Preventing Congenital Syphilis

NCT02353117 | Completed DMC

• 1 other identifier: OPP1116131
• Study Type: interventional
• Target: 60,386
• Locations: 4 countries
• Sites: 4

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.

Conditions

Congenital Syphilis

Outcome Measures

Primary Outcomes (1)

• The frequency of pregnant women attending prenatal care screened for syphilis and treated if infected

  18 months

Secondary Outcomes (1)

• The number of women who receive screening for other components of prenatal care (anemia, HIV, proteinuria).

  18 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

Congenital Syphilis Intervention Group BEHAVIORAL

Intervention

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Tulane University School of Public Health and Tropical Medicine: lead
• Instituto de Efectividad Clinica y Sanitaria (IECS): collaborator
• Kinshasa School of Public Health: collaborator
• University of Zambia: collaborator

Study Sites (4)

Tulane School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

Location

Institute for Clinical Effectiveness and Health Policy

Buenos Aires, Argentina

Location

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Location

University Teaching Hospital, University of Zambia

Lusaka, Zambia

Location

Related Publications (1)

• Althabe F, Chomba E, Tshefu AK, Banda E, Belizan M, Bergel E, Berrueta M, Bertrand J, Bose C, Cafferata ML, Carlo WA, Ciganda A, Donnay F, Garcia Elorrio E, Gibbons L, Klein K, Liljestrand J, Lusamba PD, Mavila AK, Mazzoni A, Nkamba DM, Mwanakalanga FH, Mwapule Tembo A, Mwenechanya M, Pyne-Mercier L, Spira C, Wetshikoy JD, Xiong X, Buekens P. 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. Lancet Glob Health. 2019 May;7(5):e655-e663. doi: 10.1016/S2214-109X(19)30075-0. Epub 2019 Mar 22.

  PMID: 30910531 DERIVED

MeSH Terms

Conditions

Syphilis, Congenital

Condition Hierarchy (Ancestors)

Syphilis; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pierre Buekens, MD, PhD

  Tulane SPHTM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: W.H. Watkins Professor and Dean

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 2, 2015
• Study Start: January 11, 2016
• Primary Completion: July 14, 2017
• Study Completion: February 28, 2018
• Last Updated: April 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1); ZA (1); US (1); DE (1)