptability, and pharmacokinetics of these medications in children living with HIV-1. The study will enroll up to 90 children between the ages of 2 and 12 worldwide over the next three years and is expected to begin enrolling this month.
To measure physical and emotional aspects of child health, CRAYON will utilize QualityMetric's SF-10 caregiver-completed pediatric survey in 12 different languages, including new translated versions for Setswana (spoken in Botswana), Luganda (Uganda), isiXhosa, isiZulu, Sesotho, and Afrikaans (South Africa). QualityMetric's translation process provided the new language options for the SF-10 be easily understood by caregivers and will produce comparable assessments of functional health across all participating research sites, as well as support IRB submission and translation validation.
"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. 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."
Reference: Frontier Science and QualityMetric Collaborate on Worldwide Treatment Study in Youth Living with HIV. BOSTON, May 31, 2023. PRNewswire.