Back to top

MTN-016 or EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) was an observational study and data registry designed to understand the effects, if any, the use of ARV-based HIV prevention products may have on pregnancy and infant outcomes. The study enrolled women who unintentionally became pregnant while participating in the MTN-003/VOICE, MTN-020/ASPIRE or MTN-025/HOPE studies (and then immediately stopped use of the study product), as well as their babies. Women and their babies from MTN-002 and MTN-008 were also included. In total, MTN-016 collected data on 460 women and 413 infants.  Among the study’s findings, researchers report no significant differences in pregnancy and infant outcomes between women in the ASPIRE study who were using the dapivirine ring at the time they became pregnant and women from the placebo group who became pregnant, supporting additional safety studies of the dapivirine ring throughout pregnancy. (See also MTN-042/DELIVER.)

MTN-016 Backgrounder



MTN-016 Q&A



See Also

MTN-016 Study Protocol


MTN-016 Study Page