Background

Across Western European countries (EU/EEA) the number of new HIV diagnoses has slightly declined between 2009 and 2018 (from 32,653 to 26,164), which is mostly driven by a substantial decline in a subset of countries [1]. These national declines are attributed to implementation of comprehensive combination prevention programmes in these countries. Despite this decline in new diagnosis, nearly half (48.6%) of new diagnoses in the EU/EEA in 2017 were made at a late stage of infection [2] indicating the need for easily accessible HIV testing options. Over the past decade there has been an expansion of HIV testing into non-clinical settings [3, 4] where in some countries, testing is offered by community health workers (CHW) and other testing technologies have also become available including HIV self-sampling and HIV self-testing [5, 6]. Both testing modalities have the benefit that users do not need to visit a clinic and can carry out the test at their own convenience. Self-sampling has become common in only a few countries as it relies on a reliable laboratory network [7]. Implementation of HIV self-tests (HIVST) is at varying stages in European countries. It is legal in 22 countries in Europe (69%) and 14 countries also have national policies that support its implementation. Overall, less than half (47%, 15/32) have introduced HIVST but uptake remains low [8].

The benefits and high acceptability of HIVST have been documented globally [9, 10] and it has been recommended by the WHO since 2016 [11]. There is however a lack of published studies on the acceptability and usability in the European context, particularly with regard to their use in real-life scenarios. Furthermore, as HIVST are often obtained through private companies and used anonymously, it has been difficult to monitor and evaluate their uptake, as well as to understand the contribution of HIVST in diagnosing people and the volume of users linked to appropriate services.

In Lithuania, new diagnoses rates remain low, but have risen over the past decade where two-thirds of people were diagnosed late in 2017 [2], indicating that HIV combination prevention measures require scaling up. The HIV epidemic is concentrated in people who inject drugs (PWID), men who have sex with men (MSM) and prisoners. HIV testing is available at clinics and large hospitals where key population groups, pregnant women and TB patients are all offered HIV testing. Community HIV testing is not common due to legal restrictions.

In Italy, the number of new diagnoses has declined by 26% between 2009 and 2018. But, in 2018 57% of people were diagnosed at a late stage of infection [12]. In 2019, there were an estimated 130,000 people living with HIV [13], of whom 86–91% were diagnosed [14], highlighting that further work is required to increase uptake of HIV testing. In 2019, most new diagnoses were in heterosexuals and MSM (42% respectively) and smaller proportion in PWIDs (6%) [15]. Testing is available at infectious disease units at hospitals and clinics for STIs. Community testing services are available in some cities but not yet widespread.

Both countries have HIVST included in their national HIV testing policies and HIVST was legalised and made available for private purchase in 2016. They are predominantly available in pharmacies at a similar price point in both countries (20–30€). There is anecdotal evidence that in Lithuania, HIVST have had limited uptake, there is low public awareness for their availability and they are hard to access. In Italy uptake has been higher, but during workshops related to INTEGRATE Joint Action [16], members of community non-governmental organisations (NGOs) expressed concerns that there is insufficient information to support an individual to carry out the test correctly and link to care in case of a reactive result.

Two separate surveys were used to assess the different stages of implementation and better understand barriers to the use of HIVST in Lithuania and Italy. In Lithuania the survey sought to understand awareness of, attitudes toward and barriers to the use of HIVST among the general public. The Italian survey aimed to investigate the experience of people using a HIVST for the first time, focusing on users’ feelings about performing the test, their ability to carry out the test correctly, whether they would be likely to use one again in the future and if so what support they would like.

Methods

Lithuania - acceptability

The survey was developed using questionnaires previously used and published in the literature that also aimed to assess acceptability of HIVST [17, 18]. The proposed questions were reviewed and tailored to fit the Lithuanian context where required. The survey was carried out in November 2019 through online survey and through face to face interviews. The inclusion criteria for participants were at least 18 years old and fluent in Lithuanian. Survey participants were recruited through social media channel used for communicating prevention messages and directly in person when they came to get tested for HIV at Demetra’s (an HIV NGO based in Lithuania) testing service. Participants were asked about their HIV risk,Footnote 1 testing history, knowledge of HIVST, preferences and any concerns relating to using an HIVST, willingness to pay and information they would like to accompany the test. Data from the online and paper-based responses were combined.

Italy - usability

Two complementary surveys were developed to assess the usability of HIVST by the general public. One survey was designed to be completed by individuals using an HIVST for the first time, to assess the experience and the need for additional support. The other survey was designed to be completed by an individual observing the tester, to verify that the tester could accurately complete all the required steps of the test. Participants were recruited through clients of two Italian NGOs: ARCIGAY and Fondazione LILA MILANO. Inclusion criteria for participants were at least 18 years old, fluent in Italian and never having used an HIVST before. The most common HIVST available in Italy are produced by Mylan and a limited number of HIVST were provided by the company for free for the purpose of this study. Eligible participants were asked to perform an HIVST under the supervision of a CHW. Both the users and CHWs completed their retrospective questionnaires after the HIVST was carried out.

Results from each survey were analysed and separate descriptive analyses were performed. All survey questions can be found in Appendix 1–3.

Results

Lithuania - acceptability

In total, 138 people completed the survey (122 men and 16 women) and nearly all were educated to at least high school level (136/138). HIV risk was assessed using questions about sexual history, history of HIV indicator conditions and engagement in needle sharing practices1. The majority reported at least one HIV risk factor (86%, 119/138), of whom most had tested for HIV in the past year (67%, 80/119). Awareness of HIVST was relatively high among survey participants, most knew you could test for HIV using a self-test (75%, 103/138) and the majority had tested for HIV before (83%, 114/138). Further to this, most respondents (74%, 102/138) said they would likely buy and use an HIVST in the future. When respondents were asked about their preferred mode of testing, 46% (63/138) people indicated their preference for using a blood test; 22% (31/138) would opt for an HIVST and 32% (44/138) were unsure. Most people (80%, 110/138) said they would trust the result of an HIVST and would know how to proceed in case of a reactive result (66%, 91/138). The top cited reasons respondents gave for using an HIVST in the future were privacy and confidentiality, (70%, 97/138) regardless of reporting HIV factors (Fig. 1). For those who reported an HIV risk factor, the second highest reason for using an HIVST was the quick result (63%, 74/119). While for those who did not report any risk factor, it was that HIVST does not require the tester to share their personal details (64%, 12/19). However, most people did not think that HIVST would be easy to use (63%, 87/138).

Fig. 1
figure 1

Reasons why participants would or would not use an HIV self-test in the future

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The most common cited barrier to the use of HIVST was the price of the test for both those who reported an HIV risk factor (60%, 71/119) and those who did not report one (53%, 10/19). Only 16% (17/105) of participants would be willing to pay more than 20€ for the test and 15% (21/138) were currently able to pay more than 20€ for the test. Further to this, 42% (58/138) were concerned about performing the test incorrectly and a third (36%, 50/138) were concerned about having nobody with whom to discuss the test result. Most participants would prefer to purchase an HIVST at a pharmacy (70%, 96/138) or online (61%, 84/138). The majority also would like be able to test for other infections at the same time (68%, 94/138) and to have the contact details for support services (67%, 93/138).

Italy - usability

In total, 28 people were observed using an HIVST for the first time. Most participants were men (57%, 18/28), heterosexual (61%, 17/28), all were educated to at least high school level and the average age was 36 years old. Two thirds (21/28) had tested for HIV before and a third (9/28) were not aware that you could test for HIV using a self-test.

Most participants were successfully able to complete the HIVST, and over a third of participants (12/28) said that it was easy or very easy. However, CHWs reported that just over a third (9/28) of participants failed at least one step when performing the HIVST or that they required assistance to complete the test. The most common difficulties reported were the collection of an adequate blood sample (7/28) and difficulties understanding how to activate the test (6/28). Further to this, CHWs reported that 10 users did not record the time while waiting for the test result (15–20 min are required). Only one participant said that it was very difficult to read the test result but the CHWs reported that five people could not read the test result without assistance (Fig. 2).

Fig. 2
figure 2

Ease of reading the test result, as reported by the participant and community health worker

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Nearly all participants reported that they thought the test was reliable (27/28) and most said that they were satisfied with their testing experience (20/28). For those who were not satisfied, most stated it was because they did not complete the test or that the instructions were difficult to understand. Most participants said they would likely use an HIVST in the future (20/28) and the main reported reasons to use an HIVST were: rapid result (68%, 19/28), no need for medical prescription (36%, 10/28) and privacy (21%, 6/28). Preference for future testing was split where nearly half (13/28) would prefer to take the test alone and the other half would prefer to take the test with the support of someone else (15/28).

The reasons reported by participants about why they would not use an HIVST in the future were: lack of counselling (50%, 14/28), worried about reading result alone (32%, 9/28) and cost (29%, 8/28). In terms of cost, nearly a fifth of participants would be willing to pay more than 20€ (5/28) and most would like to purchase the HIVST at a pharmacy (75%, 21/28). When using an HIVST in the future, participants would like to receive contact details to access: relevant NGOs (64%, 18/28), counselling (50%, 14/28), testing for other STIs (36%, 10/28).

Full breakdowns for the survey results are available in Appendix 4–6.

Discussion

This study sought to understand facilitators and barriers to the use of HIVST in Lithuania and Italy. In Lithuania, the survey demonstrated high acceptability and demand for HIVST and in Italy the survey demonstrated that most were satisfied with testing for HIV using a self-test. In both surveys, most participants knew you could test for HIV using a self-test. However, both surveys highlighted issues that may hinder the wide scale uptake of HIVST in the respective countries.

In the Lithuanian survey, most participants reported that they would likely use an HIVST in the future. However, preference for future testing was fairly evenly split between being tested by HCW, using a self-test or not sure. This highlights that HIVST should not be the only option available and individuals should be given a choice. Participants also cited concerns over the price of the test, which was the most common reason why they would not to choose an HIVST; in Lithuania only 15% of participants were willing to pay the current cost for an HIVST. This concern was also expressed by the Italian participants, which indicates the need to offer self-tests at the lowest possible price.

Lithuanian participants were concerned that they would not carry out the test correctly; these findings were also mirrored in Italy, where nevertheless most participants reported being satisfied with the experience. CHWs reported that one third of Italian participants failed one or more steps while carrying out the tests: some of them found it difficult to carry out the test as they did not understand the instructions provided in the leaflet, despite most having a high level of education. This corresponds with another study among people who had recently been diagnosed with HIV after having used an HIVST, where nearly 30% (4/14) had difficulties completing the test or had an indeterminate test result [19]. This indicates the need to provide thorough information on how to take the test and to ensure that it is tailored to the local country’s context. It is also crucial to provide self-test kits users with appropriate resources. In fact, both surveys found that participants would like information about how to obtain support from relevant organisations. These organisations could help by providing assistance while performing the test, post-test counseling and linkage to confirmatory testing in case of a reactive HIVST result. This has also been found in other studies where participants were concerned about not being able to access support if they had a reactive result [20]. Further to this, participants also wanted to test for other infections at the same time and the development of Hepatitis C virus self-test this could help increase uptake of HIVST.

In Italy, participants also reported difficulties in obtaining an adequate amount of blood to complete the test. Currently, in HIVST most commonly available in Italy, only one lancet is provided and if users fail to collect the right amount of blood (e.g. due to vasoconstriction), they would not be able to complete the test. This could be overcome by providing more lancets in the testing kits, to allow users to complete the fundamental step of blood collection. The benefit of collecting information from both the user and the CHW allows us to understand the experience by the user and whether the test was successfully completed.

In both countries, one of the most common reasons for wanting to use an HIVST in the future was privacy and confidentiality. In Lithuania, HIV is still strongly stigmatised and this may indicate a perceived difficulty in accessing confidential HIV testing; HIVST could help to offer an alternative way for individuals to test. This was also found in a study in England, indicating that HIVST benefits of privacy and confidentiality lower the barriers to testing and help to widen access for MSM and black and other minority ethnic groups [21]. In addition, in Lithuania only HCWs can carry out an HIV test and in Italy a HCW needs to be on site during testing activities [8]. HIVST could also help to remove the barrier of medicalised testing, widening access to key population groups.

Among the limitations, it must be noted that the sample size was small in both countries and participants were from a self-selected sample as they were using NGOs to access HIV testing, which may limit the generalisability of the findings to the wider public and this participation bias may not completely disclose the barriers of other individuals to have access to HIV testing. In Lithuania, most participants were either MSM or reported a risk factor for HIV; although this may bias our findings, these are two key population groups who could benefit from accessing HIVST. Information on HIV risk was not collected in the Italian survey, which could have helped in understanding if opinions about using of HIVST varied by HIV risk. These surveys, which are the first ones of their kind, clearly show the acceptability and feasibility of using HIVST as part of the HIV prevention response.

Conclusion

In both Italy and Lithuania, HIVST are available but have not yet been fully integrated into the national HIV prevention response. There is a paucity of data about the awareness and usability of HIVST. These two surveys aimed to understand the barriers to the full scale implementation of this testing strategy; in Lithuania it was found that HIVST has good acceptability and is a viable testing option; however, many would not be able to afford to pay for an HIVST at the current cost level. Access to HIVST in Lithuania needs to be widened and initiatives to reduce the cost of the test should be explored. In Italy, most participants reported that HIVST were easy to use; yet CHWs reported that some of them failed a step in the testing process, which could have resulted in a potential erroneous test result. Therefore, the current testing instructions need to be improved to help increase HIVST usability. The findings from both surveys will support the development of design of local testing strategies to increase awareness of HIVST, improve testing instructions and tailor support services for those using HIVST.