Human immunodeficiency virus self-testing (HIVST) can reduce barriers associated with conventional facility-based HIV testing, and since its introduction in 2012, more than 6.5 million HIVST kits have been distributed globally.^1,2 In 2018, South Africa integrated HIVST into its national HIV strategy as a way to expand testing beyond standard healthcare facilities to meet the UNAIDS 90-90-90 target.^3,4 These targets state that 90%, 81% and 73% of the total population should know their HIV status, be linked to antiretroviral treatment (ART) and experience viral suppression, respectively.⁵ Despite the benefits of HIVST, there are some gaps associated with its use, as it is hard to track and is only classified as tests for triage, which should not be considered diagnostic.⁶

Furthermore, South Africa does not have an appropriate system for users to self-report their results, or be linked to care, and this lack of reporting makes it difficult for public health stakeholders to conduct monitoring and evaluation on the uptake and effectiveness of HIVST, especially at the population level.⁷

Over the last decade, low- and middle-income countries have experienced an increase in mobile coverage and smartphone use, which has qualified the introduction of mobile health (mHealth) interventions in these regions.^8,9,10

There is a strong body of evidence supporting the use of mHealth interventions to enhance patient outcomes for a broad spectrum of health conditions, including HIV. In low-income settings specifically, different interventions have targeted various stages of the HIV care cascade, including text message campaigns, telephone hotlines and mobile applications (apps).^{6,11,12,13,14}

South Africa has been investigating the use of mHealth interventions to accompany HIVST for users to self-report their results, and in a recent study, 9.8% of participants self-reported their results by using an interactive voice response telephone hotline.¹⁵ Feasibility studies have also been done on the HIVSmart! app and the Aspect^TM app; both mobile apps guide self-testers through the testing and reporting process. These apps were both tested in a clinical setting, under the observation of healthcare workers (HCWs), and whilst both the apps reported high usability and acceptability, they did not investigate the reporting of results in a non-clinical setting as an outcome.^16,17,18,19

The Ithaka app (Aviro Health, Cape Town, South Africa) has been developed to close this gap by providing untrained HIVST users a mobile platform to self-report their HIVST results independent of a formal clinical setting, whilst also removing the potential for observational bias. The objective of this study was to investigate the use of Ithaka as an HIVST support tool for individuals, specifically the ability to report self-results outside a clinical environment.

To our knowledge, this is the first study in South Africa to evaluate the use of an mHealth app to self-report HIVST results as an outcome, independent of observation in a clinical setting. Previous feasibility studies have shown high acceptance of mHealth apps for the monitoring and evaluation of HIVSTs; however, they only evaluated usability in the presence of HCWs and did not evaluate any reporting outcomes through the app.^16,17,18,19

Similar to these previous studies, the Ithaka app showed high self-reported usability amongst those interviewed, whilst also confirming that participants under real-world conditions were willing and able to self-report their results via the app. The self-reporting of results by logged on participants through the Ithaka app was 22.4%, which is acceptable, considering that it is common for apps to lose up to 80% of their active users in the first week.²¹

Furthermore, the percentage of HIVST results reported through Ithaka was more than twice that of a previous tele-health intervention in South Africa, which only led to 9.8% of participants self-reporting.¹⁵

Despite this increase in self-reporting and high usability Likert scores, 43.1% of participants who received counselling (a proxy for completing the self-test) still did not self-report their HIVST results, which leaves opportunity for improvement. Although field testing of Ithaka followed a 3-month human-centred design (including personal and journey mapping) and a 2-week pilot testing, a percentage (12.2%) of surveyed participants did experience challenges with the Ithaka platform. This not only suggests that users may need more than a brief introduction from a peer educator but also suggests that the technology development phase requires several iterations with greater consideration for pragmatic value propositions and testing of varied content or messaging before inclusion. Going forward, focus group or follow-up interviews with participants who did not complete the app journey could be conducted to further identify areas of improvement that caused participants to cease activity on the app.

Similar to reports of other South African digital health interventions, for users to completely embrace Ithaka and realise its full use, marketing campaigns can be used to create awareness, followed by a more comprehensive onboarding to motivate users.²² Although practical reasons for stopping the use of the app, such as forgetting to log back in or not using the test yet, should be mitigated with text message reminders, which have been shown to improve the user responsiveness of other mHealth apps,^23,24,25 we did not find this in our study in which registered participants received reminder messages on day 1 and day 7. Some participants cited data costs and network issues as challenges to the app, and these are well-documented barriers for any mHealth app to enter into the South African market;^6,22 however, Ithaka was a reverse-billed online platform that removed the barrier of data costs. As a reverse-billed platform, any and all data costs for using the platform are paid for by the service provider (Ithaka), and the end-users do not incur any costs, nor do they use any of their own data whilst on the platform.

There may have been some confusion by study participants regarding the meaning of reverse-billing, and this beneficial feature should be sufficiently explained to users in the future, so they know that no costs are incurred on their end whilst using the platform.

In South Africa, there is currently no endorsed platform for users to self-report their HIVST results, or be linked to care following a positive test,⁶ which makes the monitoring and evaluation very ineffective for the government and associated public health stakeholders.⁷ This study has shown that as a proof-of-concept, HIVST users are willing and able to self-report their HIVST results via the Ithaka app, and this sharing of information on a national scale could greatly improve HIVST monitoring and evaluation.

Whilst this study focussed on self-testing, which directly addresses the gap between the first 90 and the 85% of HIV-positive South Africans who know their status, it does not address the country’s largest deficit, as only 71% of people who are eligible for ART are actively receiving treatment.²⁶ Ithaka could continue to increase active users by sending out reminders to encourage the self-reporting of results and keep users engaged by promoting linkage to care opportunities. To improve accessibility and usability, the Ithaka platform has since been extended to WhatsApp and to support blood-based tests. The Ithaka platform has also undergone a number of processes and content changes that were implemented as a way to continue improving on the HIVST reporting rate. In addition, extensions to the tool to support and confirm linkages to care and improve initiation and viral load suppression are currently undergoing piloting and development.

This study presented some limitations. Participants were recruited through existing HIVST distribution points, so individuals may have had previous exposure to HIVST studies, and potential study fatigue may have influenced their willingness to participate. Because of this exposure, participants may have a greater base-level background knowledge of HIVST than the general population. The Ithaka app was only available to individuals with mobile phones capable of running the current iteration of the app and does not include individuals who could not access the app because of different operating systems or memory capacity. Furthermore, a peer educator helped participants log into and register on the app, which may have influenced the ease of use and initial components of the cascade.

The use of only one HIVST kit means that these results also cannot be generalised across all HIVST kits.

Additionally, only 8.3% of participants self-reported an HIV-positive result, which is much lower than the national prevalence of 13.1%, and this may be because of a selection or reporting bias, where individuals who may be HIV positive did not participate or report their positive results. The views presented of the user experience responses may not represent the views of the study population as only participants who completed the app journey and answered all questions were included in the post-study survey results. The low completion rate for some of the survey questions represents a minority of the group and a larger minority in relation to the general population.

Lastly, the post-test survey was conducted via voice call, which may have attributed to this low completion rate.

Millions of HIVST kits have been distributed globally; however, there is currently no universally accepted platform for users to self-report their HIVST results, health behaviour and outcomes in line with the HIV care cascade. This study has shown that HIVST users outside the clinical setting were willing and able to self-report their results via the app. This could be used on a national level to improve the monitoring and reporting of HIVST programmes, leading to the optimisation of kit distribution, and targeted marketing and support. The use of an app introduces the possibility to promote and improve linkage to care, counselling and follow-up for newly tested HIV-positive users. This, together with exploring other popular channels for making digital services available such as WhatsApp, needs to be explored further to ultimately enable the development of an app that is user friendly, cost efficient and beneficial to HIV programmes.