Enrolling Adolescents in Research on HIV and Other Sensitive Issues: Lessons from South Africa

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With more than 6 million HIV positive individuals—the highest of any country in the world—South Africa is the epicentre of the HIV/AIDS pandemic. In much of sub-Saharan Africa, especially South Africa, the HIV/AIDS epidemic is growing fastest in teenagers, especially young girls (see sidebar) [1]. Hence, any future vaccination strategy in this setting will, of necessity, have to target young adolescents prior to sexual debut. The current candidate HIV vaccines that are being considered for efficacy trials are likely to act principally by reducing viral loads, hence reducing both transmission to sexual partners and progression to AIDS [2]. One of the limitations to conducting HIV vaccine trials is the dearth of data on important HIV disease parameters such as viral load, immune responses, and disease progression in African adolescents. While there is observational research currently being conducted in the United States on adolescents, such as the Reaching for Excellence in Adolescent Care and Health (REACH) study [3], there is a need for information on set point, HIV transmission, and disease progression in adolescents from Africa, even if only to confirm whether the disease process in African adolescents differs from those in developed countries. The Joint United Nations Programme on HIV/AIDS notes that children, including infants and adolescents, should be eligible for enrolment in HIV preventive vaccine trials, both as a matter of equity and because young adolescents and children are at high risk of HIV infection [4]. However, no distinction is drawn between adolescent participation with parental consent and the autonomous participation of adolescents. This distinction is particularly important in sub-Saharan Africa, where it is often difficult or impossible to obtain parental consent. The Centre for the AIDS Programme of Research in South Africa (CAPRISA), which is funded by the US National Institutes of Health, recently proposed a follow-up study of adolescents and young adults with acute HIV infection to obtain the essential information on subtype C viral set point, prognostic viral load measurements, and disease outcome—all important biological outcome markers in HIV vaccine efficacy trials. The study proposed to enrol, as one of its groups, adolescents as young as 14 years old from a prenatal and family planning clinic, where those who volunteered could do so without parental consent when parents or legal guardians were not available. Three ethics committees supported the enrolment of this cohort, although a fourth did not. As a result, the study protocol was amended to include participants only above the age of 18. Several works have highlighted the ethico-legal challenges implicit in enrolling adolescents in South African HIV vaccine trials [5–7]. However, the enrolment of autonomous adolescents in crucial HIV observational studies and in other types of sensitive non-HIV research in South Africa is equally problematic. We present the ethico-legal challenges, as well as the scientific and social grounds, to justify the autonomous participation of adolescents in HIV observational studies—such as the CAPRISA study—as well as in future HIV vaccine trials in South Africa and much of the rest of sub-Saharan Africa. We argue that the same reasoning applies to other types of sensitive non-HIV research involving adolescents. We also suggest how conflicts between restrictive laws and flexible ethics guidelines should be addressed.