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.

Study Overview

• Status: Completed
• Conditions: Mass Screening
• Intervention / Treatment: Behavioral: Observational study

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.

• Study Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 21.040-360
    • Assessoria Clinica / Bio-Manguinhos / Fiocruz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Investigators: Principal Investigator: Tatiana J Fernandes, DSD, MSc, Assessoria Clinica / Bio-Manguinhos / Fiocruz

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 19, 2018
• Primary Completion (ACTUAL): January 26, 2019
• Study Completion (ACTUAL): March 11, 2019

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (ACTUAL): June 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 5, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Usability; Prototype; HIV self-test
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: ASCLIN 003/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No