{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T03:54:42Z","timestamp":1792641282333,"version":"4.5.0"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,9,23]],"date-time":"2021-09-23T00:00:00Z","timestamp":1632355200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,9,23]],"date-time":"2021-09-23T00:00:00Z","timestamp":1632355200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000061","name":"Fogarty International Center","doi-asserted-by":"publisher","award":["K43 TW010695"],"award-info":[{"award-number":["K43 TW010695"]}],"id":[{"id":"10.13039\/100000061","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Ethics"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Involvement of adolescent girls in biomedical HIV research is essential to better understand efficacy and safety of new prevention interventions in this key population at high risk of HIV infection. However, there are many ethical issues to consider prior to engaging them in pivotal biomedical research. In Uganda, 16\u201317-year-old adolescents can access sexual and reproductive health services including for HIV or other sexually transmitted infections, contraception, and antenatal care without parental consent. In contrast, participation in HIV prevention research involving investigational new drugs requires adolescents to have parental or guardian consent. Thus, privacy and confidentiality concerns may deter adolescent participation. We describe community perspectives on ethical considerations for involving adolescent girls in the MTN 034 study in Uganda.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>From August 2017 to March 2018, we held five stakeholder engagement meetings in preparation for the MTN 034 study in Kampala, Uganda (NCT03593655): two with 140 community representatives, two with 125 adolescents, and one with 50 adolescents and parents. Discussions were moderated by the study team. Proceedings were documented by notetakers. Summary notes described community perspectives of adolescent participation in HIV research including convergent, divergent or minority views, challenges, and proposed solutions.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Most community members perceived parental or guardian consent as a principal barrier to study participation due to concerns about adolescent disclosure of pre-marital sex, which is a cultural taboo.  Of 125 adolescent participants, 119 (95%) feared inadvertent disclosure of sexual activity to their parents. Community stakeholders identified the following critical considerations for ethical involvement of adolescents in HIV biomedical research: (1) involving key stakeholders in recruitment, (2) ensuring confidentiality of sensitive information about adolescent sexual activity, (3) informing adolescents about information to be disclosed to parents or guardians, (4) offering youth friendly services by appropriately trained staff, and (5) partnering with community youth organizations to maximize recruitment and retention.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Stakeholder engagement with diverse community representatives prior to conducting adolescent HIV prevention research is critical to collectively shaping the research agenda, successfully recruiting and retaining adolescents in HIV clinical trials and identifying practical strategies to ensure high ethical standards during trial implementation.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12910-021-00695-3","type":"journal-article","created":{"date-parts":[[2021,9,23]],"date-time":"2021-09-23T12:06:01Z","timestamp":1632398761000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Ethical considerations for involving adolescents in biomedical HIV prevention research"],"prefix":"10.1186","volume":"22","author":[{"given":"Rita","family":"Nakalega","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyne","family":"Akello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brenda","family":"Gati","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clemensia","family":"Nakabiito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Nolan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Betty","family":"Kamira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juliane","family":"Etima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teopista","family":"Nakyanzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doreen","family":"Kemigisha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie C.","family":"Nanziri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stella","family":"Nanyonga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Janine","family":"Nambusi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmie","family":"Mulumba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florence","family":"Biira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hadijah Kalule","family":"Nabunya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon Afrika","family":"Akasiima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joselyne","family":"Nansimbe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Maena","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juliet Allen","family":"Babirye","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Ngure","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Mujugira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,9,23]]},"reference":[{"key":"695_CR1","unstructured":"UNAIDS. Global AIDS update. Seizing the moment: tackling entrenched inequalities to end epidemics. 2020."},{"key":"695_CR2","unstructured":"UNICEF. Synthesis report of the rapid assessment of adolescent and HIV programme context in five countries: Botswana, Cameroon, Jamaica, Swaziland and Zimbabwe. In: All in to end adolescent AIDS. 2015. http:\/\/www.childrenandaids.org\/node\/752. Accessed 21 July 20."},{"issue":"10","key":"695_CR3","doi-asserted-by":"publisher","first-page":"1461","DOI":"10.1097\/qad.0000000000001506","volume":"31","author":"R Schaefer","year":"2017","unstructured":"Schaefer R, Gregson S, Eaton JW, Mugurungi O, Rhead R, Takaruza A, et al. Age-disparate relationships and HIV incidence in adolescent girls and young women: evidence from Zimbabwe. Aids. 2017;31(10):1461\u201370. https:\/\/doi.org\/10.1097\/qad.0000000000001506.","journal-title":"Aids"},{"issue":"9734","key":"695_CR4","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1016\/s0140-6736(10)60548-x","volume":"376","author":"RK Jewkes","year":"2010","unstructured":"Jewkes RK, Dunkle K, Nduna M, Shai N. Intimate partner violence, relationship power inequity, and incidence of HIV infection in young women in South Africa: a cohort study. Lancet. 2010;376(9734):41\u20138. doi:https:\/\/doi.org\/10.1016\/s0140-6736(10)60548-x.","journal-title":"Lancet"},{"key":"695_CR5","unstructured":"WHO. Consolidated guideline on sexual and reproductive health and rights of women living with HIV: executive summary. World Health Organization. 2017. https:\/\/www.who.int\/reproductivehealth\/publications\/gender_rights\/Ex-Summ-srhr-women-hiv\/en\/. Accessed 21 July 20."},{"key":"695_CR6","unstructured":"UNAIDS. Women lead change happens: women advancing the end of AIDS. Joint United Nations Programme on HIV\/AIDS. 2017. https:\/\/genderandaids.unwomen.org\/en\/resources\/2017\/03\/when-women-lead-change-happens. Accessed 19 July 20."},{"key":"695_CR7","unstructured":"WHO. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. World Health Organization. 2016. https:\/\/www.who.int\/hiv\/pub\/arv\/arv-2016\/en\/. Accessed 22 July 20."},{"issue":"Suppl 1","key":"695_CR8","doi-asserted-by":"publisher","first-page":"S12","DOI":"10.1097\/QAI.0b013e3181e1e2c0","volume":"54","author":"RJ Di Clemente","year":"2010","unstructured":"Di Clemente RJ, Sales JM, Borek N. Barriers to adolescents\u2019 participation in HIV biomedical prevention research. J Acquir Immune Deficiency Syndromes. 2010;54(Suppl 1):S12.","journal-title":"J Acquir Immune Deficiency Syndromes."},{"key":"695_CR9","unstructured":"de Almeida RA, Lins L, Rocha ML. Ethical and bioethical dilemmas in adolescent health care. 2015."},{"issue":"3","key":"695_CR10","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1111\/dewb.12061","volume":"15","author":"MO Folayan","year":"2015","unstructured":"Folayan MO, Haire B, Harrison A, Odetoyingbo M, Fatusi O, Brown B. Ethical issues in adolescents\u2019 sexual and reproductive health research in Nigeria. Dev World Bioethics. 2015;15(3):191\u20138.","journal-title":"Dev World Bioethics"},{"issue":"5","key":"695_CR11","doi-asserted-by":"publisher","first-page":"576","DOI":"10.1016\/j.jadohealth.2016.01.007","volume":"58","author":"LF Hoffman","year":"2016","unstructured":"Hoffman LF, Francis NK, Catallozzi M, Francis JK, Stanberry LR, Rosenthal SL. Inclusion of adolescents in clinical trials for sexually transmitted infections: a review of existing registered studies. J Adolescent Health. 2016;58(5):576\u20138.","journal-title":"J Adolescent Health"},{"key":"695_CR12","doi-asserted-by":"publisher","first-page":"19149","DOI":"10.7448\/IAS.17.3.19149","volume":"17","author":"EE Tolley","year":"2014","unstructured":"Tolley EE, Kaaya S, Kaale A, Minja A, Bangapi D, Kalungura H, et al. Comparing patterns of sexual risk among adolescent and young women in a mixed-method study in Tanzania: implications for adolescent participation in HIV prevention trials. J Int AIDS Soc. 2014;17:19149.","journal-title":"J Int AIDS Soc"},{"issue":"3","key":"695_CR13","doi-asserted-by":"publisher","first-page":"299","DOI":"10.1037\/cpp0000209","volume":"6","author":"SL Rosenthal","year":"2018","unstructured":"Rosenthal SL, Morris MC, Hoffman LF, Zimet GD. Inclusion of adolescents in STI\/HIV biomedical prevention trials: autonomy, decision making, and parental involvement. Clin Pract Pediatr Psychol. 2018;6(3):299.","journal-title":"Clin Pract Pediatr Psychol"},{"key":"695_CR14","unstructured":"U.S. Department of Health & Human Services OfHRP. Special Protections for Children as Research Subjects. 2016. https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/special-protections-for-children\/index.html Accessed 30 June 2020."},{"key":"695_CR15","volume-title":"Adolescent sexual and reproductive health in Uganda: a synthesis of research evidence","author":"S Neema","year":"2004","unstructured":"Neema S, Musisi N, Kibombo R. Adolescent sexual and reproductive health in Uganda: a synthesis of research evidence. New York: Alan Guttmacher Institute; 2004."},{"issue":"1","key":"695_CR16","doi-asserted-by":"publisher","first-page":"S7-S14","DOI":"10.1016\/j.jadohealth.2014.09.011","volume":"56","author":"J Svanemyr","year":"2015","unstructured":"Svanemyr J, Amin A, Robles OJ, Greene ME. Creating an enabling environment for adolescent sexual and reproductive health: a framework and promising approaches. J Adolescent Health. 2015;56(1):S7\u201314.","journal-title":"J Adolescent Health"},{"key":"695_CR17","unstructured":"Uganda National Council of Science and Technology. National guidelines for research involving humans as research participants. Kampala-Uganda: UNCST2007."},{"issue":"7","key":"695_CR18","doi-asserted-by":"publisher","first-page":"180","DOI":"10.1371\/journal.pmed.0030180","volume":"3","author":"JA Singh","year":"2006","unstructured":"Singh JA, Karim SSA, Karim QA, Mlisana K, Williamson C, Gray C, et al. Enrolling adolescents in research on HIV and other sensitive issues: lessons from South Africa. PLoS Med. 2006;3(7):180.","journal-title":"PLoS Med"},{"issue":"10","key":"695_CR19","doi-asserted-by":"publisher","first-page":"887","DOI":"10.1136\/archdischild-2014-306444","volume":"99","author":"N Modi","year":"2014","unstructured":"Modi N, Vohra J, Preston J, Elliott C, Van\u2019t Hoff W, Coad J, et al. Guidance on clinical research involving infants, children and young people: an update for researchers and research ethics committees. Arch Dis Childhood. 2014;99(10):887\u201391.","journal-title":"Arch Dis Childhood"},{"key":"695_CR20","unstructured":"UNAIDS and AVAC. The good participatory practice guidelines for biomedical HIV prevention trials (GPP), 2nd edition. 2011."},{"issue":"1","key":"695_CR21","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1016\/j.jadohealth.2007.07.017","volume":"42","author":"S Flicker","year":"2008","unstructured":"Flicker S, Guta A. Ethical approaches to adolescent participation in sexual health research. J Adolescent Health. 2008;42(1):3\u201310.","journal-title":"J Adolescent Health"},{"key":"695_CR22","unstructured":"World Health Organization. Guidance on ethical considerations in planning and reviewing research studies on sexual and reproductive health in adolescents. 2018. https:\/\/www.who.int\/reproductivehealth\/publications\/adolescence\/ethical-considerations-srh-research-in-adolescents\/en\/. Accessed 22 July 20"},{"issue":"1","key":"695_CR23","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s12887-017-0869-x","volume":"17","author":"P Grootens-Wiegers","year":"2017","unstructured":"Grootens-Wiegers P, Hein IM, van den Broek JM, de Vries MC. Medical decision-making in children and adolescents: developmental and neuroscientific aspects. BMC Pediatrics. 2017;17(1):1\u201310.","journal-title":"BMC Pediatrics"},{"key":"695_CR24","unstructured":"Graham A, Powell MA, Anderson D, Fitzgerald R, Taylor NJ. Ethical research involving children. UNICEF Office of Research-Innocenti Florence; 2013."},{"issue":"1","key":"695_CR25","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/1472-6939-8-5","volume":"8","author":"C Slack","year":"2007","unstructured":"Slack C, Strode A, Fleischer T, Gray G, Ranchod C. Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa. BMC Med Ethics. 2007;8(1):1\u20138.","journal-title":"BMC Med Ethics"},{"issue":"1","key":"695_CR26","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1186\/1472-6939-8-5","volume":"8","author":"C Slack","year":"2007","unstructured":"Slack C, Strode A, Fleischer T, Gray G, Ranchod C. Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa. BMC Med Ethics. 2007;8(1):5.","journal-title":"BMC Med Ethics"},{"issue":"1","key":"695_CR27","doi-asserted-by":"publisher","first-page":"58","DOI":"10.1179\/2046905514Y.0000000152","volume":"36","author":"L Collins","year":"2016","unstructured":"Collins L, Ellis M, Pritchard EW, Jenkins C, Hoeritzauer I, Farquhar A, et al. Child-headed households in Rakai District, Uganda: a mixed-methods study. Paediatrics Int Child Health. 2016;36(1):58\u201363.","journal-title":"Paediatrics Int Child Health"}],"container-title":["BMC Medical Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12910-021-00695-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12910-021-00695-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12910-021-00695-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,9,23]],"date-time":"2021-09-23T12:06:38Z","timestamp":1632398798000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmedethics.biomedcentral.com\/articles\/10.1186\/s12910-021-00695-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,23]]},"references-count":27,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["695"],"URL":"https:\/\/doi.org\/10.1186\/s12910-021-00695-3","relation":{},"ISSN":["1472-6939"],"issn-type":[{"value":"1472-6939","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9,23]]},"assertion":[{"value":"30 March 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 September 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 September 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Approval to conduct this study was provided by the Joint Clinical Research Council, Uganda National Council for Science and Technology (HS2314), National Drug Authority (CTA 0044), and Johns Hopkins Medicine Institutional Review Boards (JHMIRB IRB00154539).  Informed consent from all the participating stakeholders including legally authorized guardians or parents of the minor participants and minors that participated in the study was obtained.  All methods were performed in accordance with the relevant guidelines and regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"127"}}