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.

Inclusion Criteria:

• Individuals aged ≥ 18 years, of both sexes, who agree to participate in the study, after reading, understanding and signing the ICF;
• Individuals who authorized filming during the test.

Exclusion Criteria:

• Illiterates;
• Participants who have already performed any other HIV self-test;
• Health professionals with complete higher education;
• Colorblind individuals.

Lay people, that is, individuals without formal technical or scientific training, with different degrees of education, genres and age groups. The user profile included information about the academic / professional training and city / state, of both sexes, selected from characteristics distributed in 4 different groups, including regional variations:

Group 1: participants with a grade of schooling up to elementary school, in the age group of 18 to 29 years; Group 2: participants with a high school education level, between the ages of 18 and 29; Group 3: participants with educational level up to elementary school, in the age group from 30 years; Group 4: participants with a high school education, in the age group from 30 years of age