Clinical Trials


Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes

Intervention Type: Diagnostic Test
Study Type: Interventional
Sponsors: National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Foundation for Professional Development (Pty) Ltd, Louisiana State University Health Sciences Center in New Orleans, University of Alabama at Birmingham, University of California, Los Angeles, University of Cape Town
Participants: 2500
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 reduce adverse birth outcomes. In turn it aims to evaluate the cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per sexually transmitted infection (STI) and disability-adjusted life-year (DALY) averted. Furthermore, this study will incorporate a vaginal microbiome sub-study aimed to investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women. Aim 1 and 2: The intervention includes diagnostic testing at a woman's first antenatal care visit using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection with either a test-of-cure three weeks post-treatment (arm 1) or a repeat test at 30-34 weeks gestation (arm 2) compared to the standard of care, i.e. syndromic management (arm 3). Aim 3: Case-control study to investigate role vaginal microbiome in STI treatment outcomes
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Buffalo City Metro
East London, South Africa
Andrew Medina-Marino, PhD, MPH
+27 43 726 7538
Jeffrey Klausner, MD, MPH
+1 310 557 2273
Sex: Female
Minimum Age: 18
Healthy Volunteers: Accepts Healthy Volunteers
Inclusion Criteria:
- 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
Relevant Conditions

Gonorrhea, HIV/AIDS, Trichomoniasis

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