Operationalizing implementation science frameworks to plan a hybrid effectiveness-implementation study of a digital health intervention.

Background: Evaluating implementation of digital health interventions (DHIs) in practice settings is complex, involving diverse users and multistep processes. Proactive planning can ensure desired implementation determinants and outcomes are captured for hybrid studies, but operational guidance for DHI studies is limited.

Methods: We planned a cluster randomized, type II hybrid effectiveness-implementation trial testing PositiveLinks, a smartphone application for HIV care, compared to usual care (n = 6 sites per arm), among HIV outpatient sites in the DC Cohort Longitudinal HIV Study in Washington, DC.

Evaluating outcomes of mother-infant pairs using dolutegravir for HIV treatment during pregnancy.

Objectives: Dolutegravir (DTG), a second-generation integrase inhibitor, is an effective treatment for HIV but its safety and efficacy are not well established in pregnancy. Here, we assess maternal and infant outcomes of mother-infant pairs using DTG-containing regimens during pregnancy.

Methods: We performed a retrospective cohort analysis of pregnant women with HIV on DTG from two urban clinics in the United States, 2015-2018.