Protecting Mothers and their Infants through Screening and Comprehensive Management of Sexually Transmitted Infections in Antenatal Care in Zimbabwe
Lead Research Organisation:
London School of Hygiene & Tropical Medicine
Department Name: Clinical Research
Abstract
Sexually transmitted infections (STIs) are extremely common. In Africa four easily curable STIs (chlamydia, gonorrhoea, trichomoniasis and syphilis) may affect almost one in four young people at any point in time. For most people these infections do not cause obvious symptoms but they can still be associated with important health consequences. In particular, STIs during pregnancy can have severe consequences for the outcome of the pregnancy. They are associated with a higher rate of stillbirth, babies dying shortly after birth (neonatal death), and with babies being born prematurely and at a lower birthweight.
Despite these important public health consequences, control of STIs has not been suboptimal and no World Health Organization (WHO) STI control targets have been met. One reason is that currently only individuals with STI symptoms are treated for all the possible infections that can cause the symptom without specifically testing for which infection is causing the symptom-an approach called syndromic management. This approach was recommended because testing required expensive laboratory infrastructure which was not always possible in resource-constrained settings. Importantly, more than 80% of people with an STI do not have symptoms and are therefore not identified and treated.
Newer diagnostic tests which do not require expensive infrastructure have become available in recent years but these tests are relatively expensive, and there is limited evidence on which population groups to target for testing and whether screening (i.e. offering testing systematically to defined groups whether or not they have symptoms) will result in health benefits.
In previous work in Zimbabwe, we have shown that these diagnostic tests can be integrated into broader antenatal care. However critical data on whether using these tests improves outcomes for mothers and babies is missing. In this study we will conduct a trial to to assess if introducing screening for STIs in antenatal care compared to syndromic management results in improved outcomes for the mothers and their babies.
Our study will be conducted in antenatal care clinics in Zimbabwe. We will enrol approximately 8200 pregnant women into the study. Pregnant women will be assigned by chance (randomised) to either receive standard care, where they will be treated for an STI only if they have symptoms, or to receive a test for an STI whether or not they hae symptoms, followed by treatment based on the result of that test. For each pregnancy we will collect data on important outcomes including stillbirth, prematurity and birth weight to assess if STI testing improves pregnancy outcomes. We will also collect data on the cost of using diagnostic tests in the antenatal setting and conduct a thorough evaluation of the operational and structural factors required for Ministries of Health to adopt STI testing as part of antenatal care more widely.
Throughout the study we will work directly with communities to ensure the services we develop are appropriate for their needs and tackle barriers to seeking care for STIs such as stigma. We will develop a detailed plan to facilitate uptake of our study findings into local, regional and global policy, working with the Ministry of Health, WHO and other key stakeholders such as the International Union against STIs. We will also advocate with Industry for reductions in costs of tests. If successful our study will transform care for pregnant women and improve outcomes for their babies worldwide.
Despite these important public health consequences, control of STIs has not been suboptimal and no World Health Organization (WHO) STI control targets have been met. One reason is that currently only individuals with STI symptoms are treated for all the possible infections that can cause the symptom without specifically testing for which infection is causing the symptom-an approach called syndromic management. This approach was recommended because testing required expensive laboratory infrastructure which was not always possible in resource-constrained settings. Importantly, more than 80% of people with an STI do not have symptoms and are therefore not identified and treated.
Newer diagnostic tests which do not require expensive infrastructure have become available in recent years but these tests are relatively expensive, and there is limited evidence on which population groups to target for testing and whether screening (i.e. offering testing systematically to defined groups whether or not they have symptoms) will result in health benefits.
In previous work in Zimbabwe, we have shown that these diagnostic tests can be integrated into broader antenatal care. However critical data on whether using these tests improves outcomes for mothers and babies is missing. In this study we will conduct a trial to to assess if introducing screening for STIs in antenatal care compared to syndromic management results in improved outcomes for the mothers and their babies.
Our study will be conducted in antenatal care clinics in Zimbabwe. We will enrol approximately 8200 pregnant women into the study. Pregnant women will be assigned by chance (randomised) to either receive standard care, where they will be treated for an STI only if they have symptoms, or to receive a test for an STI whether or not they hae symptoms, followed by treatment based on the result of that test. For each pregnancy we will collect data on important outcomes including stillbirth, prematurity and birth weight to assess if STI testing improves pregnancy outcomes. We will also collect data on the cost of using diagnostic tests in the antenatal setting and conduct a thorough evaluation of the operational and structural factors required for Ministries of Health to adopt STI testing as part of antenatal care more widely.
Throughout the study we will work directly with communities to ensure the services we develop are appropriate for their needs and tackle barriers to seeking care for STIs such as stigma. We will develop a detailed plan to facilitate uptake of our study findings into local, regional and global policy, working with the Ministry of Health, WHO and other key stakeholders such as the International Union against STIs. We will also advocate with Industry for reductions in costs of tests. If successful our study will transform care for pregnant women and improve outcomes for their babies worldwide.