NCT02353117: PCS

Preventing Congenital Syphilis

Completed NA Last updated 26 April 2018

What this trial tests

NA trial testing Congenital Syphilis Intervention Group in Congenital Syphilis in 60,386 participants. Completed in 28 February 2018.

Timeline

11 January 2016

Primary endpoint
14 July 2017

28 February 2018

Quick facts

Lead sponsor	Tulane University School of Public Health and Tropical Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60,386
Start date	11 January 2016
Primary completion	14 July 2017
Estimated completion	28 February 2018
Sites	4 locations across Argentina, United States, Democratic Republic of the Congo, Zambia

Drugs / interventions tested

• Congenital Syphilis Intervention Group

Conditions studied

• Congenital Syphilis — all drugs for Congenital Syphilis →

Sponsor

Tulane University School of Public Health and Tropical Medicine

Who can join

13 and older, female only, with Congenital Syphilis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Audit and feedback: effects on professional practice.
   Ivers N, Yogasingam S, Lacroix M, Brown KA, et al · · 2025 · cited 36× · PMID 40130784 · DOI 10.1002/14651858.cd000259.pub4
2. A multifaceted intervention to improve syphilis screening and treatment in pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia: a cluster randomised controlled trial.
   Althabe F, Chomba E, Tshefu AK, Banda E, et al · · 2019 · cited 27× · PMID 30910531 · DOI 10.1016/s2214-109x(19)30075-0
3. Syphilis screening and treatment in pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia: a cross-sectional study.
   Berrueta M, Cafferata ML, Mwenechanya M, Nkamba Mukadi D, et al · · 2017 · cited 7× · PMID 29355227 · DOI 10.12688/gatesopenres.12768.1
4. Factors associated with HIV and syphilis screenings among pregnant women at first antenatal visit in Lusaka, Zambia.
   Davis R, Xiong X, Althabe F, Lefante J, et al · · 2020 · cited 1× · PMID 32894196 · DOI 10.1186/s13104-020-05266-0