Jared Baeten and colleagues published a prospective implementation study in PLOS Medicine last week on integrated delivery of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) with 1,013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda. The “Partners Demonstration Project” team enrolled couples with one HIV-positive partner and one uninfected partner and offered both of them antiretroviral medications and counseling for 6 months until the infected partner began ART. The idea was to prevent transmission through PrEP until the infected partner achieved viral suppression, at which point the risk becomes near zero for the uninfected partner.
This study appears to be a great example of well-planned and executed implementation science. The authors were interested in the feasibility, uptake, and adherence to a strategy with good science behind it. The piece I want to highlight here is probably the most boring: their statistical analysis plan. This is a solid example for students to follow. Table shells, diagrams, clear aims. Good stuff.