NCT06203951 Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
| NCT ID | NCT06203951 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Hiv |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,132 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,132 participants in total. It began in 2025-01-27 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jillian Pintye, RN, MPH, PHD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06203951 clinical trial?
This trial is open to female participants only, studying Hiv. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06203951 currently recruiting?
Yes, NCT06203951 is actively recruiting participants. Contact the research team at gomezL4@uw.edu for enrollment information.
Where is the NCT06203951 trial being conducted?
This trial is being conducted at Homa Bay, Kenya, Homa Bay, Kenya, Homa Bay, Kenya, Kisumu, Kenya and 4 additional locations.
Who is sponsoring the NCT06203951 clinical trial?
NCT06203951 is sponsored by University of Washington. The principal investigator is Jillian Pintye, RN, MPH, PHD at University of Washington. The trial plans to enroll 3,132 participants.
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