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Wellcome Open Res. 2019 Mar 22;4:53. doi: 10.12688/wellcomeopenres.15173.2. eCollection 2019.

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).

Author information

1
Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New Guinea.
2
The Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, Australia.
3
Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, Australia.
4
School of Medicine and Health Sciences, University of Papua New Guinea, Port Moresby, NCD, Papua New Guinea.
5
Milne Bay Provincial Health Authority, Alotau, MBP, Papua New Guinea.
6
London School of Hygiene & Tropical Medicine, London, WC1E 7HT, UK.
7
Doherty Institute, Department of Medicine, University of Melbourne, Melbourne, VIC, 3050, Australia.
8
Department of Microbiology, The Royal Women's Hospital Melbourne, Parkville, VIC, 3052, Australia.
9
Department of Obstetrics and Gynaecology, University of Melbourne, Carlton, VIC, 3053, Australia.
10
UQ Centre for Clinical Research, University of Queensland, Herston, QLD, 4029, Australia.
11
Institute of Social and Preventive Medicine, University of Bern, Bern, 3012, Switzerland.
12
Department of Obstetrics & Gynaecology, Modilon General Hospital, Madang, MP, Papua New Guinea.
13
Centre for Global Health Economics, Institute for Global Health, University College London, London, WC1N 1EH, UK.
14
Provincial Health Office, Madang, MP, Papua New Guinea.
15
St Mary's Vunapope Rural Hospital, Kokopo, ENBP, 613, Papua New Guinea.

Abstract

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.

KEYWORDS:

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

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