A Finger-Stick Whole-Blood HIV Self-Test as an HIV Screening Tool Adapted to the General Public

Abstract

BackgroundIn 2013, the French Health Authority approved the use of HIV self-tests in pharmacies for the general public. This screening tool will allow an increase in the number of screenings and a reduction in the delay between infection and diagnosis, thus reducing the risk of further infections. We previously compared 5 HIV-self test candidates (4 oral fluid and one whole blood) and demonstrated that the whole blood HIV test exhibited the optimal level of performance (sensitivity/specificity). We studied the practicability of an easy-to-use finger-stick whole blood HIV self-test “autotest VIH®”, when used in the general public.Methods and MaterialsThis multicenter cross-sectional study involved 411 participants from the Parisian region (AIDES and HF association) between April and July 2014 and was divided into 2 separate studies: one evaluating the capability of participants to obtain an interpretable result using only the information notice, and a second evaluating the interpretation of test results, using a provided chart.ResultsA total of 411 consenting participants, 264 in the first study and 147 in the second, were included. All participants were over 18 years of age. In the first study, 99.2% of the 264 participants correctly administered the auto-test, and 21.2% needed, upon their request, telephone assistance. Ninety-two percent of participants responded that the test was easy/very easy to perform, and 93.5% did not find any difficulty obtaining a sufficient good quantity of blood. In the second study, 98.1% of the 147 participants correctly interpreted the results. The reading/interpretation errors concerned the negative (2.1%) or the indeterminate (3.3%) auto-tests.ConclusionsThe success rate of handling and interpretation of this self-test is very satisfactory, demonstrating its potential for use by the general public and its utility to increase the number of opportunities to detect HIV patients.

HIV testing strategies outside of health care settings in the European Union (EU)/European Economic Area (EEA): a systematic review to inform European Centre for Disease Prevention and Control guidance

“…Of the 65 studies that introduced HIV testing, 56 studies utilized novel HIV testing technologies to improve testing uptake [18,19,[21][22][23][25][26][27]29,[31][32][33][34][35][36][37][38][39][41][42][43]46,47,[50][51][52]54,[58][59][60][61][62][64][65][66][67][68][69][72][73][74][75][76][77][78]81,83,84,[86][87][88][89]…”

“…The feasibility/acceptability of testing outside of health care settings was assessed by 48 studies (Table 3) [18,[20][21][22][23][24][27][28][29][31][32][33][34]36,37,40,[42][43][44][46][47][48]51,54,59,61,63,65,67,69,[71][72][73][74][75][76][77][78][79][80][81][82][83]85,87,90,93,97]. Overall, HIV testing was found to be acceptable to people offered testing across community (65-99%) [27,…”

“…The evidence gathered suggests that self-sampling at home is useful in reaching groups at higher risk of HIV infection, such as MSM and black African populations [43,46,47]. Selftesting was also considered highly acceptable (71-98%) [23,28,31,42,97] and easy to do (92-98%) [23,42,75,97] and the results easy to interpret (97-99%), [23,28,31,75] although there was evidence to suggest that acceptability may be dependent on test price and location. [79,80,82] Both self-sampling and self-testing reached a high proportion of people who had never previously tested for HIV (10-51%) [18,24,42,43,47,72,79,97].…”

New initiatives to develop self-testing for HIV

“…Reliable use of HIVST kits has been reported as highly variable in observed studies (25-99.2%) (18,44,45), though groups used in these studies are not necessarily reflective of those likely to need or use HIVST, which makes critical assessment of these results complex. However sensitivity and specificity estimates for HIVST when used by self-testers are high, though would appear to be higher for whole blood based HIVST compared to oral fluid based tests (96.2-100% compared to 80-100%) (46).…”

Preferences for oral fluid rapid HIV self-testing among social media-using young black, Hispanic, and white men-who-have-sex-with-men (YMSM): implications for future interventions

“…20 In addition to this commercially available oral fluid rapid HIV self-test, over-the-counter fingerstick blood sample rapid HIV self-tests are under consideration for home-based use, although they are not yet offered in the US. 21 …”