Clinical trial NCT03979144: Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening
Official title: Usability Study of a Self-test Prototype for Human Immunodeficiency Virus (HIV) Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mass Screening
Keywords: Usability
HIV self-test
Prototype
Lead sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compliance with self-test execution
timeFrame: Day 1
measure: Compliance with results interpretation
timeFrame: Day 1
measure: Compliance with self-test result
timeFrame: Day 1
measure: Compliance with self-test steps
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Assessoria Clinica / Bio-Manguinhos / Fiocruz
Study officials:
affiliation: Assessoria Clinica / Bio-Manguinhos / Fiocruz
name: Tatiana J Fernandes, DSD, MSc
role: PRINCIPAL_INVESTIGATOR
References: