Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversity of Washington
About this trial
The investigators will conduct a 3-arm individual-level RCT in Kisumu and Siaya, Kenya to compare perinatal outcomes associated with 3 models of STI testing and management in antenatal care. The investigators will enroll 3132 pregnant women and randomize 1:1:1 to receive standard-of-care (syndromic management only without CT, NG, or TV testing) vs. CT, NG, and TV testing using Xpert® assays universally vs. only among women without STI symptoms. All women with STIs detected and/or symptoms per Ministry of Health algorithms will receive immediate treatment, EPT per national guidelines, and tests of cure. All participants will be enrolled during routine antenatal care and followed through 9-months postpartum. The investigators will quantify and compare a composite outcome of pregnancy loss/stillbirth, PTB, LBW, SGA, and neonatal death, between randomization arms, in addition to several secondary and exploratory outcomes.
Eligibility criteria
Qualifiers
Self-identifying as a cisgender woman
Seeking antenatal services from the clinic
Planning to receive antenatal and postnatal care at the clinic
Willingness to receive syndromic STI screening and HIV/syphilis testing per national guidelines
Disqualifiers
Male gender
Not seeking antenatal services from the clinic
Not planning to receive antenatal and postnatal care at the clinic
Not willing to receive syndromic STI screening and HIV/syphilis testing per national guidelines
Trial design
Treatments tested in this trial
- Xpert® CT/NG and TV testing
Treatment groups
3,132 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Washington
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov