Practicability and effectiveness of the unassisted HIV self-testing compared to the directly assisted HIV self-testing in the Democratic Republic of the Congo: A Randomized Implementation Trial
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Abstract Background. HIV self-testing (HIVST) may be use free or assisted by health care workers. The aim of this trial was to assess the practicability and effectiveness of unassisted HIVST (UH) versus directly assisted HIVST (DAH) in field settings in the Democratic Republic of the Congo (DRC). Methods. A non-inferiority evaluation using a blood-based HIV self-test was conducted in Kisangani, DRC. Participants were randomized in a 1:1 ratio to UH or DAH. Practicability was defined as the successful performance and the correct interpretation of the result. The linkage to care and the willingness to buy self-test constituted the outcome for HIVST effectiveness. Results. The rate of successful performance of the test was same (93.2%) in UH and DAH. The rate of correct interpretation of the results was 86.9% in UH versus 93.2% in DAH yielding the difference of -6.3% (95% CI: -10.8 to 2.5). UH significantly decreased the rate of correct interpretation of results as compared to DAH (aRR: 0.60 [95% CI: 0.36 to 0.98]; P=0.019). None significant difference was found between two arms in evaluating the linkage to care. Willingness to buy HIV self-test was higher in UH as compared to DAH (92.3% versus 74.1%; aRR: 4.20 [95% CI: 2.42 to 7.32]; P<0.001). Conclusion. This study demonstrates that both UH and DAH show high level of practicability and effectiveness for HIVST. However, additional support tools will be need to improve the practicability of the test in UH. Taken together, UH as well as DAH should improve access to HIV testing in DRC. Trial registration: PACTR201904546865585. Registered 03 April 2019 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=6032
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