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Only 20% of people with hepatitis C virus (HCV) know their status. In low-income countries diagnosis is under 10%. Self-testing for HCV antibodies (HCVST) could expand the coverage of HCV testing services. Currently, there are no stringent regulatory authority (SRA) approved HCVSTs, therefore lay-user usability of three prototype kits was assessed. This was a cross-sectional observational study conducted with 171 (CareStart n = 60, Bioline n = 52, First Response n = 59) participants. Participants were given one of the three HCVST kits with only instructions for use (IFU) and asked to perform the test in front of a professional trained in rapid diagnostic tests (RDT). Usability indices were calculated based on the correctness of performing each step of the product-specific process followed by contrived results interpretation and a post-test interview. The usability index was 93.9% for CareStart, 90.7% for Bioline and 94.9% for First Response. Most errors were on incorrect handwashing, sample collection and transfer to the test device. An average of 93.1% of contrived results were correctly interpreted, with most errors related to interpreting invalid results. Most participants (n = 167) stated they would visit a clinic after a positive result. With negative results, nearly half (28/60 (46.7%)) stated they should condomize, while just over two-thirds of participants that used Bioline (35/52 (67.3%)) and First Response (38/59 (64.4%)) said they should re-test. Most participants (n = 162) found the devices easy to use. Participants liked that self-testing was fast, private and convenient, however there were some confusion with IFU steps and pictures, finger-pricking with the lancet, collecting blood after the finger-prick, and transferring the sample/buffer. Prototype HCVST kits exhibit high usability and result interpretation by lay-users, and should be considered for SRA approval.

HIV self-testing (HIVST) has been introduced to supplement existing HIV testing methods to increase the number of people knowing their HIV status. Various HIVST kits have been developed; however, in many countries, their entry into the market is contingent on either being listed as World Health Organization (WHO) prequalified diagnostics/products or being approved by that country’s health device regulator or both. In this cross-sectional study, we evaluated the usability, sensitivity and specificity of HIVSTs, as directed by the WHO prequalification literature. A boxed, sealed HIVST kit was provided to enrolled lay users with no further instruction, who then performed the test under observation. For each HIVST, a product-specific semi-structured checklist was used to calculate a usability index, while the sensitivity and specificity of each HIVST were calculated by comparing the HIVST results to the ‘gold standard’ – fourth-generation ELISA laboratory blood test. The average usability index was 97.1% (95.9–97.8%), while the average sensitivity and specificity were 98.2% (96.8–99.3%) and 99.8% (99.4–100.0%), respectively. We also diagnosed 507 (15.1%) HIV-positive participants from the general population. The average usability index, sensitivity and specificity were all comparatively high, and these results corroborate previous usability and performance studies from other regions. These results suggest HIVSTs are appropriate for the South African market and can assist manufacturers with readying their devices for final WHO prequalification evaluation. Significance: This study has followed the WHO Technical Specification Series for the prequalification of HIV self-test devices, so the usability, sensitivity and specificity results may be used to inform the WHO prequalification process. The average usability index (97.1%), sensitivity (98.2%) and specificity (99.8%) were all very high, and these results support previous usability and performance studies from other regions, which suggest HIV self-tests are appropriate for WHO prequalification, and subsequently, the South African market. This study also diagnosed 507 (15.1%) HIV-positive participants from the general population – slightly higher than the national prevalence of 13.1%.

Background:Human immunodeficiency virus self-testing (HIVST) can reduce facility-based HIV testing barriers; however, no proven applications exist with widespread uptake for self-reporting or linkage to care. Mobile health (mHealth) applications (apps) have shown high usability and feasibility scores, so Ithaka was developed for South Africans to self-report HIVST results outside clinical settings. Objectives:This study investigated the use of Ithaka as a support tool for HIVST users, specifically the ability to self-report results. Method:This cross-sectional study was conducted from November 2018 to June 2019. At existing HIVST distribution sites, individuals were given HIVST kits and then invited to use Ithaka. Participants could test at home and report their results through the app anytime. Ithaka tracked when people logged-on, registered, received counselling and reported results. Post-study surveys on user experience were also conducted. Results:Of 751 participants, 531 (70.7%) logged onto the app, 412 (54.9%) registered, 295 (39.3%) received counselling and 168 (22.4%) self-reported results. Participants strongly agreed that Ithaka was useful and that it was easy to upload results. Forty-one participants completed a post-test survey, and 39/41 (95.1%) completed the app journey. Most participants (36/41;87.8%) had no challenges, although 2/41 (4.9%) cited perceived data costs, 2/41 (4.9%) difficulty uploading results and 1/41 (2.4%) language, as challenges. Conclusion:Despite the small sample size, this study has shown that HIVST participants under pragmatic conditions were willing and able to self-report results via the app, whilst also identifying areas of improvement for scaling up.

Background: Human immunodeficiency virus self-testing (HIVST) reduces barriers associated with facility-based testing; however, no formal mechanism exists for users to self-report results or link to care. The Aspect TM HIVST mobile application (app) was developed for use in South Africa. Objectives: This study evaluated the acceptability and feasibility of the Aspect TM HIVST app for individuals from the inner city of Johannesburg. Method: This cross-sectional pilot, with a convenience sample of 300 adults, was conducted in July 2018. Participants were provided an OraQuick HIVST kit and a smartphone preloaded with the app, then asked to follow the in-app instructions for use (IFU) to complete the HIVST and upload results. Trained healthcare workers (HCWs) observed and recorded any deviations from the IFU, and conducted a post-test survey to assess acceptability. Feasibility was evaluated by the number of participants who agreed to participate, completed the self-test, and uploaded all information onto the app correctly. Results: Most participants (98.7%) found the app easy to use. To reduce difficulties related to the IFU (26; 8.7%), participants suggested multimedia supplements (4; 1.3%), additional languages (4; 1.3%) and simplified instructions (5; 1.7%). All individuals approached, agreed to participate, 267 (89.0%) correctly completed all steps and 210 (78.7%) successfully captured all information on the app. Most errors (26; 8.7%) were testing errors and 1 (0.3%) was from the app sequence. Twelve (4.5%) errors were with test strip imaging and 72 (27.0%) discordances were with demographic information. Conclusion: Despite some challenges with IFU interpretation and data capture via the app, this pilot showed that the Aspect TM HIVST app is an acceptable way to upload mobile HIVST results and demographic information to a central database.

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.

The gap in HIV testing remains significant and new modalities such as HIV self-testing (HIVST) have been recommended to reach key and under-tested populations. In December 2016, the World Health Organization (WHO) released the Guidelines on HIV Self-Testing and Partner Notification: A Supplement to the Consolidated Guidelines on HIV Testing Services (HTS) and urged member countries to develop HIVST policy and regulatory frameworks. In South Africa, HIVST was included as a supplementary strategy in the National HIV Testing Services Policy in 2016, and recently, guidelines for HIVST were included in the South African National Strategic Plan for HIV, sexually transmitted infections and tuberculosis 2017–2022. This document serves as an additional guidance for the National HIV Testing Services Policy 2016, with specific focus on HIVST. It is intended for policy advocates, clinical and non-clinical HTS providers, health facility managers and healthcare providers in private and public health facilities, non-governmental, community-based and faith-based organisations involved in HTS and outreach, device manufacturers, workplace programmes and institutes of higher education.