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Completed
NCT04446611
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)
Conditions: Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes, Vaginal Microbiome, Neisseria Gonorrhoeae, Chlamydia Trachomatis, Trichomonas Vaginalis, Antenatal Care, Pregnancy
Sex: Female
Healthy volunteers: Yes
Phase: NA
Enrollment: 2247
Sponsor: Foundation for Professional Development (Pty) Ltd
Location: Buffalo City Metro East London Eastern Cape
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 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
Eligibility Criteria
Inclusion Criteria for pregnant women:
1. Age≥18 years
2. Currently pregnant based on positive urine pregnancy test
3. Attending first ANC visit for current pregnancy
4. Gestational age \
Source: ClinicalTrials.gov (NCT04446611). StuddyBuddy aggregates publicly available trial information.