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Preventing Congenital Syphilis

NCT02353117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60386

Last updated 2018-04-26

No results posted yet for this study

Summary

Nearly 1.5 million pregnant women are infected with syphilis each year, and it is estimated that half of them will have adverse birth outcomes. Congenital syphilis remains a major public health issue, despite the fact that maternal syphilis is easy to detect and treat. Multiple barriers impair the elimination of congenital syphilis. Syphilis is often stigmatized and of low priority, and even women attending prenatal care early are potentially facing multiple clinical barriers. The study objective is to use implementation research methods to evaluate a multifaceted intervention to increase the use of evidence-based clinical procedures to prevent congenital syphilis. The investigators will perform a facility-based, two-arm parallel cluster randomized implementation trial in the Democratic Republic of the Congo and Zambia. The intervention will be multifaceted, tailored by formative research, and include: opinion leaders, reminders, monitoring, and feedback; point-of-care rapid tests; and treatment kits to be used immediately if the rapid test is positive. Improving syphilis screening and treatment will be promoted as a key step toward improving the quality of all components of prenatal care.

Conditions

  • Congenital Syphilis

Interventions

BEHAVIORAL

Congenital Syphilis Intervention Group

Sponsors & Collaborators

  • Instituto de Efectividad Clinica y Sanitaria (IECS)

    collaborator UNKNOWN

  • Kinshasa School of Public Health

    collaborator OTHER

  • University of Zambia

    collaborator OTHER

  • Tulane University School of Public Health and Tropical Medicine

    lead OTHER

Principal Investigators

  • Pierre Buekens, MD, PhD · Tulane SPHTM

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-11
Primary Completion
2017-07-14
Completion
2018-02-28

Countries

  • United States
  • Argentina
  • Democratic Republic of the Congo
  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02353117 on ClinicalTrials.gov