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This is of particular concern for children and adolescents, who experience high rates of treatment failure. The GIVE MOVE trial assesses the clinical impact and cost-effectiveness of routinely providing genotypic resistance testing (GRT) to children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>GIVE MOVE is an open-label randomised clinical trial enrolling children and adolescents (\u22656\u2009months to &lt;19\u2009years) living with HIV with a VL \u2265400 copies\/mL (c\/mL) while taking first-line ART. Recruitment takes place at sites in Lesotho and Tanzania. Participants are randomised in a 1:1 allocation to a control arm receiving the standard of care (3 sessions of enhanced adherence counselling, a follow-up VL test, continuation of the same regimen upon viral resuppression or empiric selection of a new regimen upon sustained elevated viremia) and an intervention arm (GRT to inform onward treatment). The composite primary endpoint is the occurrence of any one or more of the following events during the 36\u2009weeks of follow-up period: i) death due to any cause; ii) HIV- or ART-related hospital admission of \u226524\u2009h duration; iii) new clinical World Health Organisation stage 4 event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis); and iv) no documented VL &lt;50 c\/mL at 36\u2009weeks follow-up. Secondary and exploratory endpoints assess additional health-related outcomes, and a nested study will assess the cost-effectiveness of the intervention. Enrolment of a total of 276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Discussion<\/jats:title>\n<jats:p>This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>This trial is registered with <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04233242\">NCT04233242<\/jats:ext-link>; registered 18.01.2020). More information: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.givemove.org\">www.givemove.org<\/jats:ext-link>.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s12879-020-05491-9","type":"journal-article","created":{"date-parts":[[2020,10,19]],"date-time":"2020-10-19T13:04:25Z","timestamp":1603112665000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania"],"prefix":"10.1186","volume":"20","author":[{"given":"Jennifer Anne","family":"Brown","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isaac","family":"Ringera","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ezekiel","family":"Luoga","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Molisana","family":"Cheleboi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Namvua","family":"Kimera","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Josephine","family":"Muhairwe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Buntshi Paulin","family":"Kayembe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mosa","family":"Molapo Hlasoa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lorraine","family":"Kabundi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ching Wey David","family":"Yav","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Buoang","family":"Mothobi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lineo","family":"Thahane","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alain","family":"Amstutz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nadine","family":"Bachmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Getrud Joseph","family":"Mollel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moniek","family":"Bresser","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tracy Ren\u00e9e","family":"Glass","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel Henry","family":"Paris","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Klimkait","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maja","family":"Weisser","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3599-1791","authenticated-orcid":false,"given":"Niklaus Daniel","family":"Labhardt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,10,19]]},"reference":[{"key":"5491_CR1","volume-title":"Key HIV epidemiology indicators for children and adolescents aged 0\u201319, 2000\u20132018","author":"UNICEF","year":"2019","unstructured":"UNICEF. 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In addition, the Ethikkommission Nordwest- und Zentralschweiz in Switzerland provided a statement confirming the trial meets all requirements for a Swiss research project (Req-2019-01275).Written informed consent and, where applicable, written informed assent is a prerequisite for participation in this study. The consenting process is conducted by an authorised member of the study team based at the respective site. Before deciding whether or not to consent, participants\/caregivers are given detailed information about the study, and are informed that they will continue to receive the standard of care if they choose not to participate and that they may withdraw their consent at any time. Participants aged \u226516\u2009years (Lesotho) or\u2009\u226518\u2009years (Tanzania) fill in an Informed Consent Form. For children and younger adolescents below these age thresholds, a caregiver fills in a separate Informed Consent Form for caregivers. Within the approved study protocol, a caregiver is defined as a parent, a legal guardian, or an adult aged \u226518\u2009years and living in the same household as the participant. In addition, participants aged \u226512 and\u2009<16\u2009years (Lesotho) or\u2009\u226512 and\u2009<\u200918\u2009years (Tanzania) fill in an Informed Assent Form for Adolescents, and those aged \u22656 and\u2009<12\u2009years fill in a simplified Informed Assent Form for Children. All forms are available in English as well as Sesotho (Lesotho) or Swahili (Tanzania). In the case of illiteracy, consent\/assent is given by thumb print, and a witness signature is required.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"TK reports advisory board membership fees from ViiV and Gilead for work outside of this study. All other authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"773"}}