Consensus on Adolescent and Young Adult HIV Research Consent in Low- and Middle-Income Countries

Importance:

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.

Objective:

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.

Evidence Review:

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.

Findings:

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.

Conclusions and Relevance:

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.