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Preventing Congenital Syphilis (PCS)

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ClinicalTrials.gov Identifier: NCT02353117
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
Instituto de Efectividad Clinica y Sanitaria (IECS)
Kinshasa School of Public Health
University of Zambia
Information provided by (Responsible Party):
Dr. Pierre Buekens, Tulane University

Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Syphilis Behavioral: Congenital Syphilis Intervention Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Congenital Syphilis
Actual Study Start Date : January 11, 2016
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Syphilis

Arm Intervention/treatment
Active Comparator: Intervention
Behavioral intervention. The intervention will be multifaceted, tailored by formative research, and include: 1) opinion leaders, reminders, monitoring, and feedback; 2) point-of-care rapid tests and immediate treatment if the rapid test is positive; and 3) locally packaged treatment kits (benzathine penicillin 2.4 MIU, syringe and needle, instructions, and information on side-effects).
Behavioral: Congenital Syphilis Intervention Group
No Intervention: Control
Prenatal care providers at control clinics will be invited to participate in a training workshop. They will be given refresher concepts on the prenatal care package and maternal and congenital syphilis and will be trained in syphilis case detection and management, using their standard and available screening methods. They will also be trained on how to document the screening and treatment process, using the same system as the intervention clinics. No other activities are planned in the control group; providers will be encouraged to disseminate and implement any strategy they consider useful to improve screening and treatment. Study personnel will ensure the availability of screening tests already in-use, as well as ensure the availability of benzathine penicillin at all control prenatal clinics.



Primary Outcome Measures :
  1. The frequency of pregnant women attending prenatal care screened for syphilis and treated if infected [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. The number of women who receive screening for other components of prenatal care (anemia, HIV, proteinuria). [ Time Frame: 18 months ]


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Pregnant women who present for prenatal care at a participating prenatal care clinic for the first time who consent to participate in the study.

Exclusion Criteria: Pregnant women who do not agree to participate in the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353117


Locations
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United States, Louisiana
Tulane School of Public Health and Tropical Medicine
New Orleans, Louisiana, United States, 70112
Argentina
Institute for Clinical Effectiveness and Health Policy
Buenos Aires, Argentina
Congo, The Democratic Republic of the
Kinshasa School of Public Health
Kinshasa, Congo, The Democratic Republic of the
Zambia
University Teaching Hospital, University of Zambia
Lusaka, Zambia
Sponsors and Collaborators
Tulane University School of Public Health and Tropical Medicine
Instituto de Efectividad Clinica y Sanitaria (IECS)
Kinshasa School of Public Health
University of Zambia
Investigators
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Principal Investigator: Pierre Buekens, MD, PhD Tulane SPHTM
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Pierre Buekens, W.H. Watkins Professor and Dean, Tulane University
ClinicalTrials.gov Identifier: NCT02353117    
Other Study ID Numbers: OPP1116131
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Syphilis
Syphilis, Congenital
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Infant, Newborn, Diseases