{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T23:54:47Z","timestamp":1792108487646,"version":"4.4.0"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.15173.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2019,11,20]],"date-time":"2019-11-20T00:00:00Z","timestamp":1574208000000}}],"reference-count":72,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2019,11,20]],"date-time":"2019-11-20T00:00:00Z","timestamp":1574208000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002992","name":"Department for International Development, UK Government","doi-asserted-by":"publisher","award":["MR\/N006089\/1"],"award-info":[{"award-number":["MR\/N006089\/1"]}],"id":[{"id":"10.13039\/501100002992","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MR\/N006089\/1"],"award-info":[{"award-number":["MR\/N006089\/1"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004440","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["109351"],"award-info":[{"award-number":["109351"]}],"id":[{"id":"10.13039\/100004440","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001711","name":"Schweizerischer Nationalfonds zur F\u00f6rderung der Wissenschaftlichen Forschung","doi-asserted-by":"publisher","award":["160909\/1"],"award-info":[{"award-number":["160909\/1"]}],"id":[{"id":"10.13039\/501100001711","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["1084429"],"award-info":[{"award-number":["1084429"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004440","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["MR\/N006089\/1"],"award-info":[{"award-number":["MR\/N006089\/1"]}],"id":[{"id":"10.13039\/100004440","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Papua New Guinea Institute of Medical Research"}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns4:p>\n                    <ns4:bold>Background:<\/ns4:bold>\n                    <ns4:italic>Chlamydia trachomatis<\/ns4:italic>\n                    ,\n                    <ns4:italic>Neisseria gonorrhoeae<\/ns4:italic>\n                    ,\n                    <ns4:italic>Trichomonas vaginalis<\/ns4:italic>\n                    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.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Methods<\/ns4:bold>\n                    : 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 \u2018syndromic\u2019 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 &lt;37 completed weeks of gestation as determined by ultrasound) and\/or low birth weight (&lt;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.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Conclusions:<\/ns4:bold>\n                    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.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Registration:<\/ns4:bold>\n                    <ns4:ext-link xmlns:ns3=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" ns3:href=\"http:\/\/www.isrctn.com\/ISRCTN37134032\">ISRCTN37134032<\/ns4:ext-link>\n                    .\n                  <\/ns4:p>","DOI":"10.12688\/wellcomeopenres.15173.2","type":"journal-article","created":{"date-parts":[[2019,11,20]],"date-time":"2019-11-20T06:20:05Z","timestamp":1574230805000},"page":"53","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":16,"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)"],"prefix":"10.12688","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1558-4822","authenticated-orcid":false,"given":"Andrew J.","family":"Vallely","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William S.","family":"Pomat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Homer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Guy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanley","family":"Luchters","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9500-7234","authenticated-orcid":false,"given":"Glen D. 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Vallely<\/b>; <i>Posted: 07 Jan 2020<\/i>; Many thanks for these valuable comments, which we have addressed in the revised version of the manuscript. A brief summary is also provided below for ease of reference. <b>Group B strep (GBS):<\/b> residual urine and genital specimens are being retained at all visits and will enable us to investigate potential confounders (e.g. GBS, <i>M. genitalium<\/i>) following completion of the trial. <b>HIV status:<\/b> the trial does not have sufficient power to investigate incident HIV infections (antenatal HIV prevalence is around 0.6% in PNG); women found to be HIV positive are referred for specialist review and treatment (available only at provincial-level) after which they may continue antenatal follow-up as part of the trial or continue provincial-level services. <b>Neonatal specimens:<\/b> are collected at multiple time points to evaluate the impact of the intervention on both exposure and infection. <b>Vaginal vs urine specimens: <\/b>Xpert STI test performance is comparable using urine or vaginal specimens (e.g. sensitivity 98%, specificity 99% for detection of chlamydia using either specimen type: https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/23467600); BV testing is not being conducted in the control arm <b>.<\/b> <b>References comparing Xpert and lab based NAATs:<\/b>&nbsp;have now been added.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/4-53\/v2#referee-comment-4040","order":1,"name":"referee-comment-4040","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.17065.r37121, Nicole Young, Liverpool School of Tropical Medicine, Liverpool, UK, 13 Jan 2020, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/4-53\/v2#referee-response-37121","order":2,"name":"referee-response-37121","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Andrew J.&nbsp; Vallely<\/b>; <i>Posted: 16 Jan 2020<\/i>; Many thanks for these further comments and feedback. <b>Comment #1:<\/b> I am happy to call this an effectiveness trial, but could you provide a discussion and scaled score of how 'explanatory' or 'pragmatic' the trial is across the 9 domains on the PRECIS-2 scale? <b>Response #1:<\/b> Across the 9 domains of the PRECIS-2 tool, the trial scored 5 for domains 1,2,3,7 (\u2018Eligibility\u2019, \u2018Recruitment\u2019, \u2018Setting\u2019 and \u2018Follow-up\u2019, respectively); scored 4 for domains 4,5,9 (\u2018Organization\u2019, \u2018Flexibility [delivery]\u2019, and \u2018Analysis\u2019); and scored 3 for domain 6 (\u2018Flexibility [adherence]\u2019). This indicates that the trial has a strong pragmatic focus, as described by Loudon K et al. (The PRECIS-2 tool: designing trials that are fit for purpose. BMJ 2015;350:h2147). We believe that it would be outside the scope of the current protocol paper to include this assessment in a further revised version of the manuscript, given that our trial is now underway and this assessment was not undertaken during the design phase (as recommended). We do however very much recognize the value and importance of this tool and will be using this approach during the design of future intervention trials in Papua New Guinea and other high-burden settings. <b>Comment #2:<\/b> My comment on malaria is that there has been some evidence of SP having a protective effect on STIs (the exposure). Hence, it would be important to have data on those who received SP. <b>Response #2:<\/b> We agree. As noted in our earlier comments, we are collecting data on possible confounders, including malaria (e.g. symptomatic and sub-clinical cases; exposure to SP for antenatal presumptive\/preventative treatment) in the trial. We will describe in more detail how these factors will be taken into consideration in the trial Statistical Analysis Plan that we intend to publish separately.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/4-53\/v2#referee-comment-4051","order":3,"name":"referee-comment-4051","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Nicole Yan<\/b>; <i>Posted: 21 Jan 2020<\/i>; Thank you very much. Best of luck on your trial and I look forward to reading the results!","URL":"https:\/\/wellcomeopenresearch.org\/articles\/4-53\/v2#referee-comment-4057","order":4,"name":"referee-comment-4057","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This trial is sponsored by the Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea. The trial is funded by the Joint Global Health Trials scheme (UK Department for International Development, Medical Research Council, Wellcome Trust; MR\/N006089\/1); National Health and Medical Research Council, Australia (Project Grant 1084429); and Swiss National Science Foundation Research for Development award (IZ07Z0_160909\/1). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":5,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}