{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T15:32:44Z","timestamp":1769268764822,"version":"3.49.0"},"reference-count":11,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,10,30]],"date-time":"2020-10-30T00:00:00Z","timestamp":1604016000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,10,30]],"date-time":"2020-10-30T00:00:00Z","timestamp":1604016000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001713","name":"European and Developing Countries Clinical Trials Partnership","doi-asserted-by":"publisher","award":["RIA2016MC-1616 CHAPS RIA2016MC"],"award-info":[{"award-number":["RIA2016MC-1616 CHAPS RIA2016MC"]}],"id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>HIV remains a major public health issue, especially in Eastern and Southern Africa. Pre-exposure prophylaxis is highly effective when adhered to, but its effectiveness is limited by cost, user acceptability and uptake. The cost of a non-inferiority phase III trial is likely to be prohibitive, and thus, it is essential to select the best possible drug, dose and schedule in advance. The aim of this study, the Combined HIV Adolescent PrEP and Prevention Study (CHAPS), is to investigate the drug, dose and schedule of pre-exposure prophylaxis (PrEP) required for the protection against HIV and the acceptability of PrEP amongst young people in sub-Saharan Africa, and hence to inform the choice of intervention for future phase III PrEP studies and to improve strategies for PrEP implementation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We propose a mixed-methods study amongst young people aged 13\u201324\u2009years. The first component consists of qualitative research to identify the barriers and motivators towards the uptake of PrEP amongst young people in South Africa, Uganda and Zimbabwe. The second component is a randomised clinical trial (ClinicalTrials.gov NCT03986970, June 2019) using a novel ex vivo HIV challenge method to investigate the optimal PrEP treatment (FTC-TDF vs FTC-TAF), dose and schedule. We will recruit 144 amongst HIV-negative uncircumcised men aged 13\u201324\u2009years from voluntary male medical circumcision clinics in two sites (South Africa and Uganda) and randomise them into one of nine arms. One group will receive no PrEP prior to surgery; the other arms will receive either FTC-TDF or FTC-TAF, over 1 or 2\u00a0days, and with the final dose given either 6 or 20\u2009h prior to surgery. We will conduct an ex vivo HIV challenge on their resected foreskin tissue.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>This study will provide both qualitative and quantitative results to help decide the optimum drug, dose and schedule for a future phase III trial of PrEP. The study will also provide crucial information on successful strategies for providing PrEP to young people in sub-Saharan Africa.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>ClinicalTrials.gov<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03986970\">NCT03986970<\/jats:ext-link>. Registered on 14 June 2019<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13063-020-04760-x","type":"journal-article","created":{"date-parts":[[2020,10,30]],"date-time":"2020-10-30T05:10:58Z","timestamp":1604034658000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa\u2014study protocol for a mixed-methods study including a randomised controlled trial"],"prefix":"10.1186","volume":"21","author":[{"name":"on behalf of the CHAPS team","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Nash","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Dietrich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A. 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Qualitative research practice: a guide for social science students and researchers. 2nd ed: Sage Publishing; 2013. https:\/\/uk.sagepub.com\/en-gb\/eur\/qualitative-research-practice\/book237434 ."},{"issue":"6997","key":"4760_CR11","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1136\/bmj.311.6997.109","volume":"311","author":"N Mays","year":"1995","unstructured":"Mays N, Pope C. Rigour and qualitative research. BMJ. 1995;311(6997):109\u201312.","journal-title":"BMJ"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04760-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-020-04760-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04760-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,11,25]],"date-time":"2022-11-25T18:58:09Z","timestamp":1669402689000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-020-04760-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,30]]},"references-count":11,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["4760"],"URL":"https:\/\/doi.org\/10.1186\/s13063-020-04760-x","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10,30]]},"assertion":[{"value":"20 May 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 September 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 October 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Ethical approval was granted from the University of Cape Town (290\/2018), the University of the Witwatersrand (180906B, M1811148 and 180108), the Uganda National Council for Science and Technology (HS2534), the Uganda National Drug Authority (CTA0112) and the Medical Research Council of Zimbabwe (MRCZ\/A\/2356), and central ethical approval has been confirmed from the London School of Hygiene and Tropical Medicine (15629 and 16182). Signed informed consent was required from all participants prior to enrolment. For social science participants under 18, a waiver of consent has been granted by ethics boards in Cape Town (290\/2018, letter dated 18 July 2018) and Zimbabwe (as part of the initial submission, MRCZ\/A\/2356). For Entebbe, the Uganda National Council for Science and Technology 2014 guidelines (\u201cNational guidelines for research involving humans as research participants\u201d) permit those aged 14\u201317 to consent to participate without the need for parental approval.The study sponsor is the Perinatal HIV Research Unit, Johannesburg, South Africa, and the principal investigator is Neil A Martinson. Key protocol modifications will be communicated from the sponsor to relevant parties in a timely manner.","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":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"900"}}