- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02353117
Preventing Congenital Syphilis (PCS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Scope:
The investigators will use implementation research methods to evaluate a multifaceted intervention to increase the use of evidence-based clinical procedures to prevent congenital syphilis. Improving syphilis screening and treatment will be promoted as a key step toward improving the quality of all components of prenatal care.
The objective is to increase the frequency of pregnant women attending prenatal care screened for syphilis and treated if infected (primary outcomes). The investigators will also measure the impact of the intervention on other components of prenatal care (screening for anemia, HIV, proteinuria) (secondary outcomes).
Approach:
Design: Facility-based, two-arm parallel cluster randomized implementation trial. Clusters correspond to geographic areas with several prenatal clinics. After a six-month period of baseline data collection, clusters will be randomized to either an intervention group or a control group. For 18 months, the prenatal clinics in the intervention clusters will conduct the multifaceted intervention. The prenatal clinics in the control clusters will continue their usual activities. Data collected during the intervention period will be compared to baseline data.
Sample Size: The investigators are assuming that 300 women will initiate prenatal care per cluster each year. A sample size of 20 clusters (10 per arm) with three women seropositive for syphilis per cluster will achieve more than 80% power to detect an increase in treated women from 50% to 85%, with a significance level of the test of 0.05, and an intracluster correlation coefficient of 0.01. This will give more than 90% power to detect an increase in the number of women with a complete screening from 50% to 75%. Calculations are based on the conservative assumption that 50% of women are screened and 50% are treated at baseline; lower screening and treatment rates at baseline would increase the power of the proposed study.
Settings: DRC (10 clusters), Zambia (10 clusters), and Argentina (Data Center).
- In the DRC, the study will be performed in the Maluku and Nsele health areas, which are located within the capital city-province of Kinshasa.
- In Zambia, the study will be performed in the health areas of Kafue and Chongwe, which are located within the capital province of Lusaka.
- The Data Center will be located in Buenos Aires, Argentina.
Intervention: The intervention will be multifaceted, tailored by formative research, and include:
- Opinion leaders, reminders, monitoring, and feedback;
- Point-of-care rapid tests and immediate treatment if the rapid test is positive;
- Locally packaged treatment kits (benzathine penicillin 2.4 MIU, syringe and needle, instructions, and information on side-effects).
Even though screening and treatment should occur as early as possible during pregnancy, benefit is expected at any stage of pregnancy. No woman will be excluded based on gestational age.
Opinion leaders in the intervention prenatal clinics will be identified by their peers and invited to work as "facilitators." Training will include: the content of the prenatal care package recommended by WHO and the need to improve the quality of all components of prenatal care; the importance of maternal and congenital syphilis and case management based on WHO recommendations; screening with point-of-care rapid tests and same-day treatment for those found positive; managing allergies to penicillin; how to ensure that all pregnant women are screened; and how to conduct one-on-one detailing visits with prenatal clinic providers to discuss their views regarding the implementation of the screening and treatment program.
After completing the training, the facilitators will return to their prenatal clinics to implement the program, which will include training other prenatal care providers and conducting personal visits with each of them to discuss their perspectives and potential barriers. The facilitators will be responsible for placing the treatment kits in convenient sites to ensure ease of use in infected women and for developing simple reminders to be placed in consultation offices and patient waiting areas. The facilitator teams will also produce periodical reports on the rates of syphilis screening and treatment and will distribute these reports to all prenatal care providers. Cluster coordinators will meet periodically with each team to assess the completion of activities and to address unexpected problems. The intervention will be refined, taking into account the information obtained during the formative research phase. Thus, the components described above may be modified after the formative research stage.
Activities at Control Clinics: As a standard training procedure, prenatal care providers at control clinics will be invited to participate in a half-day 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. Additionally, they will 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, but prenatal care providers will be encouraged to disseminate and implement any strategy they consider useful to improve the screening and treatment process. 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Buenos Aires, Argentina
- Institute for Clinical Effectiveness and Health Policy
-
-
-
-
-
Kinshasa, Congo, The Democratic Republic of the
- Kinshasa School of Public Health
-
-
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane School of Public Health and Tropical Medicine
-
-
-
-
-
Lusaka, Zambia
- University Teaching Hospital, University of Zambia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The frequency of pregnant women attending prenatal care screened for syphilis and treated if infected
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of women who receive screening for other components of prenatal care (anemia, HIV, proteinuria).
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pierre Buekens, MD, PhD, Tulane SPHTM
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPP1116131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Syphilis
-
Stanford UniversitySanta Clara Valley Medical CenterWithdrawnCongenital Syphilis | Maternal Syphilis During Pregnancy - Baby Not Yet DeliveredUnited States
-
University Hospital, GenevaFonds national SuisseCompleted
-
Hospital de Niños R. Gutierrez de Buenos AiresRecruitingChagas Disease | SyphilisArgentina
-
Ottawa Hospital Research InstituteCIHR Canadian HIV Trials NetworkTerminatedSyphilis | Primary Syphilis | Secondary Syphilis | Early-Latent SyphilisCanada
-
Fundación FLS de Lucha Contra el Sida, las Enfermedades...RecruitingPrimary Syphilis | Secondary Syphilis | Early Latent SyphilisSpain, United Kingdom
-
University of Alabama at BirminghamRecruiting
-
Hospital de Niños R. Gutierrez de Buenos AiresCompleted
-
Hospital de Niños R. Gutierrez de Buenos AiresCompleted
-
MedMira Laboratories Inc.Public Health Agency of Canada (PHAC)RecruitingSyphilis | Syphilis Infection | Early Syphilis, SymptomaticCanada
-
National Taiwan University HospitalChang Gung Memorial Hospital; Kaohsiung Medical University Chung-Ho Memorial... and other collaboratorsCompletedEarly Syphilis | Serologic Response of Syphilis | High Risk BehaviorTaiwan
Clinical Trials on Congenital Syphilis Intervention Group
-
Muğla Sıtkı Koçman UniversityNot yet recruiting
-
University of LiegeCentre Hospitalier Universitaire de Liege; Bial Foundation; FNRS (Télévie); Fondation...RecruitingPain | Cancer | Fatigue | Cognitive Impairment | Sleep Disturbance | Distress, EmotionalBelgium
-
Hospital de Clinicas de Porto AlegreUnknown
-
University of California, San FranciscoNational Cancer Institute (NCI); Cancer Prevention Institute of CaliforniaCompletedHereditary Breast and Ovarian Cancer Syndrome
-
University of Sao PauloCompletedAnxiety | Self Esteem
-
Haute Ecole de Santé VaudCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipSwitzerland
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases
-
Azienda Ospedaliero-Universitaria CareggiRecruiting
-
University of OxfordOxford Brookes UniversityRecruitingOverweight/Obesity, AdolescentUnited Kingdom
-
Beijing Tsinghua Chang Gung HospitalRecruitingLifestyle Intervention | Non Communicable DiseasesChina