Day Suzanne, Shah Sonam J, Onyeama Ujunwa F, Fidelak Lauren, Nwaozuru Ucheoma, Rennie Stuart, Babatunde Abdulhammed Opeyemi, Tang Weiming, Rousseau Elzette, Obiezu-Umeh Chisom, Chima Kelechi Prince, Sam-Agudu Nadia A, Wilson Erin C, Shah Seema K, Nkengasong Susan, Gbaja-Biamila Titilola, Kapogiannis Bill G, Bekker Linda-Gail, Iwelunmor Juliet, Ezechi Oliver, Tucker Joseph D
Department of Medicine, Division of Infectious Diseases, University of North Carolina at Chapel Hill.
Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill.
JAMA Netw Open. 2025 Apr 1;8(4):e257879. doi: 10.1001/jamanetworkopen.2025.7879.
Many adolescents and young adults (AYAs) in low- and middle-income countries (LMICs) are excluded from HIV research because of challenges with informed consent for study participation, which makes it difficult to understand and improve the lives of AYAs living with HIV and AIDS in a wide variety of settings.
To help increase the inclusion of AYAs in HIV research, we developed a consensus statement on practical strategies for improving AYA consent in HIV research in LMICs.
The VOICE (HIV Youth Informed Consent & Ethics in Research) Working Group included AYAs, researchers, community organizers, advocates, research ethics committee members, parents of AYAs, and bioethicists who drafted initial statement items using data from a global open call and scoping review. An adapted Delphi process was then used to develop consensus statement items. The process involved 3 rounds of online Likert-scale questionnaires and a hybrid (online and in-person) consensus summit in Lagos, Nigeria, in 2022, with the total study period lasting from August 23, 2021, to February 10, 2023.
Thirty-five people participated in the final round of the Delphi process, including 14 individuals younger than 35 years (40.0%), 25 HIV researchers (71.4%), and 32 people who worked in an LMIC (91.4%). Twenty-five items reached a predefined threshold for consensus (≥80% agreement). Strong consensus emerged for formal mechanisms (eg, cocreation, crowdsourcing, or youth advisory boards) for AYA engagement in and education about research as well as for strategies to enhance parental and guardian involvement in HIV research when safe and appropriate. Capacity strengthening can allow AYAs to review research protocols, join ethical review committees, and advocate for regulatory change. Two items in the statement (alternatives to parental consent and raising awareness among research ethics committees about AYA-independent consent) required further refinement to reach the agreement threshold for inclusion.
Greater engagement of both AYAs and parents may help to enhance consent processes and increase the inclusion of AYAs in LMIC HIV research studies. The resulting consensus statement provides practical strategies for implementing improved consent processes for AYA research participation at the organizational, community, and policy levels, which may help foster greater inclusion of AYAs in HIV research and address existing data gaps.
由于参与研究的知情同意存在挑战，许多低收入和中等收入国家（LMICs）的青少年和青年成年人（AYAs）被排除在HIV研究之外，这使得了解和改善生活在各种环境中的感染HIV和艾滋病的AYAs的生活变得困难。
为了帮助增加AYAs参与HIV研究的比例，我们针对改善LMICs中HIV研究的AYA同意程序的实际策略制定了一份共识声明。
VOICE（HIV青年研究知情同意与伦理）工作组包括AYAs、研究人员、社区组织者、倡导者、研究伦理委员会成员、AYAs的父母和生物伦理学家，他们利用全球公开征集和范围审查的数据起草了初始声明项目。然后采用了一种改编的德尔菲法来制定共识声明项目。该过程包括三轮在线李克特量表问卷以及2022年在尼日利亚拉各斯举行的一次混合（在线和面对面）共识峰会，整个研究期从2021年8月23日持续到2023年2月10日。
35人参与了德尔菲法的最后一轮，包括14名35岁以下的个体（40.0%）、25名HIV研究人员（71.4%）以及32名在LMIC工作的人员（91.4%）。25个项目达到了预先定义的共识阈值（≥80%的一致同意）。对于AYA参与研究和接受研究教育的正式机制（如共同创造、众包或青年咨询委员会）以及在安全且合适的情况下加强父母和监护人参与HIV研究的策略，出现了强烈共识。能力建设可以使AYAs审查研究方案、加入伦理审查委员会并倡导监管变革。声明中的两个项目（父母同意的替代方案以及提高研究伦理委员会对AYA独立同意的认识）需要进一步完善以达到纳入的一致同意阈值。
AYAs和父母更多地参与可能有助于加强同意程序，并增加AYAs参与LMIC的HIV研究。由此产生的共识声明提供了在组织、社区和政策层面实施改进的AYA研究参与同意程序的实际策略，这可能有助于促进AYAs更多地参与HIV研究并解决现有的数据差距。
