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) [version 2; peer review: 2 approved]
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...
Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Wellcome
2019-11-01
|
Series: | Wellcome Open Research |
Online Access: | https://wellcomeopenresearch.org/articles/4-53/v2 |
id |
doaj-63ad2d9a7c6a4295ae83e79070d3e405 |
---|---|
record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Andrew J. Vallely William S. Pomat Caroline Homer Rebecca Guy Stanley Luchters Glen D. L. Mola Grace Kariwiga Lisa M. Vallely Virginia Wiseman Chris Morgan Handan Wand Stephen J. Rogerson Sepehr N. Tabrizi David M. Whiley Nicola Low Rosanna Peeling Peter Siba Michaela Riddell Moses Laman John Bolnga Leanne J. Robinson Jacob Morewaya Steven G. Badman Neha Batura Angela Kelly-Hanku Pamela J. Toliman Wilfred Peter Delly Babona Elizabeth Peach Suzanne M. Garland John M. Kaldor |
spellingShingle |
Andrew J. Vallely William S. Pomat Caroline Homer Rebecca Guy Stanley Luchters Glen D. L. Mola Grace Kariwiga Lisa M. Vallely Virginia Wiseman Chris Morgan Handan Wand Stephen J. Rogerson Sepehr N. Tabrizi David M. Whiley Nicola Low Rosanna Peeling Peter Siba Michaela Riddell Moses Laman John Bolnga Leanne J. Robinson Jacob Morewaya Steven G. Badman Neha Batura Angela Kelly-Hanku Pamela J. Toliman Wilfred Peter Delly Babona Elizabeth Peach Suzanne M. Garland John M. Kaldor 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) [version 2; peer review: 2 approved] Wellcome Open Research |
author_facet |
Andrew J. Vallely William S. Pomat Caroline Homer Rebecca Guy Stanley Luchters Glen D. L. Mola Grace Kariwiga Lisa M. Vallely Virginia Wiseman Chris Morgan Handan Wand Stephen J. Rogerson Sepehr N. Tabrizi David M. Whiley Nicola Low Rosanna Peeling Peter Siba Michaela Riddell Moses Laman John Bolnga Leanne J. Robinson Jacob Morewaya Steven G. Badman Neha Batura Angela Kelly-Hanku Pamela J. Toliman Wilfred Peter Delly Babona Elizabeth Peach Suzanne M. Garland John M. Kaldor |
author_sort |
Andrew J. Vallely |
title |
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) [version 2; peer review: 2 approved] |
title_short |
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) [version 2; peer review: 2 approved] |
title_full |
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) [version 2; peer review: 2 approved] |
title_fullStr |
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) [version 2; peer review: 2 approved] |
title_full_unstemmed |
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) [version 2; peer review: 2 approved] |
title_sort |
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) [version 2; peer review: 2 approved] |
publisher |
Wellcome |
series |
Wellcome Open Research |
issn |
2398-502X |
publishDate |
2019-11-01 |
description |
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. |
url |
https://wellcomeopenresearch.org/articles/4-53/v2 |
work_keys_str_mv |
AT andrewjvallely pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT williamspomat pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT carolinehomer pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT rebeccaguy pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT stanleyluchters pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT glendlmola pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT gracekariwiga pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT lisamvallely pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT virginiawiseman pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT chrismorgan pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT handanwand pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT stephenjrogerson pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT sepehrntabrizi pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT davidmwhiley pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT nicolalow pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT rosannapeeling pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT petersiba pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT michaelariddell pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT moseslaman pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT johnbolnga pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT leannejrobinson pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT jacobmorewaya pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT stevengbadman pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT nehabatura pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT angelakellyhanku pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT pamelajtoliman pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT wilfredpeter pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT dellybabona pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT elizabethpeach pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT suzannemgarland pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved AT johnmkaldor pointofcaretestingandtreatmentofsexuallytransmittedinfectionstoimprovebirthoutcomesinhighburdenlowincomesettingsstudyprotocolforaclusterrandomizedcrossovertrialthewantaimtrialpapuanewguineaversion2peerreview2approved |
_version_ |
1724995219636617216 |
spelling |
doaj-63ad2d9a7c6a4295ae83e79070d3e4052020-11-25T01:52:02ZengWellcomeWellcome Open Research2398-502X2019-11-01410.12688/wellcomeopenres.15173.217065Point-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) [version 2; peer review: 2 approved]Andrew J. Vallely0William S. Pomat1Caroline Homer2Rebecca Guy3Stanley Luchters4Glen D. L. Mola5Grace Kariwiga6Lisa M. Vallely7Virginia Wiseman8Chris Morgan9Handan Wand10Stephen J. Rogerson11Sepehr N. Tabrizi12David M. Whiley13Nicola Low14Rosanna Peeling15Peter Siba16Michaela Riddell17Moses Laman18John Bolnga19Leanne J. Robinson20Jacob Morewaya21Steven G. Badman22Neha Batura23Angela Kelly-Hanku24Pamela J. Toliman25Wilfred Peter26Delly Babona27Elizabeth Peach28Suzanne M. Garland29John M. Kaldor30Papua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New GuineaPapua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New GuineaMacfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, AustraliaThe Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, AustraliaMacfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, AustraliaSchool of Medicine and Health Sciences, University of Papua New Guinea, Port Moresby, NCD, Papua New GuineaMilne Bay Provincial Health Authority, Alotau, MBP, Papua New GuineaPapua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New GuineaThe Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, AustraliaMacfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, AustraliaThe Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, AustraliaDoherty Institute, Department of Medicine, University of Melbourne, Melbourne, VIC, 3050, AustraliaDepartment of Microbiology, The Royal Women’s Hospital Melbourne, Parkville, VIC, 3052, AustraliaUQ Centre for Clinical Research, University of Queensland, Herston, QLD, 4029, AustraliaInstitute of Social and Preventive Medicine, University of Bern, Bern, 3012, SwitzerlandLondon School of Hygiene & Tropical Medicine, London, WC1E 7HT, UKPapua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New GuineaPapua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New GuineaPapua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New GuineaDepartment of Obstetrics & Gynaecology, Modilon General Hospital, Madang, MP, Papua New GuineaMacfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, AustraliaMilne Bay Provincial Health Authority, Alotau, MBP, Papua New GuineaThe Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, AustraliaCentre for Global Health Economics, Institute for Global Health, University College London, London, WC1N 1EH, UKPapua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New GuineaPapua New Guinea Institute of Medical Research, Goroka, EHP, 441, Papua New GuineaProvincial Health Office, Madang, MP, Papua New GuineaSt Mary’s Vunapope Rural Hospital, Kokopo, ENBP, 613, Papua New GuineaMacfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, 3004, AustraliaDepartment of Microbiology, The Royal Women’s Hospital Melbourne, Parkville, VIC, 3052, AustraliaThe Kirby Institute for infection and immunity in society, UNSW Sydney, Sydney, NSW, 2052, AustraliaBackground: 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.https://wellcomeopenresearch.org/articles/4-53/v2 |