The authors provide a brief overview of different propensity score methods that can be used in observational research studies that lack randomization. Under specific assumptions, these methods result in unbiased estimates of causal effects, but the different ways propensity scores are used may require different assumptions and result in estimated treatment effects that can have meaningfully different interpretations. The authors review these issues and consider their implications for studies of therapeutics for coronavirus disease 2019.
View Article and Find Full Text PDFSafer conception strategies can minimize HIV acquisition during periconception periods among women living in HIV-endemic areas. We examined uptake and predictors of persistent use of the same safer conception strategy among a cohort of HIV-uninfected South African women ages 18-35 years planning for pregnancy with a partner living with HIV or of unknown HIV-serostatus. The safer conception strategies we evaluated included oral PrEP, condomless sex limited to peak fertility, and waiting for a better time to have a child (until, for example, the risks of HIV acquisition are reduced and/or the individual is prepared to care for a child); persistence was defined as using the same safer conception strategy from the first visit through 9 months follow-up.
View Article and Find Full Text PDFPurpose: We describe constructs designed to protect the integrity of the results from comparative analyses using real-world data (RWD): staging and clean room.
Methods: Staging involves performing sequential preliminary analyses and evaluating the population size available and potential bias before conducting comparative analyses. A clean room involves restricted access to data and preliminary results, policies governing exploratory analyses and protocol deviations, and audit trail.
Background: Daily, oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) reduces HIV acquisition for African women. Adherence is key to efficacy and patterns of adherence can be highly variable in real-world settings. Using group-based trajectory modeling (GBTM), we sought to identify distinct patterns of periconception PrEP adherence and evaluate potential baseline predictors of such adherence trajectories.
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