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However, the efficacy of IPTp-SP has decreased in step with increasing parasite drug resistance. Suitable alternative strategies are needed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This is a protocol for a phase IIIb open-label, two-armed randomized controlled superiority trial to assess the safety and efficacy of a hybrid approach to IPTp combining screening and treatment with dihydroartemisinin-piperaquine (DP) to the current IPTp-SP regimen at the first antenatal care clinic visit. Pregnant women without HIV infection and without signs or symptoms of malaria will be randomized to either standard IPTp-SP or hybrid IPTp-SP plus screening and treatment (IPTp-SP+). In the IPTp-SP+ arm, participants who screen positive by rapid diagnostic test for\n                      <jats:italic>P. falciparum<\/jats:italic>\n                      will be treated with DP at the first antenatal visit while those who screen negative will receive SP per current guidelines. All participants will be administered SP on days 35 and 63 and will be actively followed biweekly up to day 63 and then monthly until delivery. Infants will be followed until 1 year after delivery. The primary endpoint is incident PCR-confirmed MIP at day 42. Secondary endpoints include incident MIP at other time points, placental malaria, congenital malaria, hemoglobin trends, birth outcomes, and incidence of adverse events in infants up to the first birthday.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>A hybrid approach to IPTp that combines screening and treatment with an artemisinin-based combination therapy at the first visit with standard IPTp-SP is hypothesized to confer added benefit over IPTp-SP alone in a high malaria transmission area with prevalent SP resistant parasites.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Pan African Clinical Trials Registry\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/pactr.samrc.ac.za\/TrialDisplay.aspx?TrialID=8129\">201905721140808<\/jats:ext-link>\n                      . Registered retrospectively on 11 May 2019\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05745-0","type":"journal-article","created":{"date-parts":[[2021,11,20]],"date-time":"2021-11-20T05:02:49Z","timestamp":1637384569000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and efficacy of intermittent presumptive treatment with sulfadoxine-pyrimethamine using rapid diagnostic test screening and treatment with dihydroartemisinin-piperaquine at the first antenatal care visit (IPTp-SP+): study protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0339-9101","authenticated-orcid":false,"given":"Jean-Bertin Bukasa","family":"Kabuya","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew M.","family":"Ippolito","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jay","family":"Sikalima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clifford","family":"Tende","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Davies","family":"Champo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Mwakazanga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna Marie P.","family":"Young","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Modest","family":"Mulenga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gershom","family":"Chongwe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Manyando","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,11,20]]},"reference":[{"key":"5745_CR1","volume-title":"World Malaria Report","author":"World Health Organization","year":"2020","unstructured":"World Health Organization. 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For future publications, authorship will be determined on the basis of the International Committee of Medical Journal Editors. All individuals who have made substantial contributions to the conception or design of the protocol; acquisition, analysis, or interpretation of data will be part of the publication committee. The PI will lead the committee and will be the lead author for publications under this protocol. PIs of ancillary studies will be considered as lead authors. Disputes regarding authorship will be settled by TDRC directorate. Professional writers be used if need arises.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication and future authorship eligibility {31b}"}},{"value":"This protocol has been approved by the European and Developing Countries Clinical Trial Partnership Ethics Review Committee, the Tropical Diseases Research Centre Ethics Review Committee, the Zambia Medicine Regulatory Authority, and the National Health Research Ethics Board of the Ministry of Health of the Government of the Republic of Zambia. All study participants will undergo written informed consent. A copy of the informed consent is included in the additional files.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"JBK is an EDCTP fellow. The other authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"820"}}