Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes
Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness
About this trial
This is an interventional screening trial for Sexually Transmitted Infection focused on measuring Sexually transmitted infection, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Antenatal care, HIV/AIDS, Birth outcomes, South Africa, Vaginal microbiome, Pregnancy, Diagnostic testing
Eligibility Criteria
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
Sites / Locations
- Buffalo City MetroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
Test at 1st ANC + Test-of-Cure (Treatment 1)
Test at 1st ANC + 30-34 gestation (Treatment 2)
Syndromic Management (Control)
Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment
Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation
Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.