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

NCT04446611 | Completed DMC

• 1 other identifier: R01AI149339
• Study Type: interventional
• Target: 2,247
• Locations: 1 country
• Sites: 1

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 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

Keywords

Sexually transmitted infection; Neisseria gonorrhoeae; Chlamydia trachomatis; Trichomonas vaginalis; Antenatal care; HIV/AIDS; Birth outcomes; South Africa; Vaginal microbiome; Pregnancy; Diagnostic testing

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse birth outcomes among study arms

  Adverse birth outcomes as defined by a composite measure of preterm birth (born alive before 370/7 weeks gestation) or low birth weight (less than 2500g) as recorded in the maternity case records

  Recorded within 2 weeks of delivery

Secondary Outcomes (6)

• Change in STI prevalence (a) between baseline visit and delivery within the experimental arms and (b) between the experimental and control arms by delivery.

  Between baseline (first antenatal visit <27 weeks' gestation) and delivery outcome (collected within 2 weeks post-delivery)

• Correlation between Bacterial vaginosis-associated vaginal community state types and clearance of Chlamydia infection

  Assessed through study completion

• Incidence of Preterm birth among study arms

  At delivery

• Incidence of Low birthweight infants among study arms

  Within 2 weeks post-delivery

• Incidence of STI in infants exposed to infection in their mothers

  STI testing in mother and infants within 2 weeks post-delivery to a maximum of 6 weeks post-delivery

Study Arms (3)

Test at 1st ANC + Test-of-Cure (Treatment 1)

EXPERIMENTAL

Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment

Diagnostic Test: First antenatal care + test-of-cure

Test at 1st ANC + 30-34 gestation (Treatment 2)

EXPERIMENTAL

Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation

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

Syndromic Management (Control)

NO INTERVENTION

Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.

Interventions

First antenatal care + test-of-cure DIAGNOSTIC_TEST

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.

Test at 1st ANC + Test-of-Cure (Treatment 1)

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

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.

Test at 1st ANC + 30-34 gestation (Treatment 2)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \) 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

Sponsors & Collaborators

• Foundation for Professional Development (Pty) Ltd: lead
• University of Southern California: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of Cape Town: collaborator
• University of Alabama at Birmingham: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator

Study Sites (1)

Buffalo City Metro

East London, Eastern Cape, 5217, South Africa

Location

Related Publications (1)

• Medina-Marino A, Cleary S, Muzny CA, Taylor C, Tamhane A, Ngwepe P, Bezuidenhout C, Facente SN, Mlisana K, Peters RPH, Klausner JD. Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial. Trials. 2022 May 24;23(1):441. doi: 10.1186/s13063-022-06400-y.

  PMID: 35610666 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Andrew Medina-Marino, PhD, MPH

  Foundation for Professional Development

  PRINCIPAL INVESTIGATOR

• Jeffrey Klausner, MD, MPH

  USC Keck School of Medicine - University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The allocation of study arm is concealed to study staff during randomization
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention will incorporate diagnostic testing using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection at first ANC (aim 1 and 2) with either a test-of-cure (arm 1) or 30 weeks repeat testing as follow-up (arm 2) compared to the standard of care (arm 3), i.e. syndromic management as per the South African guidelines. It is thus a 3-arm (1:1:1) control trial with additional components of vaginal microbiome analysis, economic evaluation and qualitative insights.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: June 25, 2020
• Study Start: March 29, 2021
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Access Criteria: Based on contractual agreement

Locations

ZA (1)