Improving health outcomes for pregnant women in Kenya through STI testing
Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
This study is testing different ways of checking for STIs during pregnancy to see which method helps improve the health of mothers and their babies in Kenya.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3132 (estimated) |
| Sex | Female |
| Sponsor | University of Washington Academic / other |
| Locations | 8 sites (Homa Bay and 7 other locations) |
| Trial ID | NCT06203951 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of three different models of STI testing and management during antenatal care for pregnant women in Kisumu and Siaya, Kenya. A total of 3,132 participants will be randomly assigned to receive either standard-of-care management or enhanced STI testing using Xpert® assays, with follow-up through nine months postpartum. The study will assess various perinatal outcomes, including pregnancy loss, preterm birth, low birth weight, and neonatal death, to determine which testing model yields the best results for maternal and infant health.
Who should consider this trial
Good fit: Ideal candidates for this study are cisgender women who are seeking antenatal services and are willing to participate in STI screening and testing.
Not a fit: Patients who are not seeking antenatal care or who do not identify as cisgender women may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved perinatal outcomes for pregnant women by identifying and treating STIs more effectively.
How similar studies have performed: Previous studies have shown promising results with enhanced STI testing approaches in similar populations, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Homa Bay and 7 other locations
- Homa Bay Teaching and Referral Hospital — Homa Bay, Kenya (Recruiting)
- Rachuonyo South Sub County Hospital — Homa Bay, Kenya (Recruiting)
- Rangwe Sub County Hospital — Homa Bay, Kenya (Recruiting)
- Chulaimbo County hospital — Kisumu, Kenya (Recruiting)
- Kisumu County Hospital — Kisumu, Kenya (Recruiting)
- Lumumba Sub County hospital — Kisumu, Kenya (Recruiting)
- Migosi Sub County Hospital — Kisumu, Kenya (Recruiting)
- Yala sub County Hospital — Yala, Kenya (Recruiting)
Study contacts
- Principal investigator: Jillian Pintye, RN, MPH, PHD — University of Washington
- Study coordinator: Lauren Gomez
- Email: gomezL4@uw.edu
- Phone: 206-685-5044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.