In many regions around the world, those at highest risk for acquiring HIV are young adults and adolescents. Young men who have sex with men in the USA are the group at greatest risk for HIV acquisition, particularly if they are part of a racial or ethnic minority group.1 Adolescent girls and young women have the highest incidence rates of any demographic subgroup in sub-Saharan Africa.2 To reverse the global AIDS pandemic’s toll on these high-risk groups, it is important to (...) deploy the most effective HIV prevention tools to young MSM in the USA, to adolescent girls and young women in sub-Saharan Africa, and to any other adolescents and young adults at high risk for HIV as products are proven to be safe and efficacious. Although prevention interventions with proven efficacy, such as oral pre-exposure prophylaxis, are available,3–8 they have not been sufficient to stem the tide and an expanded prevention toolkit is urgently needed to serve these populations. The field of HIV prevention continues to identify promising leads in the development of new biomedical prevention products, either delivering antiviral drug topically or systemically. The dapivirine ring has been shown to provide modest protection and is currently being tested in open label studies while injectable cabotegravir is being tested in a large efficacy trial for preventing HIV acquisition. Advances in the field of HIV prevention mean that scientists and regulators must plan for how they will bring prevention tools to populations at high risk for HIV as they conduct efficacy and effectiveness trials. For instance, safety data from younger age groups can also be used in combination with efficacy data from adult studies, where appropriate, as bridging studies to expand labelling to younger ages. If these …. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 22-23, June 2011.

The American Journal of Bioethics, Volume 11, Issue 6, Page 21-22, June 2011.

BackgroundInvolvement 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.MethodsFrom 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.ResultsMost 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.ConclusionsStakeholder 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. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page W1-W3, June 2011.