Malaria Surveillance and Research Studies in Liberia and Guinea-Conakry

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In FY 2018, LMIV began developing two similar protocols for a cross-sectional survey of malaria and helminth prevalence in pregnant women and children at two health care facilities in Liberia (Protocol # 19-I-N007) and one health care facility in Guinea-Conakry (Protocol # 19-I-N141). The primary objective of the studies is to estimate the burden of P. falciparum in these at-risk populations. The secondary objectives are to estimate the frequency of infections due to non-falciparum malaria and to helminths (such as Strongyloides stercoralis, filarial infections, or Schistosoma) in these cohorts. To accomplish these objectives, participants are asked to provide one finger stick or heel prick blood sample which will be used to perform research assays such as rapid diagnostic tests, blood smears, malaria qPCR, and/or helminth-specific antibody responses using dried blood spots. The projects gained approvals from the NIH IRB (both protocols), the Liberian National Research Ethics Board (Protocol # 19-I-N007) and the Guinea National Ethics Committee for Research in Health / Comit National dEthique pour la Recherche en Sant (Protocol # 19-I-N141). In FY2019, Protocol # 19-I-N007 achieved the key milestones of obtaining all necessary regulatory approvals from both the Liberian National Research Ethics Board and the NIAID IRB. The protocol is currently undergoing annual continuing review with the NIH IRB. In addition, a Site Initiation Visit was conducted by the study monitors and study staff was thoroughly trained. Enrollments began in FY 2020 (October 2019 and November 2019 for C.H. Rennie and Duport Road, respectively). Enrollments paused in March 2020 due to the COVID-19 outbreak, and resumed successfully at both sites in August 2020. In FY 2019, Protocol # 19-I-N141 achieved the key milestones of obtaining all necessary regulatory approvals from both the Guinea National Ethics Committee for Research in Health and the NIH IRB. The protocol is currently undergoing annual continuing review with the NIH IRB. In FY 2020, a Site Initiation Visit was conducted by the study monitors and study staff was thoroughly trained. Enrollments began in July 2020. As of 26 August 2020, a total of 794 persons have enrolled in the two sites in Liberia, with 741 being pregnant women and 53 infants. The C.H. Rennie site has enrolled 386 pregnant women and 38 infants, while the Duport Road site has enrolled 354 pregnant women and 15 infants. The single site in Guinea has enrolled 100 participants to date, 74 pregnant women and 24 infants.