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

Mass Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979144
• Other study ID #: ASCLIN 003/2017
• Status: Completed
• Start date: June 19, 2018
• Est. completion date: March 11, 2019

Study information

• Verified date: June 2019
• Source: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: March 11, 2019
• Est. primary completion date: January 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Mass Screening

Intervention

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.

Locations

Country	Name	City	State
Brazil	Assessoria Clinica / Bio-Manguinhos / Fiocruz	Rio De Janeiro

Sponsors (1)

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

Country where clinical trial is conducted

Brazil, 

Outcome

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