IAS 2017 IASconference Performance and usability of INSTI

#IAS 2017 | @IAS_conference Performance and usability of INSTI, a blood-based rapid HIV self test for qualitative detection of HIV antibodies in intended use populations in Kenya Matilu Mwau, M. D. , MTM, D. Phil(Oxon) mmwau@kemri. org

#IAS 2017 | @IAS_conference Kenya in 2015 Kenya 1. 5 million PLWHIV 5. 9% adult HIV prevalence Some counties >25% eg Homa Bay 78, 000 new infections 58% of infected adults are on ART 83% HIV+ unaware of partners’ status May, 2017, Pr. EP approved -“Be Self Sure” HIV self testing program

#IAS 2017 | @IAS_conference Study Objectives • Determine the performance and usability of the INSTI bloodbased HIV self test (bio. Lytical Laboratories, Richmond, BC, Canada) for an intended-use self test population in Kenya. – – Device performance Label comprehension Readability Results interpretation

#IAS 2017 | @IAS_conference INSTI HIV Self Test Key Features • Same platform as INSTI HIV-1/HIV-2 Ab Test • Blood-based • Use a 50 u. L free-flowing blood drop • fingerstick collection Sensitivity 100% • Specificity 99. 8% 4

#IAS 2017 | @IAS_conference INSTI Self Test Procedure (English and Swahili) Sample. Pour. 60 s 5

#IAS 2017 | @IAS_conference Study site and design • Site: Western Kenya (Busia County) – Matayos, Bumutiru, Khunyangu, Aterait and Asinge villages • Time: 22 nd Mar -11 Apr 2017 • 688 study participants – – 554 consented for fingerstick and venous blood draws 134 consented for fingerstick only 354 participated in the label comprehension (usability) study 91 subjects completed the results interpretation study 6

#IAS 2017 | @IAS_conference Accuracy (1) • 476 participants completed accuracy study – 201 known HIV positive. • Demographics, – > 18 years of age, – able to provide informed consent, – able to read, write and speak English/Swahili • Fingerstick blood used for observed self testing • Venous blood sent to KEMRI Lab for Bioelisa HIV-1+2 Ag/Ab kit (Biokit S. A, Barcelona, Spain) • INSTI HIV Self Test results produced by subjects • Self Test results interpreted and recorded by HCW 7

#IAS 2017 | @IAS_conference Accuracy (2) Subject HIV Status INSTI Negative Positive Total Negative 267 2 269 Positive 3 198 201 Invalid 0 6 6* Total 270 206 476 INSTI Sensitivity: 198/201 = 98. 5% (95. 7 -99. 5%) INSTI Specificity: 267/269 = 99. 26% (97. 3 -99. 8%) * Invalid results not used in the calculations 8

#IAS 2017 | @IAS_conference Usability Results (n=350) Observed IFU Element Subject Completed Correctly Preparation of fingerstick 346 (98. 9%) Correct use of lancet with no assistance 291 (83. 1%) Correct use of lancet with assistance 58 (16. 6%) Able to form “hanging” blood drop on finger with no assistance 348 (99. 4%) Able to easily get the blood drop to fall into INSTI sample diliuent 349 (99. 7%) Properly mixed and added sample diluent/blood to INSTI blotted membrane unit 349 (99. 7%) Correctly completed remaining INSTI test procedure 349 (99. 7%) 354 participants were recruited and 350 completed the survey-based usability, label comprehension and ease of use elements as observed and recorded by the health care staff 9

#IAS 2017 | @IAS_conference Acceptability (n=350) Questionnaire Item Responses Used the INSTI instructions for use to perform the test 343 (98. 0%) Found instructions easy to comprehend 339 (96. 9%) Considered the INSTI test easy to perform 330 (94. 3%) Found results interpretation easy to comprehend 342 (97. 7%) Indicated willingness to use INSTI again 342 (97. 7%) Would recommend INSTI to partner, family 344 (98. 3%) 10

#IAS 2017 | @IAS_conference INSTI Results Readability(n=91) INSTI Result Correct Interpretation (n=91) Strong Positive 91 (100%) Weak Positive 31 (34. 1%)* Negative 91 (100%) Invalid (no control spot) 91 (100%) * The remaining 65. 9% of subjects saw the weak spot but were unsure on how to interpret the result 11

#IAS 2017 | @IAS_conference Conclusions • INSTI PPV=89. 3%, INSTI NPV=99. 9% – Based on the performance of the INSTI HIV Self Test in this study – HIV prevalence in Kenya of 5. 9%: • • INSTI HIV Self Test device performance meets the Kenya Mo. H threshold. Overall label comprehension is high (96. 9%) – 57. 1% of participants had primary or no formal education. • In the usability study, more males (206) than females (142) took part – • likely due to the use of county administration and village events to mobilize participants Poor interpretation for the weak positive result – ? discordance in the IFU image between the English and Swahili versions. – The manufacturer has revised the IFU to provide more clear instructions on weak positive interpretation. 12

#IAS 2017 | @IAS_conference Acknowledgements Priska Bwana Lydia Ochieng Alupe HIV Lab KEMRI HQ HIV Lab 13