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

Completed

• Conditions: Mass Screening

• Registration Number: NCT03979144
• Lead Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

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.

Study Timeline

• Study Start: 2018-06-19
• Primary Completion: 2019-01-26
• Study Completion: 2019-03-11
• Study First Submitted: 2019-05-20
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-05
• Last Update Submitted: 2019-06-05
• Study First Posted: 2019-06-07
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance with self-test execution	Day 1	Percentage of participants who followed all the steps correctly
Compliance with results interpretation	Day 1	Percentage of participants who misinterpreted the test result
Compliance with self-test result	Day 1	Percentage of positive results interpreted as negative
Compliance with self-test steps	Day 1	Percentage of participants who made mistakes in each of the steps

Trial Locations

Locations (1)

Assessoria Clinica / Bio-Manguinhos / Fiocruz; 🇧🇷 Rio De Janeiro, Brazil