Mass Screening Clinical Trial
Official title:
Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening
It concerns a study to evaluate the usability of an HIV self-test prototype developed from TR DPP® HIV - 1/2 Oral Fluid. The study followed the recommendations of Technical Note No. 20/2016 / GEVIT / GGTPS / ANVISA.
It concerns a study with a mixed method approach to evaluate the usability of a prototype of
HIV self-test among lay users. Data collection techniques were performed through observation
through videos of lay users conducting self-testing without supervision, a qualitative
checklist by participant observation, pre-test and post-test interviews, and closure form.
There was no randomization in this study.
The study was conducted by four clinical research sites, distributed in four different states
of Brazil in other to obtain a geographic representation: Unidade de Ensaios Clínicos para
Imunobiológicos (UECI) at Rio de Janeiro; Centro de Ciências da Saúde da Universidade Federal
da Paraíba (UFPB) at Paraíba, Faculdade de Medicina de Botucatu (UNESP) at São Paulo and
Centro de Ciências Biológicas e da Saúde da Universidade Estadual do Pará (UEPA) at Pará.
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