From informed consent to adherence: factors influencing involvement in mass drug administration with ivermectin for malaria elimination in The Gambia.

BACKGROUND: The World Health Organization (WHO) recommends consideration of mass drug administration (MDA) for malaria control in low-endemic settings approaching elimination. However, MDA remains a controversial strategy, as multiple individual, social, and operational factors have shown to affect its acceptability at local levels. This is further complicated by inconsistent definitions of key indicators derived from individual and community involvement-coverage, adherence, and compliance-that cast doubts about the actual and potential epidemiological impact of MDA on disease control and elimination. This study aimed to identify limitations and enabling factors impacting involvement at different stages of a large cluster-randomized trial assessing the effect of combining dihydroartemisinin-piperaquine (DP) and ivermectin (IVM) in malaria transmission in The Gambia. METHODS: This social science study used a mixed-methods approach. Qualitative data were collected in intervention and control villages through ethnographic methods, including in-depth interviews (IDIs), focus group discussions (FGDs), and participant observation conducted with trial participants and decliners, community leaders, and field staff. A cross-sectional survey was conducted in the intervention villages after the first year of MDA. Both strands of the study explored malaria knowledge and opinions, social dynamics influencing decision-making, as well as perceived risks, burdens, and benefits associated with this MDA. RESULTS: 157 IDIs and 11 FGDs were conducted, and 864 respondents were included in the survey. Barriers and enabling factors to involvement were differentially influential at the various stages of the MDA. Issues of social influence, concerns regarding secondary effects of the medication, costs associated with malaria, and acceptability of the implementing organization, among other factors, differently affected the decision-making processes throughout the trial. Rather than a linear trajectory, involvement in this MDA trial was subjected to multiple revaluations from enrolment and consent to medicine intake and adherence to treatment. CONCLUSIONS: This study went beyond the individual factors often associated with coverage and adherence, and found that nuanced social dynamics greatly influence the decision-making process at all phases of the trial. These issues need to be consider for MDA implementation strategies and inform discussions about more accurate ways of reporting on critical effectiveness indicators.

Doing 'reciprocity work': The role of fieldworkers in a mass drug administration trial in the Gambia.

In their roles as nurses, data collectors, or other, fieldworkers undertake myriad tasks working intimately with and on the bodies of others - a type of work called 'body work'. This work further includes the micro-political relations shaping these interactions, and studies have shown the importance of these relationships in the success of clinical trials, particularly in the Gambia. This study seeks to expand the concept of body work to understand the roles and interactions of fieldworkers within the trial community, and the effect on a mass drug administration (MDA) clinical trial. We conducted a mixed-methods social science study alongside the MDA in 2018-2019, including in-depth interviews, focus group discussions, and semi-structured observations with the population involved (and not) in the MDA, as well as the MRC fieldworkers. We found that fieldworkers participated in what we call 'reciprocity work'. Through their regular tasks and interactions, they necessarily showed respect and established trust in a way that formed and contributed to reciprocal relationships, the results of which impacted the trial and individuals' autonomy in the decision-making process. Understanding the role of fieldworkers and their reciprocity work is a vital component in comprehending how research ethics are made and conducted in global health research.

The role of social cohesion in the implementation and coverage of a mass drug administration trial for malaria control in the Gambia: An in-depth comparison of two intervention villages.

Mass drug administration (MDA), used increasingly in malaria eradication efforts, involves administering medication to an entire target population regardless of individual-level disease status. This strategy requires high levels of coverage and compliance. Previous studies have assessed individual and structural factors affecting MDA coverage, but there is a need to better understand the influence and expressions of community dynamics and social structures, such as social cohesion. We conducted a social science study concurrent to an MDA clinical trial for malaria control in The Gambia; ethnographic research was conducted prior to, throughout, and between MDA implementation July-November 2018, January-March 2019, and July-November 2019. We assessed how social cohesion, as expressed by the trial population, affects trial coverage through an in-depth ethnographic analysis of two trial villages, using observations, interviews, and focus group discussions with community members who took the trial medication and those who did not. We found that the villages had unique expressions of social cohesion. This was reflected through community participation in the trial implementation and may have affected coverage and compliance. The village with low coverage expressed a form of social cohesion where members followed advice to participate through a hierarchal system but did not actively participate in the MDA or its implementation. The village with high coverage expressed social cohesion as more participatory: individuals took the directive to participate but contextualized the trial implementation to their needs and wants. We analyze these different expressions of social cohesion and the important differences they make for the coverage and compliance levels reached in the two different villages.