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OpenTrials
Completed

NCT Number: NCT03979144

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.

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Key information

Conditions

Mass Screening

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assessoria Clinica / Bio-Manguinhos / Fiocruz

Rio de Janeiro, 21.040-360, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational study

Behavioral

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.

Primary outcomes

  1. Compliance with self-test execution

    Time frame: Day 1

    Percentage of participants who followed all the steps correctly

  2. Compliance with results interpretation

    Time frame: Day 1

    Percentage of participants who misinterpreted the test result

  3. Compliance with self-test result

    Time frame: Day 1

    Percentage of positive results interpreted as negative

  4. Compliance with self-test steps

    Time frame: Day 1

    Percentage of participants who made mistakes in each of the steps

Sponsors and collaborators

Lead sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2019
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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