USABILITY STUDY OF A SELF-TEST PROTOTYPE FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) SCREENING

Abstract

Globally, about a third of young people are aware of HIV status, which is far below the 95% target of the United Nations General Assembly Special Session. Increasing access to and acceptance of the HIV test is critical to reducing the incidence of HIV and improving access to treatment and support for HIV-positive people. People aware of being HIV positive are less likely to be at risk, just as people who receive antiretroviral treatment (ART) and adhere to this treatment, are less likely to transmit the virus to others. These strategies are ways to help reduce the transmission of the virus and impact the epidemic of the disease. With the self-test for HIV, people can use FO to find out if they have the virus in a private and convenient environment, with the advantage of a quick result within 20 minutes or less. For those who present positive results, it is recommended to seek confirmatory tests in the health units, in addition to referral, as soon as possible, to the care, prevention and treatment services. This type of testing is a way of reaching a greater number of people without an HIV diagnosis, since it facilitates access to early diagnosis and creates a demand for HIV testing, making the test possible for people who face barriers to access health services. The main objective of this research was to evaluate the usability of an HIV self-test prototype developed from the TR DPP® HIV - 1/2 Oral Fluid from Bio-Manguinhos, in 112 research participants, following the recommendation of Technical Note No. 20 / 2016 / GEVIT / GGTPS / ANVISA. This is a study with a mixed method approach to assess the usability of a prototype of an HIV self-test among lay users. Data collection techniques will be based on observation through videos of lay users conducting self-testing without supervision, a qualitative checklist for the observation of the participant, pre-test and post-test interviews and the closing form. The errors perceived during the test by the research participants were identified and recorded in relation to the procedures described in the instructions for use, as well as a risk assessment through the classification as to the severity of the errors. Thus, among the 107 participants who completed the self-test, four participants (3.74%) got all the steps right. 103 participants (96.26%) made mistakes in one or more steps. 31 participants (29.0%) misinterpreted the test results. It was concluded that it will be necessary to use only one instruction for use, with bigger letters and more illustrations. In addition, it will be necessary to modify the support envelope to facilitate opening, as well as revising and changing the text, illustrations and support to promote the agreement between the information. Such modifications are being carried out as control measures to facilitate the handling of the self-test and the understanding of the instructions for use by users and to reduce risks (keywords: HIV self-test, rapid tests, immunodeficiency).