Point-of-care testing and treatment of sexually transmitted infections to improve birth outcomes in high-burden, low-income settings: Study protocol for a cluster randomized crossover trial (the WANTAIM Trial, Papua New Guinea)

Wellcome Open Research

article

Andrew J. Vallely¹  William S. Pomat¹  Caroline Homer³  Rebecca Guy²  Stanley Luchters³  Glen D. L. Mola⁴  Grace Kariwiga⁵  Lisa M. Vallely¹  Virginia Wiseman²  Elizabeth Peach³  Chris Morgan³  Handan Wand²  Stephen J. Rogerson⁷  Sepehr N. Tabrizi⁸  David M. Whiley^1,10  Nicola Low^1,11  Rosanna Peeling⁶  Peter Siba¹  Michaela Riddell¹  Moses Laman¹  John Bolnga^1,12  Leanne J. Robinson¹  Jacob Morewaya⁵  Steven G. Badman²  Neha Batura^1,13  Angela Kelly-Hanku¹  Pamela J. Toliman¹  Wilfred Peter^1,14  Delly Babona^1,15  Suzanne M. Garland⁸  John M. Kaldor² 

[1] Papua New Guinea Institute of Medical Research;The Kirby Institute for infection and immunity in society;Macfarlane Burnet Institute for Medical Research and Public Health;School of Medicine and Health Sciences, University of Papua New Guinea;Milne Bay Provincial Health Authority;London School of Hygiene & Tropical Medicine;Doherty Institute, Department of Medicine, University of Melbourne;Department of Microbiology, The Royal Women’s Hospital Melbourne;Department of Obstetrics and Gynaecology, University of Melbourne;UQ Centre for Clinical Research, University of Queensland;Institute of Social and Preventive Medicine, University of Bern;Department of Obstetrics & Gynaecology, Modilon General Hospital;Centre for Global Health Economics, Institute for Global Health, University College London;Provincial Health Office;St Mary’s Vunapope Rural Hospital

关键词: sexually transmitted infection;    pregnancy;    preterm birth;    low birth weight;    cluster randomised crossover trial;    Papua New Guinea;   

DOI  :  10.12688/wellcomeopenres.15173.2

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Background: Chlamydia trachomatis,Neisseria gonorrhoeae,Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight.Methods: The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI ‘syndromic’ management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery <37 completed weeks of gestation as determined by ultrasound) and/or low birth weight (<2500 g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care.Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide.Registration: ISRCTN37134032.

【 授权许可】

CC BY