Background: Oral HIV self-testing (HIVST) may be an attractive alternative to clinic-based testing, particularly for stigmatized and inaccessible populations. Available oral HIV self-test kits (OraQuick ADVANCE Rapid HIV-1/2 Antibody Test) have high sensitivity and specificity when used precisely as intended (93.6% and 99.9% respectively), but test performance may be worse if the sequence of testing steps are not correctly executed or results are misinterpreted. We evaluate whether female sex workers (FSW) in Kampala, Uganda can correctly use HIVST kits and interpret test results under potential real-world conditions where no pre-test training is available.
Methods: 104 FSW performed an oral HIVST without supervision under observation by a trained research assistant. Participants were given no pre-test training on kit use and had only the kit''s standard pictorial and written instructions to guide them. Study participants were asked to interpret a randomly drawn, anonymous, used oral HIV self-test kit. Self-read sensitivity and specificity were calculated in reference to the trained research assistants'' interpretation of the randomly drawn tests and adjusted for the kit''s sensitivity and specificity when used and interpreted as intended.
The majority of participants (61%) completed the necessary steps for an interpretable test result, but most (96%) struggled with the testing process in some way. Incorrect interpretation of test results was common: 23% of HIV-negative tests were interpreted as HIV-positive while 8% of HIV-positive tests were interpreted as HIV-negative, Figure 1. The self-interpreted real-world sensitivity and specificity were 67.9% (95% CI: 54.5-81.4%) and 67.7% (95% CI: 56.1-79.6%) respectively.

Figure 1 - AC Study
[Figure 1 - AC Study ]

Conclusions: In the absence of pre-test training, participants struggle with the oral HIV self-testing process and self-interpreted sensitivity and specificity is lower than expected. Training on HIVST kit use or improved self-test kit instructions may be necessary to avoid false positive and false negative test results.

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