Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening

Conditions
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Mass Screening

Intervention / Treatment
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* Behavioral: Observational study


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Observational 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with self-test execution | Percentage of participants who followed all the steps correctly | Day 1 | 
| Compliance with results interpretation | Percentage of participants who misinterpreted the test result | Day 1 | 
| Compliance with self-test result | Percentage of positive results interpreted as negative | Day 1 | 
| Compliance with self-test steps | Percentage of participants who made mistakes in each of the steps | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Usability, HIV self-test, Prototype