Consensus on Adolescent and Young Adult HIV Research Consent in Low- and Middle-Income Countries
Year: 2025
Type: article
Abstract: 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.
Source: JAMA Network Open
Authors: Suzanne Day, Sonam J. Shah, Ujunwa F. Onyeama, Lauren Fidelak, Ucheoma Nwaozuru, Stuart Rennie, Abdulhammed Opeyemi Babatunde, Weiming Tang, Elzette Rousseau, Chisom Obiezu-Umeh, Kelechi Prince Chima, Nadia A. Sam-Agudu, Erin C. Wilson, Seema K. Shah, Susan Nkengasong, Titilola Gbaja-Biamila, Bill G. Kapogiannis, Linda-Gail Bekker, Juliet Iwelunmor, Oliver Ezechi, Joseph D. Tucker
Institutions: University of North Carolina at Chapel Hill, Northwestern University, Lurie Children's Hospital, Wake Forest University Health Sciences, Wake Forest University, University of Ibadan, University of Cape Town, Saint Louis University, Nigerian Institute of Medical Research, University of Minnesota, University of Cape Coast, Institute of Human Virology, San Francisco Department of Public Health, London School of Hygiene & Tropical Medicine, United States Department of Health and Human Services, National Institutes of Health
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,000
Funders: Gilead Sciences, ViiV Healthcare, National Institutes of Health, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, Office of Behavioral and Social Sciences Research, National Institute on Minority Health and Health Disparities, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Awards: G121663281, G162929154, CombinADO: a combination intervention strategy to improve health outcomes for adolescents living with HIV, G3547625325, G3559084, G3624624647, G4279700436, G4453626146, G4621079379, G5209895998, Developing and Testing a Multi-level Package of Interventions for an Integrated Care Delivery Model of HIV Prevention and Treatment Targeting Adolescent Girls in Zambia, G5762365032, G6552203266, Intensive Combination Approach to Rollback the Epidemic (iCARE) in Nigerian Adolescents, G6702937576, G6809474626, Strategic antiretroviral therapy and HIV testing for youth in rural Africa (SATURN), G7386367918, Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes, G7735233169, G7872006542, G8312849344, G8418400573, G8454162667, G8926678094, G9000089005, G9000111879, G9000317795, Mentoring Multidisciplinary Global HIV Patient-oriented research
OpenAlex ID: W4409920610