Usability assessment of seven HIV self-test devices conducted with lay-users in Johannesburg, South Africa

Mohammed Majam; Laura Mazzola; Naleni Rhagnath; Samanta T Lalla-Edward; Raees Mahomed; Willem Daniel Francois Venter; Alex Emilio Fischer

doi:10.1371/journal.pone.0227198

Usability assessment of seven HIV self-test devices conducted with lay-users in Johannesburg, South Africa

PLoS One. 2020 Jan 14;15(1):e0227198. doi: 10.1371/journal.pone.0227198. eCollection 2020.

Authors

Mohammed Majam¹, Laura Mazzola², Naleni Rhagnath¹, Samanta T Lalla-Edward¹, Raees Mahomed¹, Willem Daniel Francois Venter¹, Alex Emilio Fischer¹

Affiliations

¹ Ezintsha, a sub-division of Wits Reproductive Health and HIV Institute, University of Witwatersrand, Johannesburg, Gauteng, South Africa.
² Halteres Associates, San Francisco, California, United States of America.

Abstract

Introduction: The first 90 of the 90-90-90 initiative introduced by the World Health Organization(WHO) in 2015 requires 90% of people with HIV be aware of their status by 2020. In South Africa, conventional facility-based testing had reached 84.9% in 2018; innovative new methods, like HIV self-testing(HIVST) may close the testing gap. This study aimed to determine the usability of seven HIVST kits among untrained South Africans.

Methods: This cross-sectional study of 1400 adults in Johannesburg evaluated the usability of five blood fingerstick and two oral fluid HIVSTs, using WHO prequalification criteria, from June 2016 to June 2018. Participants were handed one kit, with no further information about the device or test procedure, and asked to perform the test in front of an observer. The observer used product-specific semi-structured questionnaires organized into a composite usability index(UI) using a HIVST process checklist, a contrived results interpretation and a post-test interview that expanded on participant experiences with the device and instructions-of-use(IFU). Participants were not tested themselves, but provided with contrived results to interpret.

Results: The average UI was 92.8%(84.2%-97.6%); the major difficulty was obtaining and transferring the specimen. Participants correctly interpreted 96.1% of the non-reactive/negative, 97.0% of the reactive/positive, 98.0% of the invalid and 79.9% of the weak positive results. Almost all participants(97.0%) stated they would visit a clinic or seek treatment for positive results; with negative results, half(50.6%) stated they should re-test in the next three months while one-third(36.1%) said they should condomize. Nearly all found the devices easy to use(96.6%), the IFUSs easy to understand(97.9%) and felt confident using the test unassisted(95.9%) but suggested improvements to packaging/IFUs to further increase usability; 19.9% preferred clinic-based testing to HIVST.

Conclusion: The UI and interpretation of results was high and in-line with previous usability studies, suggesting that these kits are appropriate for use in the general, untrained and unsupervised public.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Cross-Sectional Studies
Female
HIV / isolation & purification*
HIV Infections / blood
HIV Infections / diagnosis*
HIV Infections / epidemiology
Humans
Male
Mass Screening / instrumentation
Reagent Kits, Diagnostic* / virology
Saliva / microbiology
South Africa / epidemiology
User-Computer Interface
Young Adult

Substances

Reagent Kits, Diagnostic

Grants and funding

MM, NR, LM, STLE, WDFV, AEF were awarded grant number OPP1132929 from the Bill and Melinda Gates Foundation (https://www.gatesfoundation.org/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Halteres Associates provided support in the form of salaries for author LM, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.