Background

Why is WANTAIM being carried out?

Previous studies have shown that curable, sexually transmitted and genital infections (STIs), such as chlamydia, gonorrhoea, trichomonas and bacterial vaginosis can increase the risk of low birth weight, preterm birth and other adverse birth outcomes if these infections are not diagnosed and treated in pregnancy.

Evidence for the potential impact of antenatal STI screening and treatment is conflicting however. This has led to different screening guidelines being adopted in different countries worldwide. Newly-available technologies make it possible for the first time to conduct definitive field trials to answer questions that have remained unresolved for decades.

WANTAIM will investigate if point-of-care testing and immediate treatment of chlamydia, gonorrhoea, trichomonas and bacterial vaginosis among pregnant women leads to improved birth outcomes in the high-burden, low-income setting of Papua New Guinea. WANTAIM will also evaluate the cost-effectiveness, acceptability and health system implementation requirements of antenatal point-of-care STI testing and treatment.

How will the study be conducted?

WANTAIM is being carried out at 10 antenatal clinics in three provinces in Papua New Guinea. A total of around 4600 pregnant women will take part.
Pregnant women aged 16 years and above, attending their first antenatal clinic visit at 26 weeks of pregnancy or less, will be eligible to join the study.
WANTAIM will compare birth outcomes among women provided with:
a) routine antenatal care alone
b) routine antenatal care plus point-of-care STI testing and immediate treatment
Women in both groups will receive antenatal care in accordance with PNG national guidelines. This includes routine screening for HIV infection and syphilis, which will be provided by experienced health facility staff. In all participating clinics, the WANTAIM study team will work closely with health facility staff to ensure the highest possible standard of care is provided to women.
WANTAIM is a cluster randomised crossover trial. This means that each of the 10 antenatal clinics and their catchment communities will have an opportunity to take part in both of the above treatment and care groups. In the first phase of the study, five clinics will provide routine antenatal care alone, and five clinics will provide routine antenatal care plus point-of-care STI testing and treatment. Once recruitment and follow-up in the first phase are completed, there will be a short rest period, after which clinics will crossover to provide the alternative treatment and care option.

Further details about the design and conduct of the study can be found here

Why is this study important?

Women in many low-income countries worldwide face a high and unacceptable burden of adverse pregnancy outcomes. Curable, sexually transmitted and genital infections, such as chlamydia, gonorrhoea, trichomonas and bacterial vaginosis, are considered major contributors to this disease burden but the majority of infections go untreated because:
(a) most infections are asymptomatic, and
(b) affordable, easy to use and accurate diagnostic tests are unavailable in such settings.
Newly-available technologies make it possible to evaluate antenatal point-of-care testing and treatment of these infections for the first time.
If antenatal point-of-care STI testing and treatment is proven to reduce adverse birth outcomes in Papua New Guinea, the study will hasten access to these technologies and thereby lead to improved maternal and neonatal health in low-income settings worldwide.