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

NCT03979144 | Completed DMC

• 1 other identifier: ASCLIN 003/2017
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Mass Screening

Keywords

Usability; HIV self-test; Prototype

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Illiterates;
• Participants who have already performed any other HIV self-test;
• Health professionals with complete higher education;
• Colorblind individuals.

Sponsors & Collaborators

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

Study Sites (1)

Assessoria Clinica / Bio-Manguinhos / Fiocruz

Rio de Janeiro, 21.040-360, Brazil

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Tatiana J Fernandes, DSD, MSc

  Assessoria Clinica / Bio-Manguinhos / Fiocruz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: June 7, 2019
• Study Start: June 19, 2018
• Primary Completion: January 26, 2019
• Study Completion: March 11, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)