scholarly journals Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa

Diagnostics ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 1816
Author(s):  
Mohammed Majam ◽  
Naleni Rhagnath ◽  
Vanessa Msolomba ◽  
Leanne Singh ◽  
Michael S. Urdea ◽  
...  
Keyword(s):  
South Africa ◽  
Diagnostic Testing ◽  
Efficacy Analysis ◽  
Usability Assessment ◽  
Self Testing ◽  
Novice Users ◽  
Self Test ◽  
And Performance ◽  
Testing Algorithm ◽  
Hiv 1

The prevalence of HIV across South Africa places a strain on testing facilities. The use of HIV self-testing (HIVST) devices has been identified as a strategy to ease the burden on these facilities. The usability and performance of the Asante HIV−1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland OR, USA) device by novice users was assessed and reported on, to inform for the implementation of such devices in South Africa and elsewhere. Convenience sampling was used. Participants used the Asante HIVST device and recorded their interpretation of their results. Participants’ interpretations were compared with those of trained professionals and, thereafter, verified using the rapid diagnostic testing algorithm. Out of the eligible participants, 410 of the 524 (78.2%) were between the ages of 18–35. The usability assessment indicates that 100% of participants used the HIVST device’s information leaflet. However, 19/524 (3.6%) of participants who yielded an invalid result due to critical errors were excluded from the primary efficacy analysis. The average usability score was 98.1%. The sensitivity and specificity results were, 94.7% and 99.8%, respectively. This study shows that the Asante HIV self-test, and similar devices, can be valuable in providing convenient HIV self-testing and immediately available results. To accommodate a greater number of inexperienced users, the instructions may need to be revised.

scholarly journals A Study to Evaluate the Accuracy, Usability, and Acceptance of A Blood-Based HIV Self-Test Performed by Observed Intended Users in Canada

2020 ◽  
Author(s):  
Jason Lo Hog Tian ◽  
Richard A. Galli ◽  
Michelle Sumner-Williams ◽  
Kristin McBain ◽  
Emal Stanizai ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Cross Sectional ◽  
Efficacy Analysis ◽  
Percent Agreement ◽  
Self Testing ◽  
Simple Alternative ◽  
Self Test ◽  
Cross Sectional Design ◽  
Priority Populations ◽  
Health Canada

Abstract Background: Self-Testing for HIV (“HIVST”) is an emerging targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed especially in priority populations. The study objectives of this study were to (1) evaluate the INSTI HIV-Self-Test (HIV-ST) performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV-ST device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for license purposes.Methods: The study used a cross-sectional design and recruited consenting adults from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV-ST were compared with results of the Abbott Architect HIV Ag/Ab Combo test.Results: Primary efficacy analysis on 678 completed HIV-ST revealed a positive percent agreement of 100% and a negative percent agreement of 99.5% with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5%. Of the 708 participants who took part in the usability study, 92.4% of participants successfully performed the steps determined to be “critical” for successful completion of the test, 96.7% of participants found the instructions easy to follow, and 95% of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive) to 99.3% (for negative).Conclusions: The addition of this very first self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. An approved blood-based HIV self-test in Canada can offer an accurate, acceptable and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.

scholarly journals An HIV Diagnostic Testing Algorithm Using the cobas HIV-1/HIV-2 Qualitative Assay for HIV Type Differentiation and Confirmation

2021 ◽  
Author(s):  
Dana Duncan ◽  
John Duncan ◽  
Bastian Kramer ◽  
Alex Y. Nilsson ◽  
Betiel Haile ◽  
...  
Keyword(s):  
Diagnostic Testing ◽  
Diagnostic Algorithm ◽  
Nucleic Acid Amplification ◽  
Hiv Rna ◽  
Qualitative Test ◽  
Qualitative Assay ◽  
Testing Algorithms ◽  
Testing Algorithm ◽  
Positive Groups ◽  
Hiv 1

HIV-1 and HIV-2 diagnostic testing algorithms recommended by the Centers for Disease Control involve up to three tests and rely mostly on detection of viral antigen and host antibody responses. HIV-1 p24 antigen/HIV-1/2 antibody reactive specimens are confirmed with an immunochromatographic HIV-1/HIV-2 antibody differentiation assay and negative or indeterminate results from the differentiation assay are resolved by an HIV-1-specific nucleic acid amplification test (NAT). The performance of a proposed alternative algorithm using the cobas HIV-1/HIV-2 Qualitative NAT as the differentiation assay was evaluated in subjects known to be infected with HIV-1 (N=876) or HIV-2 (N=139), at low (N=6017) or high (N=1020) risk of HIV-1 infection, or at high-risk for HIV-2 infection (N=498) (Study A). The performance of the cobas HIV-1/HIV-2 Qualitative test was also evaluated by comparison to an HIV-1 or HIV-2 alternative NAT (Study B). The HIV-1 and HIV-2 overall percent agreements (OPA) in Study A ranged from 95%-100% in all groups. The positive percent agreements (PPA) for HIV-1 and HIV-2 were 100% (876/876) and 99.4% (167/168) respectively for known positive groups. The negative percent agreement in the HIV low-risk group was 100% for both HIV-1 and HIV-2. In Study B, the HIV-1 and HIV-2 OPA ranged from 99%-100% in all groups evaluated (N: 183 to 1030), and the PPA for HIV-1 and HIV-2 were 100% and 99.5% respectively for known positive groups. The cobas HIV-1/HIV-2 Qualitative Assay can discriminate between HIV-1 and HIV-2 based on HIV RNA, and can be included in an alternative diagnostic algorithm for HIV.

scholarly journals What Should the Ideal HIV Self-Test Look Like? A Usability Study of Test Prototypes in Unsupervised HIV Self-Testing in Kenya, Malawi, and South Africa

2014 ◽  
Vol 18 (S4) ◽  
pp. 422-432 ◽  
Author(s):  
Roger B. Peck ◽  
Jeanette M. Lim ◽  
Heidi van Rooyen ◽  
Wanjiru Mukoma ◽  
Lignet Chepuka ◽  
...  
Keyword(s):  
South Africa ◽  
Usability Study ◽  
Self Testing ◽  
Self Test ◽  
The Ideal

scholarly journals Usability assessment of seven HIV self-test devices conducted with lay-users in Johannesburg, South Africa

PLoS ONE ◽  
2020 ◽  
Vol 15 (1) ◽  
pp. e0227198 ◽  
Author(s):  
Mohammed Majam ◽  
Laura Mazzola ◽  
Naleni Rhagnath ◽  
Samanta T. Lalla-Edward ◽  
Raees Mahomed ◽  
...  
Keyword(s):  
South Africa ◽  
Usability Assessment ◽  
Self Test

Are women more likely to self-test? A short report from an acceptability study of the HIV self-testing kit in South Africa

AIDS Care ◽  
2016 ◽  
Vol 29 (3) ◽  
pp. 339-343 ◽  
Author(s):  
Alexandra Spyrelis ◽  
Saira Abdulla ◽  
Sasha Frade ◽  
Tessa Meyer ◽  
Miriam Mhazo ◽  
...  
Keyword(s):  
South Africa ◽  
Short Report ◽  
Self Testing ◽  
Self Test

scholarly journals The cost and intermediary cost-effectiveness of oral HIV self-test kit distribution across 11 distribution models in South Africa

2021 ◽  
Vol 6 (Suppl 4) ◽  
pp. e005019
Author(s):  
Katleho Matsimela ◽  
Linda Alinafe Sande ◽  
Cyprian Mostert ◽  
Mohammed Majam ◽  
Jane Phiri ◽  
...  
Keyword(s):  
South Africa ◽  
People Living With Hiv ◽  
Distribution Models ◽  
Integration Model ◽  
Sex Worker ◽  
Time And Motion ◽  
Self Testing ◽  
Test Kit ◽  
Self Test ◽  
The Cost

BackgroundCountries around the world seek innovative ways of closing their remaining gaps towards the target of 95% of people living with HIV (PLHIV) knowing their status by 2030. Offering kits allowing HIV self-testing (HIVST) in private might help close these gaps.MethodsWe analysed the cost, use and linkage to onward care of 11 HIVST kit distribution models alongside the Self-Testing AfRica Initiative’s distribution of 2.2 million HIVST kits in South Africa in 2018/2019. Outcomes were based on telephonic surveys of 4% of recipients; costs on a combination of micro-costing, time-and-motion and expenditure analysis. Costs were calculated from the provider perspective in 2019 US$, as incremental costs in integrated and full costs in standalone models.ResultsHIV positivity among kit recipients was 4%–23%, with most models achieving 5%–6%. Linkage to confirmatory testing and antiretroviral therapy (ART) initiation for those screening positive was 19%–78% and 2%–72% across models. Average costs per HIVST kit distributed varied between $4.87 (sex worker model) and $18.07 (mobile integration model), with differences largely driven by kit volumes. HIVST kit costs (at $2.88 per kit) and personnel costs were the largest cost items throughout. Average costs per outcome increased along the care cascade, with the sex worker network model being the most cost-effective model across metrics used (cost per kit distributed/recipient screening positive/confirmed positive/initiating ART). Cost per person confirmed positive for HIVST was higher than standard HIV testing.ConclusionHIV self-test distribution models in South Africa varied widely along four characteristics: distribution volume, HIV positivity, linkage to care and cost. Volume was highest in models that targeted public spaces with high footfall (flexible community, fixed point and transport hub distribution), followed by workplace models. Transport hub, workplace and sex worker models distributed kits in the least costly way. Distribution via index cases at facility as well as sex worker network distribution identified the highest number of PLHIV at lowest cost.

scholarly journals Performance of an Alternative Laboratory-Based HIV Diagnostic Testing Algorithm Using HIV-1 RNA Viral Load

2020 ◽  
Vol 47 ◽  
pp. S18-S25 ◽  
Author(s):  
Marc A. Pitasi ◽  
Shilpa N. Patel ◽  
Laura G. Wesolowski ◽  
Silvina Masciotra ◽  
Wei Luo ◽  
...  
Keyword(s):  
Viral Load ◽  
Diagnostic Testing ◽  
Testing Algorithm ◽  
Hiv 1

scholarly journals A Study to Evaluate the Accuracy, Usability, and Acceptance of a Blood-Based HIV Self-Test Performed by Observed Intended Users in Canada

2020 ◽  
Author(s):  
Richard A. Galli ◽  
Jason Lo Hog Tian ◽  
Michelle Sumner-Williams ◽  
Kristin McBain ◽  
Emal Stanizai ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Cross Sectional ◽  
Efficacy Analysis ◽  
Percent Agreement ◽  
Self Testing ◽  
Simple Alternative ◽  
Self Test ◽  
Cross Sectional Design ◽  
Priority Populations ◽  
Health Canada

Abstract Introduction: Self-Testing for HIV (“HIVST”) is an emerging targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed especially in priority populations. The study objectives of this study were to (1) evaluate the INSTI HIV-Self-Test (HIV-ST) performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV-ST device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for license purposes.Methods: The study used a cross-sectional design and recruited consenting adults from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV-ST were compared with results of the Abbott Architect HIV Ag/Ab Combo test. Results: Primary efficacy analysis on 678 completed HIV-ST revealed a positive percent agreement of 100% and a negative percent agreement of 99.5% with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5%. Of the 708 participants who took part in the usability study, 92.4% of participants successfully performed the steps determined to be “critical” for successful completion of the test, 96.7% of participants found the instructions easy to follow, and 95% of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive) to 99.3% (for negative).Conclusions: The addition of this very first self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. An approved blood-based HIV self-test in Canada can offer an accurate, acceptable and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.

scholarly journals Analytical Performance of the Exacto Test HIV Self-Test: A Cross-Sectional Field Study in the Democratic Republic of the Congo

2020 ◽  
Vol 7 (12) ◽  
Author(s):  
Serge Tonen-Wolyec ◽  
Jérémie Muwonga Masidi ◽  
Luc Ferdinand Kamanga Lukusa ◽  
Gaetan Nsiku Dikumbwa ◽  
Angèle Sarassoro ◽  
...  
Keyword(s):  
Field Study ◽  
Democratic Republic ◽  
Analytical Performance ◽  
Viable Option ◽  
Excellent Performance ◽  
Cross Sectional ◽  
Performance Sensitivity ◽  
Self Testing ◽  
Republic Of The Congo ◽  
Self Test

Abstract The Democratic Republic of the Congo (DRC) has begun implementing HIV self-testing to boost the first “95” of the UNAIDS 95-95-95 targets by 2025. This study aims to assess the performance and usability of the Exacto Test HIV (Biosynex, Strasbourg, France) self-test in the lab and in the field. The Exacto Test HIV self-test demonstrated high virological performance (sensitivity, 99.6%; specificity, 100%) in the lab and in the field in the hand of untrained users (sensitivity, 100%; specificity, 98.9%). Taken together, the excellent performance and usability characteristics of the Exacto Test HIV (Biosynex) self-test make the kit a viable option for HIV self-testing in the DRC.

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