Sexually Transmitted Infections in Pregnancy Jeffrey Klausner, MD, MPH Professor of Medicine and Public Health Attending Physician Ronald Reagan Medical Center Division of Infectious Diseases: Global Health David Geffen School of Medicine Department of Epidemiology Karin and Jonathan Fielding School of Public Health IUSTI Marrakesh May
Disclosures Dr. Klausner is a faculty member of the University of California Los Angeles Dr. Klausner is a guest researcher with the US CDC Mycotics Diseases Branch Dr. Klausner is a member of the WHO STD Treatment Guidelines workgroup Dr. Klausner is a board member of YTH, Inc, non-profit Dr. Klausner is unpaid medical advisor for Healthvana In the past 12 months, Dr. Klausner and/or UCLA Regents has received: – Research funding, donated supplies or unrestricted gifts from the NIH, CDC, Hologic, Gilead Sciences, Cepheid, Standard Diagnostics, Alere, MedMira, bioLytical, AIDS Healthcare Foundation and Sentient Research – Advisory fees from Flora Biosciences, Roche, Black AIDS Institute, Social Scientific Systems
Many Sexually Transmitted Infections Disproportionally impact women Asymptomatic Only detected through screening Not vaccine preventable
Preterm birth is common Major cause of perinatal mortality Poor health outcomes High costs of newborn care 4
76% attributable risk percent of NG and preterm birth Belgium
Gonococcal opthalmia neonatorum Untreated maternal gonorrhea may cause blindness in newborn
Chlamydia trachomatis and preterm labor 7
Chlamydia trachomatis Ophthalmia neonatorum Respiratory disease, pneumonia
T. Vaginalis and Preterm Birth
STIs in pregnant women are common Davey-Jones, STD in press
Cadernos de Saude Publica, 2016, in press. Prof. Mariangela Freitas da Silveira Chlamydia trachomatis positivity, Pelotas, Brazil
New Laboratory Diagnosis of STIs
Point-of-care PCR for CT/NG Vaginal swabs, endocervical/urethral swabs and urine with closed extraction system Large sample volume combined with novel fluidics protocol maximizes sensitivity PCR carried out inside the cartridge New controls for specimen adequacy GeneXpert® CT/NG
No Requirement for dedicated PCR area 4 Results in ~ 1 hr POC, random access 3. Binding reagent into port 1 Xpert CT/NG US FDA-cleared in 2012
Platform Design GX-1 GX-16 GeneXpert Infinity-48 GeneXpert ® Module GX-2GX-4 Warren Johnson Laboratory, Port-au-Prince, Haiti
N=300 13% 26%
Prevention of STI-related Complications In Pregnancy
Prior Work: CT Screening Pilot Study 2 large urban hospitals in Lima, Peru Instituto Nacional Materno Perinatal (INMP) Hospital Nacional Arzobispo Loayza (HNAL) Cabeza J, et al, CDC STD 2014; STI Journal, in review
Chlamydia Study Implementation Flowchart Pregnant woman informed about study Pregnant woman informed about study Participant Screening/eligibility confirmation Informed consent Chlamydia screening: Self collected vaginal swab Participant Screening/eligibility confirmation Informed consent Chlamydia screening: Self collected vaginal swab Questionnaire Telephone contact of patients with positive result and appointment for treatment (patient and partner) Patient treatment Partner treatment Appointment for test of cure Patient treatment Partner treatment Appointment for test of cure Test of cure: Self collected vaginal swab
Hologic APTIMA DTS 400 Chlamydia trachomatis nucleic acid amplification test
High Acceptability and Feasibility, Peru High Acceptability: 93.5% (603 enrolled / 646 approached) Reasons refused (n=43): No time, afraid of test, unaccompanied minor
STI Prevalence and Demographics, Peru Chlamydia trachomatis: 10% (60 /600) Average age: 27.2 years Average gestational age: 26.3 weeks Cabeza J, et al, STI, 2015
Excellent Treatment Outcomes, Peru 60 patients contacted: 59/60 (98%) treated Partner treatment Methods: Patient-delivered 34 (56%) Concomitant DOT 21 (35%) No partner 4 ( 7%) No Treatment 1 ( 2%)
Prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis (n=300) was moderate
India
N=420
Ongoing STI screening in pregnancy projects Kinshasa, Democratic Republic of Congo Pretoria, South Africa Hanoi, Vietnam
Summary Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis are common and under-recognized maternal infections that few countries address Research is urgently need to demonstrate to policy makers the benefits of routine screening and treatment of STIs in pregnancy We have the tools, let’s realize the potential to save lives at birth 35
Thank you Supported in part by US NIH, CDC, Cepheid, Hologic and UCLA Team Klausner Saving Lives