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.
Study Type
OBSERVATIONAL
Enrollment
113
This was an observational study of a medical device, through the usability assessment, for the registration of a self-test for the immunodeficiency virus (HIV) screening.
Assessoria Clinica / Bio-Manguinhos / Fiocruz
Rio de Janeiro, Brazil
Compliance with self-test execution
Percentage of participants who followed all the steps correctly
Time frame: Day 1
Compliance with results interpretation
Percentage of participants who misinterpreted the test result
Time frame: Day 1
Compliance with self-test result
Percentage of positive results interpreted as negative
Time frame: Day 1
Compliance with self-test steps
Percentage of participants who made mistakes in each of the steps
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.