The socio-cultural and ethical aspects of participation in a mass drug administration clinical trial for malaria elimination in The Gambia

Alexandra Elizabeth Thompson Fehr

Research output: ThesisDoctoral dissertation - Doctoral dissertation


Malaria is a social disease and has been a major public health concern for centuries. Since the 1950s, countless control, elimination, and eradication campaigns have taken place across the globe. After a general trend of decline since 2000, malaria case incidence and deaths have increased since 2019. As a result, a renewed focus on new or updated interventions to combat the disease has emerged. One such intervention is mass drug administration (MDA), the complete course of a given medication to an entire geographically defined target population, regardless of individual disease status. In order to be successful, at least 80% of those targeted for the MDA must take the medication as described, making the intervention highly dependent on social factors. By following a specific MDA clinical trial that took place in the Upper River Region of The Gambia, this study asks: How can we understand the socio-cultural and ethical aspects of participation in a mass drug administration trial for malaria elimination in The Gambia? To address these questions, this study used a mixed-methods, transdisciplinary approach while following MASSIV, a Phase III, community-based, cluster-randomized control trial that took place in 32 villages (16 control and 16 intervention) in 2018-2019. The first key finding of this dissertation is that the trial communities found participation to be more complex than what is measured in the traditional MDA indicators (e.g., coverage, compliance, and adherence). To them, participation in the MDA was a multidimensional concept, embedded within their social values and political structures. Respondents did not consider medicinal intake relevant for participation. Instead, participation was defined and practiced in myriad ways based upon one’s engagement with the MDA and involvement in its implementation. The second key finding is that the factors that affected participation – both facilitators and barriers – were not found within one level of the SEM, but instead were a combination of personal, interpersonal, communal, and/or societal factors operating at the same time. The pregnancy tests required for eligibility purposes and attendance at the sensitization meetings were two examples of, respectively, a barrier and facilitator to participation that crossed multiple levels of the SEM. Third, achieving the 80% coverage necessary for the MDA to be epidemiologically successful required work from the communities and from the trial fieldworkers. Trial villages were found to have internal strategies to increase participation independent of the trial team. However, the fieldworkers also practiced a type of work in navigating reciprocal relationships with the trial villages. These relationships were found to be essential in achieving MDA success, but also had implications on individual autonomy in the informed consent process and traditional research ethics. This study has implications for malaria control and elimination through MDA and for general research ethics and policy. First, it makes clear the importance of community participation and involvement with the MDA implementation. Second, by demonstrating the strong influence of familial and societal pressures on the decision-making process, especially when combined with components of structural coercion, this dissertation also demonstrates the importance of meaningful, bidirectional conversation between trial communities and trial implementers and treating informed consent as a continuous process contextualized to the specific setting. This study has demonstrated that participation in an MDA clinical trial for malaria elimination in The Gambia was a complex phenomenon influenced by multiple individual factors, social values, socio-political structures, and the greater environment. Overall, this study demonstrates the importance of using emic definitions and understandings of participation. Furthermore, it shows the need of the Global Health discipline to expand its epistemic community and incorporate other logics and philosophies into its implementation, practice, and policy.
Original languageEnglish
QualificationDoctor of Philosophy
Awarding Institution
  • Vrije Universiteit Amsterdam
  • Peeters, Koen, Supervisor
  • Zuiderent-Jerak, Teun, Supervisor, External person
  • Bunders-Aelen, Joske, Supervisor, External person
  • Badaji, Azucena, Supervisor, External person
Award date18-Nov-2022
Place of PublicationAmsterdam, the Netherlands
Publication statusPublished - 2022


  • B680-public-health


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