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Background: This study described the incidence of adverse pregnancy-foetal outcomes (APFOs) in Kenyan HIV-infected ART-naive pregnant women and examined the relationship between maternal HIV-immune reconstitution inflammatory response syndrome (IRIS)/related risk factors and APFOs. This prospective cohort study was carried out among 102 HIV-IRIS-exposed and 102 HIV-IRIS non-exposed pregnant women after initiating ART.

Methods: Both groups were enrolled from two hospitals in Nairobi County, Kenya in July 2019. Data were collected in a standard structured form, including maternal and demographic characteristics, HIV-IRIS status, HIV-IRIS related factors and their pregnancy outcomes. APFOs were assessed by maternal HIV-IRIS status and HIV-IRIS related factors using logistic regression analysis.

Results: The incidence of APFOs, over the entire period, in IRIS versus non-IRIS, was 26.47 …