Tenofovir (local routes)

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Sibeko (vaginal gel) 2011	South Africa Not specified. randomized controlled trial	Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004 tenofovir gel trial, a phase IIb placebo-controlled, double-blind randomized clinical trial.	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.	early pregnancy	22 / 31	Participants testing positive for pregnancy continued with monthly follow-up visits but study product was temporarily withheld.
Sibeko (vaginal gel) 2011	South Africa Not specified. randomized controlled trial		Women were randomly assigned in equal proportions to one of two study arms.		early pregnancy	22 / 31

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;