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


Autoři: Mohammed Majam aff001;  Laura Mazzola aff002;  Naleni Rhagnath aff001;  Samanta T. Lalla-Edward aff001;  Raees Mahomed aff001;  Willem Daniel Francois Venter aff001;  Alex Emilio Fischer aff001
Působiště autorů: Ezintsha, a sub-division of Wits Reproductive Health and HIV Institute, University of Witwatersrand, Johannesburg, Gauteng, South Africa aff001;  Halteres Associates, San Francisco, California, United States of America aff002
Vyšlo v časopise: PLoS ONE 15(1)
Kategorie: Research Article
doi: 10.1371/journal.pone.0227198

Souhrn

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.

Klíčová slova:

Adolescents – Blood – Body fluids – Educational attainment – HIV – HIV diagnosis and management – Schools – South Africa


Zdroje

1. AIDS. Global AIDS Update. UNAIDS. 2017. http://www.unaids.org/en/resources/documents/2017/%202017_data_book.

2. Human Sciences Research Council. The Fifth South African National HIV Prevalence, Incidence, Behaviour and Communication Survey, 2017: HIV Impact Assessment Summary Report. 2018. http://www.hsrc.ac.za/uploads/pageContent/9234/SABSSMV_Impact_Assessment_Summary_ZA_ADS_cleared_PDFA4.pdf

3. Miller CM, Ketlhapile M, Rybasack-Smith H, Rosen S. Why are antiretroviral treatment patients lost to follow‐up? A qualitative study from South Africa. Tropical Medicine & International Health. 2010: Jun;15 Suppl 1:48–54.

4. Pai NP, Behlim T, Abrahams L, Vadnais C, Shivkumar S, Pillay S, et al. Will an unsupervised self-testing strategy for HIV work in health care workers of South Africa? A cross sectional pilot feasibility study. 2013: 8, e79772.

5. Pai NP, Sharma J, Shivkumar S, Pillay S, Vadnais C, Joseph L, et al. Supervised and unsupervised self-testing for HIV in high-and low-risk populations: a systematic review. PLoS Med. 2013;10:e1001414. doi: 10.1371/journal.pmed.1001414 23565066.

6. Johnson C, Kennedy C, Fonner V, et al. Examining the effects of HIV self‐testing compared to standard HIV testing services: a systematic review and meta‐ analysis. JAIS. 2017: 20 (1) https://doi.org/10.7448/IAS.20.1.21594.

7. Wong V, Johnson C, Cowan E, Rosenthal M, Peeling R, Miralles M, et al. HIV Self-Testing in Resource-Limited Settings: Regulatory and Policy Considerations. AIDS Behav. 2014: 18(Suppl 4): 415. https://doi.org/10.1007/s10461-014-0825-9.

8. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011; 365:493–505. doi: 10.1056/NEJMoa1105243 21767103

9. Figueroa C, Johnson C, Verster A, Baggaley R. Attitudes and Acceptability on HIV Self-testing Among Key Populations: A Literature Review. AIDS Behav. 2015: 19:1949. doi: 10.1007/s10461-015-1097-8 26054390

10. Makusha T, Knight L, Taegtmeyer M, Tulloch O, Davids A, Lim J, et al. HIV Self-Testing Could “Revolutionize Testing in South Africa, but It Has Got to Be Done Properly”: Perceptions of Key Stakeholders. PLoS ONE. 2015: 10(3): e0122783. https://doi.org/10.1371/journal.pone.0122783 25826655

11. World Health Organization. Guidelines on HIV self-testing and partner notification: supplement to consolidated guidelines on HIV testing services. WHO Press, Geneva. 2016.

12. Unitaid, World Health Organization. Market and technology landscape: HIV rapid diagnostic tests for self-testing, 4th edition. Geneva: Unitaid; 2018.

13. Richter M, Venter WD, Gray A. Enabling HIV self-testing in South Africa. Southern African Journal of Medicine. 2016: 13(4):186–187.

14. Indravudh P, Choko A, Corbett E. Scaling up HIV self-testing in sub-Saharan Africa: a review of technology, policy and evidence. Curr Opin Infect Dis. 2018: Feb; 31(1): 14–24. doi: 10.1097/QCO.0000000000000426 29232277

15. Choko AT, MacPherson P, Webb EL, Willey BA, Feasy H, Sambakunsi R, et al. Uptake, accuracy, safety, and linkage into care over two years of promoting annual self-testing for HIV in Blantyre, Malawi: a community-based prospective study. PLoS Med. 2015; 12: e1001873. doi: 10.1371/journal.pmed.1001873 26348035

16. Johnson C, Baggaley R, Forsythe S, van Rooyen H, Ford N, Mavedzenge SN, et al. Realizing the Potential for HIV Self-Testing. AIDS and Behavior. 2014: Jul;18 Suppl 4:S391–5. doi: 10.1007/s10461-014-0832-x 24986599

17. Kalibala S, Tun W, Cherutich P, Nganga A, Oweya E, Oluoch P. Factors associated with acceptability of HIV self-testing among health care workers in Kenya. AIDS and Behavior. 2014: 18 (Suppl. 4), S405–414.

18. World Health Organization. Number of countries adopting HIV self-testing policies rises sharply. 25 July 2017. https://www.who.int/hiv/mediacentre/news/hiv-self-testing-increases/en/

19. National Department of Health South Africa. National HIV Self Screening Guidelines 2018. Department of Health Republic of South Africa, Pretoria: 2018.

20. World Health Organization. Technical Specifications Series for submission to WHO Prequalification–Diagnostic Assessment: Human immunodeficiency virus (HIV) rapid diagnostic tests for professional use and/or self- testing. Geneva: World Health Organization. 2017.

21. Smith P, Wallace M, Bekker LG. Adolescents’ experience of a rapid HIV self‐testing device in youth‐friendly clinic settings in Cape Town South Africa: a cross‐sectional community based usability study. JIAS. 2016: 19 (1): doi: 10.7448/IAS.19.1.21111 28406597

22. Peck RB, Lim JM, van Rooyen H, Mukoma W, Chepuka L, Bansil P, et al. What Should the Ideal HIV Self-Test Look Like? A Usability Study of Test Prototypes in Unsupervised HIV Self-Testing in Kenya, Malawi, and South Africa. AIDS Behav. 2014: 18(Suppl 4): 422. https://doi.org/10.1007/s10461-014-0818-8.

23. Bwana P, Ochieng L & Mwau M. Performance and usability evaluation of the INSTI HIV self- test in Kenya for qualitative detection of antibodies to HIV. Plos One. 2018. https://doi.org/10.1371/journal.pone.0202491.

24. Gotsche C, Simwinga M, Muzumara A, et al. HIV self-testing in Zambia: User ability to follow the manufacturer’s instructions for use. 9th IAS Conference on HIV Science (IAS 2017). 23–26 July 2017. Paris, France.

25. Blood Products Advisory Committee. Final Advisory Committee Briefing Materials: Available for Public Release. OraQuick® In-Home HIV Test. Blood Products Advisory Committee Briefing Document; May 15, 2012.

26. Kortum P, Peres SC. Evaluation of Home Health Care Devices: Remote Usability Assessment. JMIR Hum Factors. 2015: Jan-Jun; 2(1): e10. doi: 10.2196/humanfactors.4570 27025664

27. Brooke J. SUS: A quick and dirty usability scale. Usability Eval. Ind. 1996; 189–194.

28. Gresenguet G, Longo DJ, Tonen-Wolyec S, Mbouma Bouassa RS, Belec L. Acceptability and Usability Evaluation of Finger-Stick Whole Blood HIV Self-Test as An HIV Screening Tool Adapted to The General Public in The Central African Republic. Open AIDS J. 2017; 11:101–118. doi: 10.2174/1874613601711010101 29290887

29. Lippman S, Gilmore H, Lane T, Radebe O, Chen YH, Mlotshwa N, et al. Ability to use oral fluid and fingerstick HIV self-testing (HIVST) among South African MSM. PLos ONE. 2018: 13(11): e0206849. https://doi.org/10.1371/journal.pone.0206849 30408055

30. Tek Ng O, Chow A, Lee V, Chen MIC, Win MK, Tan HH, et al. Accuracy and User-Acceptability of HIV Self-Testing Using an Oral Fluid-Based HIV Rapid Test. PLoS One. 2012: 7(9): e45168. doi: 10.1371/journal.pone.0045168 23028822


Článek vyšel v časopise

PLOS One


2020 Číslo 1