Mass Screening
Conditions
Keywords
Usability, HIV self-test, Prototype
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALObservational study
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.
Sponsors
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with self-test execution | Day 1 | Percentage of participants who followed all the steps correctly |
| Compliance with results interpretation | Day 1 | Percentage of participants who misinterpreted the test result |
| Compliance with self-test result | Day 1 | Percentage of positive results interpreted as negative |
| Compliance with self-test steps | Day 1 | Percentage of participants who made mistakes in each of the steps |
Countries
Brazil
Outcome results
None listed