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Feasibility and robustness of an oral HIV self-test in a rural community in South-Africa: An observational diagnostic study.


ABSTRACT: BACKGROUND:HIV-self-testing (HIVST) could be a strategy to get more people tested for HIV in resource limited settings. One of the prerequisites of a successful HIVST programme is the availability of an easy to use, valid HIV-test which is robust against field conditions and procedural errors by untrained lay users. METHODS AND FINDINGS:The primary objective of this study was to evaluate the ability of untrained persons to correctly interpret the OraQuick HIV Self-Test results with oral fluid compared with results obtained by trained users using the matched lot OraQuick Rapid HIV-1/2 Antibody Test and blinded to the results of the Self-Test. Sensitivity of the OraQuick HIV Self-Test in untrained users was 101 in 102 (99.02%; 95%CI = 93.88-99.95%)-and specificity- 1,241 in 1,241 (100.0%; 95%CI = 99.62-100.0%). Forty-eight Self-Tests were excluded in the accuracy analysis (due to a result read as invalid, not sure or ambiguous) resulting in a test system failure rate of 3.45% (95% CI 2.56%-4.55%). At least one observation of difficulty or error with one or more of the test steps were seen in 1,193 (84.6%) participants. Age, education and health literacy were independently associated with the sum score of procedural errors and difficulties. Four tests did not provide a valid result as determined by the trained user's interpretation of the Self-Test. CONCLUSIONS:The OraQuick HIV Self-Test provides reliable and repeatable results in a rural field environment in spite of procedural errors.

SUBMITTER: Deville W 

PROVIDER: S-EPMC6464222 | biostudies-other | 2019

REPOSITORIES: biostudies-other

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Feasibility and robustness of an oral HIV self-test in a rural community in South-Africa: An observational diagnostic study.

Devillé Walter W   Tempelman Hugo H  

PloS one 20190415 4


<h4>Background</h4>HIV-self-testing (HIVST) could be a strategy to get more people tested for HIV in resource limited settings. One of the prerequisites of a successful HIVST programme is the availability of an easy to use, valid HIV-test which is robust against field conditions and procedural errors by untrained lay users.<h4>Methods and findings</h4>The primary objective of this study was to evaluate the ability of untrained persons to correctly interpret the OraQuick HIV Self-Test results wit  ...[more]

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