Status:
COMPLETED
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
Lead Sponsor:
Foundation for Professional Development (Pty) Ltd
Collaborating Sponsors:
University of Southern California
National Institutes of Health (NIH)
Conditions:
Sexually Transmitted Infection
HIV/AIDS
Eligibility:
FEMALE
Phase:
NA
Brief Summary
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and red...
Detailed Description
Prevalence of STIs is high among pregnant women in South Africa and most infections remain untreated. Untreated infections impact on pregnancy and birth outcomes. Good diagnostic and point-of-care (PO...
Eligibility Criteria
Inclusion
- Inclusion Criteria for pregnant women:
- Age≥18 years
- Currently pregnant based on positive urine pregnancy test
- Attending first ANC visit for current pregnancy
- Gestational age \<20 weeks
- Agreeing to nurse-collected specimens
- Resident in Buffalo City Municipality (BCM)
- Intent to deliver in one of the four midwife obstetric units (MOUs) in BCM
- Gestational age will be confirmed via ultrasound
- Exclusion Criteria:
- Planning to relocate during pregnancy or deliver in an MOU outside of BCM
- Unknown HIV status (e.g. refusal, invalid test result)
- Currently participating in another ANC/HIV study
- When the ultrasound confirms ≥20 weeks gestation at first ANC
- Inclusion criteria for Neonates:
- 1\) born to mothers that provided informed consent to participate in study, 2) provision of updated verbal consent by mother to collect and test specimens for STIs
Exclusion
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
2247 Patients enrolled
Trial Details
Trial ID
NCT04446611
Start Date
March 29 2021
End Date
February 28 2025
Last Update
July 30 2025
Active Locations (1)
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1
Buffalo City Metro
East London, Eastern Cape, South Africa, 5217