Development of a usability study protocol for HIV Self-Testing kit for the licensing process in Thailand
DOI:
https://doi.org/10.14456/taj.2023.7Keywords:
HIV self-testing kit, usability study, HIV screening testAbstract
Thailand's Food and Drug Administration (FDA) has approved the HIV Self-Testing kit (HIVST kit) for home use since 2019. As part of the approval process, the Thai FDA requested a report on a usability study conducted among Thailand's population to demonstrate that the product's use and components, including the provided information for users, were designed adequately for Thai people. The goal of this study is to create and evaluate a protocol appropriate for the HIVST kit approval process. The protocol was divided into two parts: observation of untrained users and mock results interpretation. Four hundred volunteers used and interpreted the results of each HIVST kit from 5 different products. The results showed that the percentage of volunteers who met the acceptance criteria were 83.41% to98.25% for the observation of untrained user study, 93.75% to-97.75% for the mock results interpretation study, and 79.51% to 96.00% for the overall study. Out of the 5 HIV test kits, 4 of them provided results that met the specified criteria. The study results demonstrate the usability of the developed protocol, reflecting appropriate design for the use of the studied HIVST kit among Thai people. Additionally, these results can be submitted to the Thai FDA for the review of the HIVST kit’s performance in the licensing process.
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