Since its outbreak in December 2019 in Wuhan Province (China), the Coronavirus (COVID-19) disease quickly spread around the world in such a way that most response plans were outdated. There was an urgent need to change and adapt response strategies as the virus globally spread. Entire firms and economies were brought to a standstill in order to reduce the virus' capacity to spread and to limit some of the short-term impacts in order to save time and find out solutions to come back to a more or less normal way of life. Thus, most of the countries that closed their air, sea and land borders had to reopen them progressively, with travel restrictions submitted to rigid controls. In Côte d'Ivoire, as in all other countries, air travellers leaving the territory were required to provide a certificate for a negative COVID-19 test, valid for 24 to 72 hours depending on the country of destination. However, the national system implemented could not provide a result before 48 hours. The objective of this work was to develop an alternative strategy to the system for air travellers who were in a hurry and those who had a computer bug in ob-
Background: Thorough drug safety evaluation includes assessing potential impact of use on obstetric (OB) and infant outcomes. The MTN-016 study is the first pregnancy exposure registry for anti-HIV PrEP and microbicide agents. We evaluated OB and infant outcomes for registrants enrolled from third trimester TFV gel exposure studies. Methods: Data were restricted to registrants enrolled from studies with planned TFV vaginal gel exposure: MTN-002 (open label, single dose prior to cesarean) and MTN-008 (2:1 placebocontrolled, 7-day use). Registry study visits occurred before delivery when possible, and at < 1, 1, 6 and 12 months for infants. Infant malformation endpoints were determined by geneticists via independent review of physical exam (PE) and photo data. Results: All 16 MTN-002 and 90% (88/98) of MTN-008 mothers were registered, with 25% (n = 4) of MTN-002 and 97% (n = 86) of MTN-008 participants enrolling prior to known pregnancy outcome. Demographics were similar for MTN-008 enrollees and non-enrollees in the registry. Infant retention at 12 months was 88% (MTN-002) and 80% (MTN-008). One defect (ear canal) was noted in MTN-002, a rate (6%) comparable to the 3% US background rate for malformations (p = 0.51); no defects were noted in infants from MTN-008. Compared to placebo (n = 30), TFV gel (n = 58) was not associated with preterm delivery (1/58 (2%) vs. 2/30 (7%), p = 0.27), postpartum hemorrhage (11/58 (19%) vs. 3/30 (10%), p = 0.36), nonreassuring fetal status (3/58 (5%) vs. 1/30 (3%), p = 1.0), chorioamnionitis (1/58 (2%) vs. 2/30 (7%), p = 0.27), gestational diabetes (0/58 (0%) vs. 1/30 (3%), p = 0.34), or abnormal infant PE findings in the first year of life (14/58 (24%) vs. 8 (27%), p = 1.0).Conclusions: This first report from a novel pregnancy registry suggests third trimester TFV gel exposure is not associated with infant malformation or adverse OB or infant outcomes. Future HIV chemoprevention studies should include safety evaluation, including registry participation, for pregnant mothers and their infants.
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