Highlighting and addressing barriers to widespread adaptation of HIV self-testing in the United States.

INTRODUCTION: HIV self-testing (HIVST), whereby an individual performs and interprets their own rapid screening test at home, is another tool to increase the proportion of at-risk individuals who know their status. Globally, HIVST has rapidly been adopted through global partnerships to ensure equitable access to tests in low- and middle-income countries (LMIC). AREA COVERED: This review discusses the regulatory burdens of HIV self-testing within the United States while examining the use of HIV self-tests on a global scale. While the United States only has one approved HIV self-test, numerous tests have been prequalified by the WHO. EXPERT OPINION: Despite the US Food and Drug Administration (FDA) clearance of the first and only self-test in 2012, there have been no other tests that have undergone FDA consideration due to regulatory barriers. This, in turn, has stifled market competition. Despite existing evidence that such programs are an innovative approach to testing hesitant or hard-to-reach populations, high individual test cost and bulky packaging make large-scale, mail-out, and HIV self-testing programs expensive. COVID-19 pandemic has accelerated the public demand for self-testing - HIV self-test programs should capitalize on this to increase the proportion of at-risk people who know their status and are linked to care to contribute to ending the HIV epidemic.

HIV oral self-screening test among HIV/STD/TB clinic attendees: A mixed-method pilot investigation examining merit for larger evaluation.

Background & objectives: Globally, several countries consider HIV self-test as an important element in the toolbox to end AIDS by 2030. Against this background, the present investigation was conducted to pilot test the performance of an indigenous HIV oral self-test (HIVOST) and explore its acceptability. The overall purpose was to examine if this kit could serve as a promising tool and merit future larger clinical evaluation. Methods: A concurrent mixed-method investigation was undertaken during March-October 2019. One hundred and thirty two consecutive HIV/sexually transmitted diseases/tuberculosis clinic attendees were invited for participation; of whom, 100 were enrolled, and among them, 40 provided consent for qualitative in-depth interviews. The HIVOST kit assessed for its performance served as the 'index test', which worked on the principle of lateral flow chromatography. The results of the HIVOST were interpreted independently by the study physicians and participants at 20 min. HIVOST kit performance was assessed against the HIV confirmatory blood test result based on the national algorithm (3 rapid test or 1 ELISA and 2 rapid test) serving as the 'reference'. Sensitivity, specificity, positive predictive value, negative predictive value and inter-rater agreement were estimated. The voices and concerns of the study participants were coded followed by identification of qualitative themes and ideas. Results: The sensitivity and specificity of the index test at the end of 20 min as interpreted by the participants were 83.3 per cent [95% confidence interval (CI): 69.8 to 92.5] and 98 per cent (95% CI: 89.4 to 99.5), respectively. Study physicians and participants independently interpreted HIVOST results with substantial inter-rater agreement (kappa value 0.88; 95% CI: 0.78-0.97). All HIVOST test strips were valid. Majority of the participants preferred saliva over blood for HIV self-test. 'Comfort', 'confidentiality' and 'convenience' were the perceived advantages of HIVOST. Some of the participants wished the package inserts contained 'how-to-do instructions in local languages', 'expiry date (if any)' and 'contact helpline number'. A few of them highlighted the need for a confirmatory HIV result following oral self-test. Concerns of the participants revolved around potential self-harm following HIVOST-positive result and safe disposal of kits. Interpretation & conclusions: Two major highlights of the present investigation are (i) high level of concordance in HIVOST results interpreted by participants and physicians, and (ii) encouraging level of acceptance of HIVOST. These findings and encouraging HIVOST performance statistics lend support towards large-scale clinical evaluation of this index test.