A transdisciplinary study of the ethical implications of adolescent enrollment in a clinical trial in The Gambia

In malaria endemic countries such as The Gambia, mass drug administration (MDA) is increasingly being used as a strategy for malaria elimination.1 Many studies have been or are in the process of being conducted to determine the most effective drugs and administration strategies. Further, mathematical modeling has shown that in order for MDA to be effective, at least 80% of the target population must comply with the complete drug regimen.2 At present, the literature provides evidence as to why adult participants may or may not take part in a malaria MDA trial. Reasons for participating include access to medical services that may otherwise be unavailable, an understanding of malaria as a health threat and the benefits of MDA, trust in the institution conducting the research, and the influence of other community members in favor of participation. Barriers to participating may include not being present at the time of the trial due to travel or work obligations, not understanding the MDA process (especially as to why asymptomatic individuals must still take the medication), not trusting the research institution, side effects of the medication (real or perceived), having a head of household forbid participation, or having to disclose the status of one’s pregnancy1,3–6 In addition, there is evidence that children and adolescents may be the most at risk for malaria in many settings.5,7 For example, in contrast to previous beliefs, a national report on malaria in The Gambia found that malaria prevalence was higher among children 5-14 years of age than those under 5.5 Yet, in a study by Dierickx, et al (2016), 64% of those who did not adhere to or comply with the completion of the MDA trial were minors.1 Whereas studies have been conducted on the participation of adults in MDA trials, there is a dearth of literature on the topic of minors’ enrollment, particularly in regard to their thoughts on and understanding of the MDA trial, decision-making process, and demographic-specific influences or barriers to participation.

Trefwoorden:B680-volksgezondheid

Project type:PhD project