Preventing Congenital Syphilis: A strategy to prevent congenital syphilis in the Democratic Republic of the Congo and Zambia
2015 - 2017
Period 2015 – 2017
Researchers
Fernando Althabe, Ezequiel García-Elorrio, Mabel Berrueta, María Luisa Caferatta, Agustina Mazzoni, Eduardo Bergel, Alvaro Ciganda, María Belizán, Karen Klein, Cintia Spira.
Objectives
To evaluate a multifaceted intervention to increase the use of evidence-based practices to prevent congenital syphilis in the Democratic Republic of the Congo (DRC) and Zambia.
Summary
The study is being carried out in the Democratic Republic of the Congo and Zambia. The IECS carries out the coordination and management of data (Data Center).
The clusters correspond to geographic areas with several prenatal clinics. After a six-month period of baseline data collection, the groups will be randomly assigned to an intervention group or a control group. For 18 months, prenatal clinics in the intervention groups will conduct the multifaceted behavioral intervention. Antenatal clinics in the control groups will continue with their usual activities. Supplies for screening and treatment will be provided to the intervention and control groups. Data collected during the last six months of the intervention period will be compared with baseline data.
-About the Intervention (“Supplies + Plus”): will be multifaceted, adapted by formative research, and includes: · Identification and training of opinion leaders among prenatal health providers, who allow dissemination, implementation and maintenance of best practices in evidence through reminders, monitoring and feedback; Packaging of supplies in kits: - rapid test or point-of-care kits for the diagnosis of syphilis with instructions for immediate treatment if positive; - treatment kits (penicillin benzathine 2,4 MU, syringe and needle, instructions and information on side effects); -anaphylactic reaction treatment kits for emergency use if necessary (one kit contains items necessary for the treatment of an anaphylactic adverse reaction according to local practice guidelines).
-Access to supplies in control groups: We will ensure that control groups have access to rapid or point-of-care tests for syphilis diagnosis and treatment resources (“Materials”).
- Main results:1. Pregnant women receiving prenatal care with positive confirmation for syphilis who are treated at their first prenatal visit.2. Pregnant women receiving prenatal care who are tested for syphilis during their first prenatal visit. We will also measure the impact of the intervention on other components of prenatal care (screening for anemia, HIV and proteinuria) (secondary events).
Financing: Bill & Melinda Gates Foundation.
- Principal investigator: Pierre Buekens, MD, PhD, WH Watkins Professor and Dean School of Public Health and Tropical Medicine, TulaneUniversity.
- Associated centers:
Argentina Institute of Clinical and Health Effectiveness.
Democratic Republic of Congo University of Kinshasa, Kinshasa School of Public Health.
Zambia University Teaching Hospital, University of Zambia, School of Medicine.
Designer
Group-randomized clinical trial (clusters), with two parallel arms between care centers.
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