Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02353117 |
| Other study ID # |
OPP1116131 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 21, 2015 |
| Last updated |
April 25, 2018 |
| Start date |
January 11, 2016 |
| Est. completion date |
February 28, 2018 |
Study information
| Verified date |
April 2018 |
| Source |
Tulane University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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:
1. Opinion leaders, reminders, monitoring, and feedback;
2. Point-of-care rapid tests and immediate treatment if the rapid test is positive;
3. 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.
