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Background: South Africa maintains an integrated health system where syndromic management of sexually transmitted infections (STI) is the standard of care. An estimated 2 million cases of Neisseria gonorrhoeae (N. gonorrhoeae) occur in South Africa every year. Point-of-care diagnostic tests (POCT) may address existing STI control limitations such as overtreatment and missed cases. Subsequently, a rapid lateral flow assay with fluorescence-based detection (NG-LFA) with a prototype reader was developed for N. gonorrhoeae detection showing excellent performance and high usability; however, a better understanding is needed for device implementation and integration into clinics., Methods: A qualitative, time-series assessment using 66 in-depth interviews was conducted among 25 trained healthcare workers involved in the implementation of the NG-LFA. Findings were informed by the Normalization Process Theory (NPT) as per relevant contextual (strategic intentions, adaptive execution, and negotiation capacity) and procedural constructs (coherence, cognitive participation, collective action, reflexive monitoring) to examine device implementation within primary healthcare levels. Interviews were audio-recorded, transcribed, and then analyzed using a thematic approach guided by NPT to interpret results., Results: Overall, healthcare workers agreed that STI POCT could guide better STI clinical decision-making, with consideration for clinic integration such as space constraints, patient flow, and workload. Perceived NG-LFA benefits included enhanced patient receptivity and STI knowledge. Further, healthcare workers reflected on the suitability of the NG-LFA given current limitations with integrated primary care. Recommendations included sufficient STI education, and appropriate departments for first points of entry for STI screening., Conclusions: The collective action and participation by healthcare workers in the implementation of the NG-LFA revealed adaptive execution within the current facility environment including team compositions, facility-staff receptivity, and STI management experiences. User experiences support future clinic service integration, highlighting the importance of further assessing patient-provider communication for STI care, organizational readiness, and identification of relevant departments for STI screening., (© 2024. The Author(s).)

Accurate and user-friendly rapid point-of-care diagnostic tests (POCT) are needed to optimize treatment of Neisseria gonorrhoeae, especially in low-resource settings where syndromic management is the standard of care for sexually transmitted infections. This study aimed to assess the acceptability and usability of a novel lateral flow assay and portable reader for the point-of-care detection of N. gonorrhoeae infection (NG-LFA). This mixed-methods study was conducted as part of a diagnostic performance and usability evaluation of a prototype NG-LFA for detection of N. gonorrhoeae in symptomatic men and women at primary healthcare facilities in the Buffalo City Metro, South Africa. The Standardized System Usability Scale (SUS) was administered, and in-depth interviews were conducted among healthcare professionals (HCPs) and fieldworkers (FWs) at pre-implementation, initial use and 3- and 6-month study implementation to assess user expectations, practical experience, and future implementation considerations for the NG-LFA. Data collection and analysis was guided by the Health Technology Adoption Framework, including new health technology attributes, learnability, satisfaction, and suitability. The framework was adapted to include perceived durability. A total of 21 HCPs and FWs were trained on the NG-LFA use. SUS scores showed good to excellent acceptability ranging from 78.8-90.6 mean scores between HCPs and FWs across study time points. All transcripts were coded using Dedoose and qualitative findings were organized by learnability, satisfaction, suitability, and durability domains. Usability themes are described for each time point. Initial insecurity dissipated and specimen processing dexterity with novel POCT technology was perfected over time especially amongst FWs through practical learning and easy-to-use instructions (learnability). Participants experienced both positive and negative test results, yielding perceived accuracy and minimal testing challenges overall (satisfaction). By 3- and 6-month use, both HCPs and FWs found the NG-LFA convenient to use in primary health care facilities often faced with space constraints and outlined perceived benefits for patients (suitability and durability). Findings show that the NG-LFA device is acceptable and usable even amongst paraprofessionals. High SUS scores and qualitative findings demonstrate high learnability, ease-of-use and suitability that provide valuable information for first-step scale-up requirements at primary healthcare level. Minor prototype adjustments would enhance robustness and durability aspects., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 de Vos et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

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., Competing Interests: All test kits used during the assessment were provided at no cost to the study team by the manufacturer. Manufacturers provided input into study design, however all testing and analysis was done independently of device manufacturers. FV and MM are both members of the WHO HIVST Technical Working Group. Halteres Associates was commercially affiliated with the publication by providing salary for LM. This does not alter our adherence to PLOS ONE policies on sharing data and materials.