Preventing Congenital Syphilis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60,386
- Locations
- 5
- Primary Endpoint
- The frequency of pregnant women attending prenatal care screened for syphilis and treated if infected
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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).
Intervention: Congenital Syphilis Intervention Group (Behavioral)
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.
Outcomes
Primary Outcomes
The frequency of pregnant women attending prenatal care screened for syphilis and treated if infected
Time Frame: 18 months
Secondary Outcomes
- The number of women who receive screening for other components of prenatal care (anemia, HIV, proteinuria).(18 months)
Investigators
Dr. Pierre Buekens
W.H. Watkins Professor and Dean
Tulane University