Background: Expanding routine opt-out HIV testing to control HIV epidemic is beneficial for vulnerable persons and for the society. However, data are lacking on long-term survival and safety outcomes of those tested HIV-positive by routine opt-out versus non-routine (risk-based) HIV testing under the same treatment and health care. Methods: We analyzed the population-based HIV/AIDS registry and follow-up data under Taiwan National Health Insurance, comparing the clinical outcomes of those diagnosed by routine opt-out testing or risk-based testing. The main outcomes were HIV/AIDS-related mortality, non-HIV-related mortality, and 1-year suicidal/accidental mortality. We matched subjects by year of diagnosis, and adjusted for effects of age, sex, transmission routes, and socioeconomic status using regression models. Findings: This study included all 28,674 Taiwan citizens diagnosed with HIV infection during 1986-2014 (8,431 [29%] by routine opt-out testing, and 18,305 [64%] by risk-based testing), with verified follow-up data. Compared with risk-based testing, routine opt-out HIV testing was associated with a significantly lower likelihood of late diagnosis (adjusted odds ratio 0·20, 95% CI 0·18-0·23; p<0·001), and a significantly lower HIV/AIDS-related mortality (adjusted hazard ratio [aHR] 0·63, 95% CI 0·53-0·75; p<0·001). In addition, routine opt-out HIV testing was not associated with increased non-HIV-related death (aHR, 0·94, 95% CI 0·91-0·98; p=0·001) or suicidal/accidental mortality (aHR 0·80, 95% CI 0·43 -1·49; p=0·48) compared with risk-based HIV testing. Interpretation: Compared with risk-based HIV testing, routine opt-out HIV testing is safe, and associated with favorable clinical relevant outcomes, including early HIV diagnosis and lower HIV/AIDS-related mortality, among individuals who were tested HIV-positive under National Health Insurance. Funding Statement: This work was supported by Taiwan Ministry of Science and Technology (grants no. MOST-102-2628-B-002-037-MY2, MOST-104-2314-B-002-035-MY2, and MOST-106-2314-B-002-115-MY3) and Taiwan Centers for Disease Control (grants no. MOHW-106-CDC-JH-105030, MOHW107-CDC-CB-106040, and MOHW-108-CDC-YH-107030). Declaration of Interests: All authors have no competing interest to disclose. Ethics Approval Statement: The study procedure was approved by the Research Ethics Committee (REC) of National Taiwan University Hospital (Taipei, Taiwan) (#201711046RIND). The REC approved the exemption of informed consent since all personal information had been anonymized.
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