Fear and rumours regarding placental biopsies in a malaria-in-pregnancy trial in Benin

Abstract

BackgroundA multi-country, community-based trial on scheduled screening and treatment for malaria in pregnancy was conducted in Benin, The Gambia and Burkina Faso. Despite standardized procedures and outcomes, the study became subject to rumours and accusations of placenta being sold for mystical and financial gain by trial staff, leading to drop-out rates of 30% and the consequent halting of placental biopsy sampling in Benin. This paper explores the role of socio-cultural beliefs related to placenta and identified additional factors contributing these rumours.MethodsA qualitative comparative emergent-theory design was used to assess social factors related to trial implementation and uptake in the three countries. Data from participant observation, informal conversations, group discussions and interviews were triangulated and analysed with NVivo Qualitative Analysis software.ResultsDespite similar sociocultural beliefs about the sacred nature of the placenta in all three study countries, these beliefs did not affect participation rates in Burkina Faso and The Gambia and placenta-related rumours only emerged in Benin. Therefore, the presence of beliefs is not a sufficient condition to have generated placenta-selling fears. The rumours in Benin reflected the confluence of placenta-related beliefs and factors related to the implementation of the trial (including a catalysing adverse event and miscommunication during the informed consent procedure). Furthermore, distinct socio-political factors contributed to the emergence of rumours, including the historical distrust in governmental organizations and the tense relationship between some of the actors involved in the trial.ConclusionTransdisciplinary social science research designs should accompany the implementation of the trial. The integration of multiple stakeholders’ knowledge and involvement is required to define and solve upcoming barriers.

Perfil de investigaciones en malaria asociada al embarazo: revisión sistemática 1925-2018

“…Pese a lo anterior, no se pueden desconocer algunos cambios que, aunque incipientes, son importantes de señalar, como la incursión de las ciencias sociales, mediante estudios cualitativos, en la mae. Por ejemplo, el estudio del grupo de Arnaldo explora problemas de acceso al tratamiento preventivo, mediante entrevistas a 46 gestantes y 4 trabajadores de la salud en Mozambique, indicando una baja percepción de los riesgos y las consecuencias de la mae, y problemas de comunicación con trabajadores de la salud [38]; Compaoré et al evaluaron los factores sociales relacionados con la implementación y la aceptación de ensayos clínicos en tres países africanos [39], mientras que el grupo de Tarr-Attia exploró las percepciones de las poblaciones sobre la etiología, la prevención y el tratamiento de la mae, así como las percepciones de la comunidad y los trabajadores de la salud sobre la utilidad de la investigación en este tema, por medio de entrevistas en profundidad y grupos focales con gestantes, representantes de la comunidad y personal del hospital, haciendo uso de la teoría fundamentada y del feminismo [40].…”

Examining study participants’ decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi

“…This is consistent with previous studies conducted in low- and middle-income country settings that indicate underlying negative trial experiences are commonplace, with historic and socio-economic factors contributing to concerns [ 23 , 44 , 45 ]. In this study, the issue of “blood stealing and selling” was ever present, highlighting how widespread misconceptions about blood are in some contexts in Africa [ 22 , 24 , 46 , 47 ].…”

“…For example, participants may be advised to only eat food provided by the researchers [ 21 ], and not share designated food with others. However, challenges faced by participants in dietary intervention trials have been reported and these include safety concerns of the interventions, complexity of trial designs, lack of support from family and friends [ 17 , 18 ], lack of knowledge coupled with rumours and misconceptions about research studies [ 22 – 24 ]. These issues can affect willingness to initially participate or remain within trials and can represent a significant burden for participants, which needs to be identified and managed for the benefit of participants’ wellbeing.…”

Caregiver and community perceptions and experiences participating in an infant malaria prevention trial of PfSPZ Vaccine administered by direct venous inoculation: a qualitative study in Siaya County, western Kenya

“…The blood draws emerged as a dominant barrier to trial participation and was the most frequently cited reason for pre-vaccination consent withdrawal. Objections to the blood draw stemmed almost exclusively from fathers and mothers-in-law, were founded in concerns surrounding infant safety, and were influenced by rumours circulating in the study communities surrounding malicious ulterior motives by study staff (e.g., selling children's blood for money)-factors consistent with community objections to vaccines and experimental commodities documented in other trial/implementation settings [35][36][37][38][39][40][41]. Sustained parental and community anxieties around the blood draws reinforced skepticism and resulted in early participant termination.…”