Evaluation of antimicrobial prophylaxis to prevent syphilis in pregnancy in patients at risk in Rio de Janeiro, Brazil

University Of California Los Angeles, Los Angeles CA

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT There has been a dramatic resurgence in the number of congenital syphilis cases globally, including a very steep rise in the number of cases in the U.S. In Brazil, congenital syphilis is an extremely serious health problem despite numerous campaigns aimed at targeting eradication of syphilis during pregnancy. In the last 10 years, the number of cases of syphilis in pregnancy in Rio de Janeiro has skyrocketed, with 1 to 2 of every 10 pregnant patients who receive prenatal care in disenfranchised areas of the city testing positive for syphilis. This is 2 logs higher than the already dramatic number of cases observed in the U.S. Rio de Janeiro currently has the highest number of syphilis pregnancy cases in the country. Our group of researchers has a longstanding collaboration in the field of infectious diseases, particularly vertical transmission of infections, which spans 3 decades, with landmark clinical trials conducted such as NICHD HPTN 040 for prevention of intrapartum transmission of HIV. The site in Brazil is a seasoned NICHD site with participation in many NIH-sponsored network studies since 1999, while the UCLA PI is a licensed physician in both the U.S. and Brazil, and a native of Rio de Janeiro. We propose to conduct a randomized clinical trial for prevention of maternal syphilis during pregnancy, utilizing the existing local health infrastructure and scientific methods developed in our prior studies, with the support of the Brazilian Ministry of Health and local health departments which welcome this partnership given the urgent need to address the ongoing syphilis crisis. The main goal of the proposed research is to prevent the development of syphilis in pregnancy and congenital syphilis through enhanced serologic screening for syphilis during prenatal care with point of care treponemal testing at 6, 7 and 8 months of pregnancy and monthly shots of benzathine penicillin as syphilis prophylaxis to negative participants in the intervention arm as compared to standard of care in pregnant patients randomized to the control arm (point of care testing three times during pregnancy). The study will assess the number of patients screening positive for syphilis and the number of infants requiring treatment for congenital syphilis in a study population comprised of 500 pregnant participants. Patients identified with syphilis will be managed according to Brazilian standard of care guidelines which mirror CDC recommendations. The study will assess tolerability, acceptability, and safety of benzathine penicillin while evaluating maternal/ obstetrical and infant health parameters during pregnancy and at the time of birth. The data rendered will be crucial for development of prevention efforts to curtail the syphilis epidemic.