About 40% of HIV-infected children in Zimbabwe are orphaned. The main ethical problem with including them in the ARROW trial of antiretroviral therapy is that the relatives who act as informal guardians are not normally registered as legal guardians and so could not give consent for children's inclusion; this was solved by the Zimbabwean institutional review board waiving the requirement for consent from a legal guardian. Guardians were asked to sign an affidavit indicating that they understood the level of caregiver commitment required. Practical problems arose because orphaned children may change caregiver from time to time, which can reduce drug adherence, clinic attendance and confidentiality. These problems are addressed by supplying pill-boxes to help with the correct administration of medication, using home visitors and counsellors to advise children and caregivers, and establishing a support group for orphans and other HIV-infected children.
Bwakura-Dangarembizi, M.F.; Musiime, V.; Bakeera-Kitaka, S.; Hahirya-Ntege, P.; Crawley, J.; Mugyenyi, P.; Musoke, P.; Munderi, P.; Thomason, M.; Kekitiinwa, A.; Nathoo, K.; ARROW trial team. Ethical and practical constraints to the participation of HIV-infected orphaned children in a clinical trial in Zimbabwe. Experiences from the AntiRetroviral Research for Watoto (ARROW) Trial. Presented at AIDS 2008 – XVII International AIDS Conference, Mexico City, Mexico, 3-8 August 2008. (2008)