Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration, Kampala, Uganda.
Department of Global Health, University of Washington, Seattle, USA.
BMC Med Ethics. 2021 Sep 23;22(1):127. doi: 10.1186/s12910-021-00695-3.
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, 16-17-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.
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.
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.
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.
让少女参与生物医学艾滋病毒研究对于更好地了解新的预防干预措施在这一艾滋病毒感染高风险关键人群中的效果和安全性至关重要。然而，在让她们参与关键的生物医学研究之前，有许多伦理问题需要考虑。在乌干达，16-17 岁的青少年可以在没有父母同意的情况下获得性健康和生殖健康服务，包括艾滋病毒或其他性传播感染、避孕和产前护理。相比之下，参与涉及新研究药物的艾滋病毒预防研究需要青少年得到父母或监护人的同意。因此，隐私和保密问题可能会阻碍青少年的参与。我们描述了社区对在乌干达参与 MTN 034 研究的少女的伦理考虑因素的看法。
从 2017 年 8 月到 2018 年 3 月，我们在坎帕拉举行了五次利益攸关方参与会议，为 MTN 034 研究做准备（NCT03593655）：两次有 140 名社区代表参加，两次有 125 名青少年参加，一次有 50 名青少年和家长参加。讨论由研究小组主持。会议记录由记录员记录。总结说明描述了社区对青少年参与艾滋病毒研究的看法，包括一致、分歧或少数派的观点、挑战和提出的解决方案。
大多数社区成员认为父母或监护人的同意是参与研究的主要障碍，因为他们担心青少年会无意中向父母透露婚前性行为，这是一种文化禁忌。在 125 名青少年参与者中，有 119 名（95%）担心无意中向父母透露性活动。社区利益攸关方确定了在艾滋病毒生物医学研究中让青少年参与的关键伦理考虑因素：（1）让关键利益攸关方参与招募，（2）确保青少年性行为的敏感信息保密，（3）告知青少年要向父母或监护人透露的信息，（4）通过受过适当培训的工作人员提供青年友好服务，（5）与社区青年组织合作，最大限度地招募和留住青少年。
在进行青少年艾滋病毒预防研究之前，与不同的社区代表进行利益攸关方的参与对于共同塑造研究议程、成功招募和留住艾滋病毒临床试验中的青少年以及确定在试验实施过程中确保高标准伦理的实际策略至关重要。
