Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)

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

Conditions

• Sexually Transmitted Infection
• HIV/AIDS
• Cost-effectiveness
• Birth Outcomes
• Vaginal Microbiome
• Neisseria Gonorrhoeae
• Chlamydia Trachomatis
• Trichomonas Vaginalis
• Antenatal Care
• Pregnancy

Interventions

DIAGNOSTIC_TEST

First antenatal care + test-of-cure

Single point-in-time molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and infection-specific test-of-cure 3 weeks post-treatment. Women with a positive test-of-cure will be re-treated. As CT/NG is a combined Xpert test, women who present with an incident infection (newly diagnosed infection) will be treated and managed accordingly.

DIAGNOSTIC_TEST

First antenatal care + week 30-34 gestation (no test-of-cure)

Repeated molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and at week 30-34 gestation. No test-of-cure will be conducted for women with positive test results; however, additional treatment will be provided to women with persistent/recurrent vaginal discharge.

Sponsors & Collaborators

• University of Southern California

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of Cape Town

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Louisiana State University Health Sciences Center in New Orleans

  collaborator OTHER

• Foundation for Professional Development (Pty) Ltd

  lead OTHER

Principal Investigators

• Andrew Medina-Marino, PhD, MPH · Foundation for Professional Development

• Jeffrey Klausner, MD, MPH · USC Keck School of Medicine - University of Southern California

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-29

Primary Completion

2024-12-31

Completion

2025-02-28

Countries

• South Africa

Study Locations