Tenofovir (local routes)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Sibeko (vaginal gel), 2011	South Africa Not specified.	HIV uninfected women between the ages of 18 and 40 were eligibly enrolled at one rural (Vulindlela) and one urban (eThekwini) clinic.	Women randomly assigned in tenofovir gel arm within 30 days of the screening visit and that become pregnant.	unexposed, sick Women randomly assigned in placebo arm within 30 days of the screening visit and that become pregnant.	22 / 31	Participants testing positive for pregnancy continued with monthly follow-up visits but study product was temporarily withheld.

Study	Country Study period	Case	Control	Sample size	Rmk