{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T15:39:36Z","timestamp":1787672376718,"version":"build-2736575974"},"reference-count":32,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,1,26]],"date-time":"2022-01-26T00:00:00Z","timestamp":1643155200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,1,26]],"date-time":"2022-01-26T00:00:00Z","timestamp":1643155200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100001713","name":"european and developing countries clinical trials partnership","doi-asserted-by":"publisher","award":["RIA2018CO-2512"],"award-info":[{"award-number":["RIA2018CO-2512"]}],"id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Of the 2 million children living with HIV globally, 90% live in sub-Saharan Africa. Despite antiretroviral therapy, longstanding HIV infection is associated with several chronic complications in children including growth failure, particularly stunting and delayed puberty. Vitamin D deficiency, which is highly prevalent among children living with HIV in sub-Saharan Africa, has a further adverse impact on bone health. This trial aims to establish whether supplementation with vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      and calcium carbonate improves musculoskeletal health among peripubertal children living with HIV.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods\/design<\/jats:title>\n                    <jats:p>\n                      We will conduct an individually randomised, double-blinded, placebo-controlled trial of weekly high-dose vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      (20,000 IU) plus daily calcium carbonate (500mg) supplementation for 48 weeks. Eight hundred and forty\u00a0children living with HIV aged 11\u201319 years taking ART for \u22656 months will be enrolled and followed up for 96 weeks. The primary outcome is total body less-head bone mineral content for lean mass adjusted for height (TBLH-BMC\n                      <jats:sup>LBM<\/jats:sup>\n                      )\n                      <jats:italic>Z<\/jats:italic>\n                      -score at 48 weeks, measured by dual-energy X-ray absorptiometry (DEXA). Secondary outcomes are DEXA-measured lumbar spine bone mineral apparent density\n                      <jats:italic>Z<\/jats:italic>\n                      -score, number of respiratory infections, lean muscle mass and grip strength at 48 and 96 weeks and TBLH-BMC\n                      <jats:sup>LBM<\/jats:sup>\n                      <jats:italic>Z<\/jats:italic>\n                      -scores at 96 weeks. Sub-studies will investigate the effect of the intervention on vitamin D\n                      <jats:sub>3<\/jats:sub>\n                      pathway metabolites and markers of bone turnover, intestinal microbiota, and innate and acquired immune function.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This is the largest trial to date of vitamin D supplementation in children living with HIV. Intervening to address deficits in bone accrual in\u00a0childhood is critical for optimising adolescent and early adult bone health and prevention of later adult osteoporotic fractures. Trial results will draw attention to the need to screen for and treat long-term comorbidities in children living with HIV in resource-limited settings.<\/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\">PACTR20200989766029<\/jats:ext-link>\n                      . Registered on 3 September 2020\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05985-0","type":"journal-article","created":{"date-parts":[[2022,1,26]],"date-time":"2022-01-26T04:02:34Z","timestamp":1643169754000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Vitamin D3 and calcium carbonate supplementation for adolescents with HIV to reduce musculoskeletal morbidity and immunopathology (VITALITY trial): study protocol for a randomised placebo-controlled trial"],"prefix":"10.1186","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3547-8146","authenticated-orcid":false,"given":"Nyasha Veronica","family":"Dzavakwa","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Molly","family":"Chisenga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grace","family":"McHugh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Filteau","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Celia Louise","family":"Gregson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lackson","family":"Kasonka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharina","family":"Kranzer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hildah Banda","family":"Mabuda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilda","family":"Mujuru","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicol","family":"Redzo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Rowland-Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrich E.","family":"Schaible","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Simms","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rashida Abbas","family":"Ferrand","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the VITALITY team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,1,26]]},"reference":[{"key":"5985_CR1","doi-asserted-by":"crossref","unstructured":"Hazra R, Siberry GK, Mofenson LM. Growing up with HIV: children, adolescents, and young adults with perinatally acquired HIV infection. Annu Rev Med [Internet]. 2010 Feb 18 [cited 2021 Apr 24];61:169\u201385 Available from: http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/19622036.","DOI":"10.1146\/annurev.med.050108.151127"},{"issue":"7","key":"5985_CR2","doi-asserted-by":"publisher","first-page":"627","DOI":"10.1016\/S1473-3099(13)70363-3","volume":"14","author":"ED Lowenthal","year":"2014","unstructured":"Lowenthal ED, Bakeera-Kitaka S, Marukutira T, Chapman J, Goldrath K, Ferrand RA. Perinatally acquired HIV infection in adolescents from sub-Saharan Africa: a review of emerging challenges. Lancet Infect Dis. 2014;14(7):627\u201339.","journal-title":"Lancet Infect Dis"},{"key":"5985_CR3","doi-asserted-by":"crossref","unstructured":"Crabtree NJ, Shaw NJ, Bishop NJ, Adams JE, Mughal MZ, Arundel P, et al. Amalgamated Reference Data for Size-Adjusted Bone Densitometry Measurements in 3598 Children and Young Adults-the ALPHABET Study. J Bone Miner Res [Internet]. 2017 Jan 1 [cited 2021 Apr 24];32(1):172\u201380.Available from: https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/27490028.","DOI":"10.1002\/jbmr.2935"},{"issue":"5","key":"5985_CR4","doi-asserted-by":"publisher","first-page":"609","DOI":"10.1097\/QAD.0000000000000590","volume":"29","author":"AJ Szubert","year":"2015","unstructured":"Szubert AJ, Musiime V, Bwakura-Dangarembizi M, Nahirya-Ntege P, Kekitiinwa A, Gibb DM, et al. Pubertal development in HIV-infected African children on first-line antiretroviral therapy. AIDS. 2015;29(5):609\u201318. https:\/\/doi.org\/10.1097\/QAD.0000000000000590.","journal-title":"AIDS"},{"issue":"3","key":"5985_CR5","doi-asserted-by":"publisher","first-page":"e1002514","DOI":"10.1371\/journal.pmed.1002514","volume":"15","author":"AL Slogrove","year":"2018","unstructured":"Slogrove AL, Schomaker M, Davies MA, Williams P, Balkan S, Ben-Farhat J, et al. The epidemiology of adolescents living with perinatally acquired HIV: a cross-region global cohort analysis. PLoS Med. 2018;15(3):e1002514 Available from: https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5832192\/pdf\/pmed.1002514.pdf.","journal-title":"PLoS Med"},{"issue":"12","key":"5985_CR6","doi-asserted-by":"publisher","first-page":"985","DOI":"10.1007\/s001980070020","volume":"11","author":"RP Heaney","year":"2000","unstructured":"Heaney RP, Abrams S, Dawson-Hughes B, Looker A, Marcus R, Matkovic V, et al. Peak bone mass. Osteoporos Int. 2000;11(12):985\u20131009.","journal-title":"Osteoporos Int"},{"issue":"5","key":"5985_CR7","doi-asserted-by":"publisher","first-page":"790","DOI":"10.1359\/jbmr.020602","volume":"21","author":"JM Kindblom","year":"2006","unstructured":"Kindblom JM, Lorentzon M, Norjavaara E, Hellqvist A, Nilsson S, Mellstrom D, et al. Pubertal timing predicts previous fractures and BMD in young adult men: the GOOD study. J Bone Min Res. 2006;21(5):790\u20135 Available from: https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1359\/jbmr.020602.","journal-title":"J Bone Min Res"},{"key":"5985_CR8","unstructured":"Rukuni R, Gregson CL, Ward K, et al. Lower size-adjusted bone density and muscle function in Zimbabwean children with HIV. In: 27th Conference on Retroviruses and Opportunistic Infections; 2020 March 8-11; Boston, USA."},{"issue":"Suppl 1","key":"5985_CR9","doi-asserted-by":"publisher","first-page":"S37","DOI":"10.1097\/00126334-200010001-00006","volume":"25","author":"SM Arpadi","year":"2000","unstructured":"Arpadi SM. Growth failure in children with HIV infection. J Acquir Immune Defic Syndr. 2000;25(Suppl 1):S37\u201342. https:\/\/doi.org\/10.1097\/00126334-200010001-00006.","journal-title":"J Acquir Immune Defic Syndr"},{"issue":"4","key":"5985_CR10","doi-asserted-by":"publisher","first-page":"e966","DOI":"10.1542\/peds.2011-3020","volume":"130","author":"T Gsponer","year":"2012","unstructured":"Gsponer T, Weigel R, Davies MA, Bolton C, Moultrie H, Vaz P, et al. Variability of growth in children starting antiretroviral treatment in southern Africa. Pediatrics. 2012;130(4):e966\u201377.","journal-title":"Pediatrics"},{"issue":"2","key":"5985_CR11","first-page":"97","volume":"3","author":"S Bakeera-Kitaka","year":"2008","unstructured":"Bakeera-Kitaka S, McKellar M, Snider C, Kekitiinwa A, Piloya T, Musoke P, et al. Antiretroviral therapy for HIV-1 infected adolescents in Uganda: assessing the impact on growth and sexual maturation. J Pediatr Infect Dis. 2008;3(2):97\u2013104.","journal-title":"J Pediatr Infect Dis"},{"issue":"4","key":"5985_CR12","doi-asserted-by":"publisher","first-page":"582","DOI":"10.1016\/j.jpeds.2007.12.020","volume":"152","author":"JB Purdy","year":"2008","unstructured":"Purdy JB, Gafni RI, Reynolds JC, Zeichner S, Hazra R. Decreased bone mineral density with off-label use of tenofovir in children and adolescents infected with human immunodeficiency virus. J Pediatr. 2008;152(4):582\u20134.","journal-title":"J Pediatr"},{"key":"5985_CR13","doi-asserted-by":"crossref","unstructured":"Marshall D, Johnell O, Wedel H. Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures. BMJ. 1996;312(7041):1254\u20139. Available from: https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2351094\/pdf\/bmj00542-0020.pdf.\u00a0\u00a0[cited 2021 May 5].","DOI":"10.1136\/bmj.312.7041.1254"},{"key":"5985_CR14","doi-asserted-by":"crossref","unstructured":"Rizzoli R. Nutritional influence on bone: role of gut microbiota. Aging Clin Exp Res.\u00a02019;31(6):743\u201351 Available from: https:\/\/link.springer.com\/article\/10.1007%2Fs40520-019-01131-8. [cited 2021 Apr 24].\u00a0","DOI":"10.1007\/s40520-019-01131-8"},{"key":"5985_CR15","doi-asserted-by":"crossref","unstructured":"Yan J, Takakura A, Zandi-Nejad K, Charles JF. Mechanisms of gut microbiota-mediated bone remodeling. Gut Microbes. \u00a02018;9(1):84\u201392. Available from: https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5914914\/pdf\/kgmi-09-01-1371893.pdf. [cited 2021 Apr 24].\u00a0","DOI":"10.1080\/19490976.2017.1371893"},{"issue":"3","key":"5985_CR16","doi-asserted-by":"publisher","first-page":"678","DOI":"10.3945\/ajcn.111.024786","volume":"95","author":"SM Arpadi","year":"2012","unstructured":"Arpadi SM, McMahon DJ, Abrams EJ, Bamji M, Purswani M, Engelson ES, et al. Effect of supplementation with cholecalciferol and calcium on 2-y bone mass accrual in HIV-infected children and adolescents: a randomized clinical trial. Am J Clin Nutr. 2012;95(3):678\u201385 Available from: https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3278244\/pdf\/ajcn9530678.pdf.","journal-title":"Am J Clin Nutr"},{"key":"5985_CR17","doi-asserted-by":"publisher","unstructured":"Puthanakit T, Saksawad R, Bunupuradah T, Wittawatmongkol O, Chuanjaroen T, Ubolyam S, et al. Prevalence and risk factors of low bone mineral density among perinatally HIV-infected Thai adolescents receiving antiretroviral therapy. J Acquir Immune Defic Synd. \u00a02012;61(4):477. Available from:\u00a0https:\/\/doi.org\/10.1097\/QAI.0b013e31826ea89b.\u00a0 [cited 2021 Apr 30].","DOI":"10.1097\/QAI.0b013e31826ea89b"},{"issue":"4","key":"5985_CR18","doi-asserted-by":"publisher","first-page":"315","DOI":"10.3851\/IMP3199","volume":"23","author":"AR Eckard","year":"2018","unstructured":"Eckard AR, O\u2019Riordan MA, Rosebush JC, Lee ST, Habib JG, Ruff JH, et al. Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth. Antivir Ther. 2018;23(4):315\u201324.","journal-title":"Antivir Ther"},{"issue":"18","key":"5985_CR19","doi-asserted-by":"publisher","first-page":"2677","DOI":"10.1097\/QAD.0000000000000472","volume":"28","author":"V Fabre-Mersseman","year":"2014","unstructured":"Fabre-Mersseman V, Tubiana R, Papagno L, Bayard C, Briceno O, Fastenackels S, et al. Vitamin D supplementation is associated with reduced immune activation levels in HIV-1-infected patients on suppressive antiretroviral therapy. AIDS. 2014;28(18):2677\u201382 Available from: http:\/\/ovidsp.tx.ovid.com\/ovftpdfs\/FPDDNCGCIELBPK00\/fs046\/ovft\/live\/gv025\/00002030\/00002030-201411280-00005.pdf.","journal-title":"AIDS"},{"key":"5985_CR20","doi-asserted-by":"crossref","unstructured":"Martineau AR, Jolliffe DA, Hooper RL, Greenberg L, Aloia JF, Bergman P, et al. Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data. BMJ. \u00a02017;356:i6583. Available from: http:\/\/www.bmj.com\/content\/bmj\/356\/bmj.i6583.full.pdf. [cited 25 Apr 2021].\u00a0","DOI":"10.1136\/bmj.i6583"},{"issue":"5","key":"5985_CR21","doi-asserted-by":"publisher","first-page":"276","DOI":"10.1016\/S2213-8587(21)00051-6","volume":"9","author":"DA Jolliffe","year":"2021","unstructured":"Jolliffe DA, Camargo CA, Sluyter JD, Aglipay M, Aloia JF, Ganmaa D, et al. Vitamin D supplementation to prevent acute respiratory infections: a systematic review and meta-analysis of aggregate data from randomised controlled trials. Lancet Diabetes Endocrinol. 2021;9(5):276\u201392. https:\/\/doi.org\/10.1016\/S2213-8587(21)00051-6.","journal-title":"Lancet Diabetes Endocrinol"},{"key":"5985_CR22","doi-asserted-by":"crossref","unstructured":"Hernandez CJ, Beaupre GS, Carter DR. A theoretical analysis of the relative influences of peak BMD, age-related bone loss and menopause on the development of osteoporosis. Osteoporos\u00a0Int. \u00a02003;14(10):843\u20137 Available from: https:\/\/link.springer.com\/article\/10.1007%2Fs00198-003-1454-8. [cited 2021 Apr 30].","DOI":"10.1007\/s00198-003-1454-8"},{"key":"5985_CR23","unstructured":"U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. [July 2017]. Available from: https:\/\/rsc.niaid.nih.gov\/sites\/default\/files\/daidsgradingcorrectedv21.\u00a0"},{"key":"5985_CR24","doi-asserted-by":"crossref","unstructured":"Rukuni R, Gregson C, Kahari C, Kowo F, McHugh G, Munyati S, et al. The IMpact of Vertical HIV infection on child and Adolescent SKeletal development in Harare, Zimbabwe (IMVASK Study): a protocol for a prospective cohort study. BMJ Open. \u00a02020;10(2):31792. Available from: http:\/\/bmjopen.bmj.com\/. [cited 2021 Apr 30].\u00a0","DOI":"10.1136\/bmjopen-2019-031792"},{"key":"5985_CR25","doi-asserted-by":"crossref","unstructured":"Goulding A, Jones IE, Taylor RW, Manning PJ, Williams SM. More broken bones: a 4-year double cohort study of young girls with and without distal forearm fractures. J Bone Min Res. 2010;15(10):2011\u20138 Available from:\u00a0https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1359\/jbmr.2000.15.10.2011.\u00a0","DOI":"10.1359\/jbmr.2000.15.10.2011"},{"key":"5985_CR26","unstructured":"Africaid Zvandiri | Zimbabwe. \u00a0Available from: https:\/\/www.africaid-zvandiri.org\/.\u00a0[cited 2021 May 31]."},{"issue":"1","key":"5985_CR27","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1186\/s13063-017-2344-2","volume":"28","author":"C Gonzalez-Martinez","year":"2017","unstructured":"Gonzalez-Martinez C, Kranzer K, McHugh G, Corbett EL, Mujuru H, Nicol MP, et al. Azithromycin versus placebo for the treatment of HIV-associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial. Trials. 2017;28(1):18. https:\/\/doi.org\/10.1186\/s13063-017-2344-2.","journal-title":"Trials"},{"issue":"11","key":"5985_CR28","doi-asserted-by":"publisher","first-page":"374","DOI":"10.4172\/2155-6113.1000374","volume":"5","author":"SM Arpadi","year":"2014","unstructured":"Arpadi SM, Shiau S, Marx-Arpadi C, Yin MT. Bone health in HIV-infected children, adolescents and young adults: a systematic review. J AIDS Clin Res. 2014;5(11):374.","journal-title":"J AIDS Clin Res"},{"issue":"2","key":"5985_CR29","first-page":"59","volume":"18","author":"JL Casado","year":"2016","unstructured":"Casado JL. Renal and bone toxicity with the use of tenofovir: Understanding at the End. AIDS Rev. 2016;18(2):59\u201368.","journal-title":"AIDS Rev"},{"key":"5985_CR30","doi-asserted-by":"crossref","unstructured":"Avihingsanon A, Kerr SJ, Ramautarsing RA, Praditpornsilpa K, Sophonphan J, Ubolyam S, et al. The Association of Gender, Age, Efavirenz Use, and Hypovitaminosis D Among HIV-Infected Adults Living in the Tropics. AIDS Res Hum Retroviruses. \u00a02016;32(4):317\u201324. Available from: https:\/\/pubmed.ncbi.nlm.nih.gov\/26413903\/. [cited 2022 Apr 30].","DOI":"10.1089\/aid.2015.0069"},{"issue":"3","key":"5985_CR31","doi-asserted-by":"publisher","first-page":"678","DOI":"10.3945\/ajcn.111.024786","volume":"95","author":"SM Arpadi","year":"2012","unstructured":"Arpadi SM, McMahon DJ, Abrams EJ, Bamji M, Purswani M, Engelson ES, et al. Effect of supplementation with cholecalciferol and calcium on 2-y bone mass accrual in HIV-infected children and adolescents: a randomized clinical trial. Am J Clin Nutr. 2012;95(3):678\u201385. https:\/\/doi.org\/10.3945\/ajcn.111.024786.","journal-title":"Am J Clin Nutr"},{"key":"5985_CR32","doi-asserted-by":"crossref","unstructured":"Puthanakit T, Wittawatmongkol O, Poomlek V, Sudjaritruk T, Brukesawan C, Bunupuradah T, et al. Effect of calcium and vitamin D supplementation on bone mineral accrual among HIV-infected Thai adolescents with low bone mineral density. J Virus Erad. 2018;4(1):6\u201311.\u00a0Available from: https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5851189\/pdf\/jve-4-6.pdf>.","DOI":"10.1016\/S2055-6640(20)30234-X"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05985-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05985-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05985-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,22]],"date-time":"2024-07-22T20:02:30Z","timestamp":1721678550000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05985-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,26]]},"references-count":32,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["5985"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05985-0","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-624718\/v1","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1,26]]},"assertion":[{"value":"14 June 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 December 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 January 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Written informed consent in the local vernacular to participate in the trial will be obtained from guardians of all participants with written assent from participants aged below 18 years before enrolment. Participants aged 18 years or older and emancipated minors (those aged below 16 years who are married or have children) will be able to provide independent consent. The trial was approved by the Biomedical Research and Training Institute Institutional Review Board (reference AP158\/2020) on 10 May 2020, by the Harare Central Hospital Ethics committee on 18 May 2020 (reference HCHEC 030320\/12), by the London School of Hygiene and Tropical Medicine Ethics Committee (reference 22030) on 17 August 2020, by the Medical Research Council of Zimbabwe (reference A\/2626) on 17 December 2020 and by the University of Zambia Biomedical Research Ethics Committee (reference 1116-2020) on 17 August 2020. Approval for conducting the clinical trial and for importation of the study investigational products was obtained from the Medicines Control Authority of Zimbabwe (reference CT203\/2020) on 17 November 2020 and from the Zambia Medicines Regulatory Authority (reference CT103\/20) on 11 December 2020.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"78"}}