(P153) Developing Consensus on Improving Adolescent and Young Adult Informed Consent in HIV Research in Low- and Middle-Income Countries: Results of A Modified Delphi Process

Background: Adolescents and young adults (AYA, age 10-24 years) face unique ethical, social, structural, and legal challenges with informed consent to research participation, resulting in systematic AYA exclusion from HIV prevention and treatment studies. We describe the development of a stakeholder-driven consensus statement on strategies for improving AYA informed consent to HIV research participation in low- and middle-income countries (LMICs).

Methods: The VOICE (HIV YOuth Informed Consent & Ethics in Research) Working Group brought together a diverse, multi-disciplinary team of young people, HIV/AYA researchers, community organizers, advocates, research ethics committee members, and bioethicists. The Working Group initially drafted statement items drawing on themes identified in a previous open call, supplemented with a scoping review. We then implemented an adapted Delphi process consisting of two rounds of online survey questionnaires and a hybrid (online and in-person) consensus summit in Lagos, Nigeria. The questionnaire used Likert scale responses to measure agreement on whether to include each statement item and textboxes for feedback.

Results: Consensus survey round one was sent to VOICE Working Group members and affiliates of a multinational research consortium focused on AYA HIV research. Of the 53 invitees, 44 completed the survey (83%). All 27 initial statement items achieved consensus, defined as ≥80% of participants responding “agree” or “strongly agree” to an item’s inclusion in the statement. Round one results were brought to a hybrid consensus summit for discussion and further revision, condensing to 26 items. The resulting revised statement items were then used in survey round two, completed online by 73 consensus summit participants. Of the 26 items, 23 achieved consensus. All three items with < 80% agreement pertained to parental involvement in consent processes. While there was considerable tension about whether and how to waive parental consent, feedback also indicated support for alternatives to parental consent.

Conclusion: While parental involvement in AYA consent is a contentious point, there is widespread agreement among key stakeholders on actionable strategies to improve AYA consent processes, and thereby increase AYA inclusion in HIV research in LMICs. The resulting consensus statement provides practical guidance for implementation at the organizational, community, and policy levels.