Improving understanding of capacity to consent to sensitive HIV biomedical prevention research among adolescents and their parents or guardians in Rakai Uganda (ICARE): a quasi-experimental nonequivalent groups design protocol
Limited data are available on adolescents' actual capacity to consent, particularly in low-and middle-income countries and low resource, high HIV prevalence settings. Findings will contribute to addressing a major barrier to research participation through an examination of the capacity of adolescents to comprehend risks, benefits, and the other elements of informed consent and, therefore, to provide informed consent to biomedical research. ICARE has the potential to offer guidance for ethical boards seeking to harmonize adolescent treatment and prevention with research procedures, thus addressing a major barrier to adolescent research participation.
Authors
- Neema Nakyanjo (ORCID: https://orcid.org/0000-0002-1908-7957)
- Robert Ssekubugu (ORCID: https://orcid.org/0000-0003-1245-4774)
- John Santelli (ORCID: https://orcid.org/0000-0003-2768-1910)
- Betty Chan (ORCID: https://orcid.org/0000-0001-8265-3053)
- Susie Hoffman (ORCID: https://orcid.org/0000-0002-1870-4853)
- Mary A. Ott (ORCID: https://orcid.org/0000-0003-1347-2480)
- William Ddaaki (ORCID: https://orcid.org/0000-0002-2395-7003)
- David Serwadda (ORCID: https://orcid.org/0000-0001-6532-6587)
- Philip Kreniske (ORCID: https://orcid.org/0000-0002-1540-0651)
- Kirsty Sievwright (ORCID: https://orcid.org/0000-0002-7066-3841)
- Ying Wei (ORCID: https://orcid.org/0000-0002-7164-8109)
- Deborah E. Malden (ORCID: https://orcid.org/0000-0003-0567-8294)
- Gertrude Nakigozi (ORCID: https://orcid.org/0000-0001-6193-2790)
- Fred Nalugoda
- Tom Lutalo
- Godfrey Kigozi (ORCID: https://orcid.org/0009-0008-9142-6870)
- Holly Isenberg
Institutions
- Sacred Heart University (US)
- Columbia University Irving Medical Center (US)
- Institute for Family Health (US)
- Rakai Health Sciences Program (UG)
- Makerere University (UG)
- Columbia University (US)
- Icahn School of Medicine at Mount Sinai (US)
Publication Details
- Journal
- BMC Medical Ethics
- Published
- 2025-12-01
- DOI
- https://doi.org/10.1186/s12910-025-01342-x
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00