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

NACompletedINTERVENTIONAL
Enrollment

2,247

Participants

Timeline

Start Date

March 29, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

February 28, 2025

Conditions
Sexually Transmitted InfectionHIV/AIDSCost-effectivenessBirth OutcomesVaginal MicrobiomeNeisseria GonorrhoeaeChlamydia TrachomatisTrichomonas VaginalisAntenatal CarePregnancy
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.

Trial Locations (1)

5217

Buffalo City Metro, East London

All Listed Sponsors
collaborator

University of Southern California

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

University of Cape Town

OTHER

collaborator

University of Alabama at Birmingham

OTHER

collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

lead

Foundation for Professional Development (Pty) Ltd

OTHER

NCT04446611 - Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile) | Biotech Hunter | Biotech Hunter