Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
University of Washington
3,132 participants
Jan 27, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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
- Able and willing to provide informed consent for participation
Exclusion Criteria5
- 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
- Not able or willing to provide informed consent for participation
Interventions
Participants randomized to universal STI testing will be offered Xpert® CT/NG and TV testing regardless of symptoms, and they will receive a standard syndromic STI assessment. Participants randomized to the asymptomatic only testing will be offered Xpert® CT/NG and TV testing if no signs or symptoms of CT, NG, or TV are identified during STI assessment. Participants assigned to receive Xpert® testing will be counseled on CT/NG/TV testing, including the benefits of testing even in the absence of symptoms to detect asymptomatic infections (as informed by pilot evaluation). If a client accepts Xpert® testing, she will be instructed by the study nurse on how to self-collect a vaginal swab.
Locations(8)
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NCT06203951