Search

Background: Chronic infection with Schistosoma haematobium causes female genital schistosomiasis (FGS), which leads to diverse lesions in the female genital tract and several complications, including infertility and a higher risk for HIV transmission. This study aims to understand the knowledge, attitudes, and practices (KAP) toward FGS and associated factors among women and health professionals in the schistosomiasis endemic focus of Kimpese, western Democratic Republic of Congo (DRC). Methods: In January 2022, two semi-quantitative questionnaires were administered to 201 randomly selected community women in Kifua II village, and to purposely selected health professionals (20 nurses and 41 doctors) from Kimpese Health Zone. KAP statements were coded using Likert scale, summarized as frequencies and percentages, and assessed for internal reliability using Cronbach's alpha. Associations between the socio-demographic characteristics of respondents and the KAP variables were assessed using Pearson chi-square (χ2) test, Cramer's V (φ) and gamma (γ) coefficients. Results: Overall, respondents had high knowledge of schistosomiasis in general but low FGS-specific knowledge (91% versus 45%). Misconceptions concerned the disease transmission, with 30.3% of women and 25% of the nurses believing that FGS is transmitted by drinking untreated water, while 26.8% of the doctors mentioned sexual contact as a mode of FGS transmission. Negative attitudes included considering FGS not a very serious disease (34.8%), feeling uncomfortable during gynaecological examination (35.3%), difficulties avoiding risky water contact (72.1%) and open defecation/urination (41.3%), not intending to share FGS status with their husbands (38.3%) and loved ones (63.6%), and believing that husbands would leave them if they were infertile (31.8%). Regarding practices, 77.6% of women engaged daily in activities involving contact with water. Practices of health professionals were hampered by the lack of equipment and specialized knowledge for FGS diagnosis with only 57% of healthcare workers having a microscope in their facilities. Women's KAPs varied by age, education, marital status, occupation and monthly income. Conclusion: This study highlights insufficient knowledge, existing negative attitudes, at risk practices towards FGS by women, and limitations of FGS management by health professionals. These findings can help for tailored health education and WASH strategies, and call for health professional's capacities reinforcement. Author summary: Schistosomiasis is a disease caused by parasitic worms and it is contracted through contact with contaminated water. FGS is a long-term consequence of urogenital schistosomiasis, a form of the disease that affects the female reproductive organs and can lead to infertility, but also stigma and discrimination. This study used a quantitative research approach to explore community women and healthcare workers' knowledge, attitudes and practices on and health-seeking behaviour of the women regarding FGS in Kongo Central, DRC. While both groups had high knowledge of schistosomiasis, they had a limited understanding of FGS specifically. Misconceptions about its cause and prevention were common, particularly among medical doctors. Many community members engaged in risky water contact and hygiene practices. Healthcare workers reported limited diagnostic tools and expressed interest in specialised training on FGS diagnosis, treatment, and prevention. Consequent to limited knowledge and ill-equipped laboratories, health workers are most likely underreporting the disease in the region. The study highlights the need to integrate FGS into public health education programs for both community members and healthcare workers in Kongo Central and underscores the importance of addressing misconceptions about the disease and the prevention measures. [ABSTRACT FROM AUTHOR]

Background In response to recent Ebola epidemics, vaccine development against the Zaire ebolavirus (EBOV) has been fast-tracked in the past decade. Health care providers and frontliners working in Ebola-endemic areas are at high risk of contracting and spreading the virus. Methods This study assessed the safety and immunogenicity of the 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo vaccine regimen (administered at a 56-day interval) among 699 health care providers and frontliners taking part in a phase 2, monocentric, randomized vaccine trial in Boende, the Democratic Republic of Congo. The first participant was enrolled and vaccinated on 18 December 2019. Serious adverse events were collected up to 6 months after the last received dose. The EBOV glycoprotein FANG ELISA (Filovirus Animal Nonclinical Group enzyme-linked immunosorbent assay) was used to measure the immunoglobulin G–binding antibody response to the EBOV glycoprotein. Results The vaccine regimen was well tolerated with no vaccine-related serious adverse events reported. Twenty-one days after the second dose, an EBOV glycoprotein–specific binding antibody response was observed in 95.2% of participants. Conclusions The 2-dose vaccine regimen was well tolerated and led to a high antibody response among fully vaccinated health care providers and frontliners in Boende. [ABSTRACT FROM AUTHOR]

In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resourceconstrained settings can raise context-related challenges that have implications for study participants' health and wellbeing. During the Ebola vaccine study, three participants were injured in road traffic accidents, but there were unexpected difficulties when trying to apply the AC policy. First, because of the nature of the adverse events, the insurer refused to cover the costs. Second, the AC policy did not address treatments by traditional medicine, even though traditional medicines are frequently used and highly trusted in the study community. This highlighted a contrast between the researchers' well-intentioned AC approach and the participants' legitimate preferences. The way in which researchers should address their responsibility to provide AC is not straightforward; it requires contextualization. Our experience highlights the importance of involving community representatives and the local ethics committee to ensure development of an AC policy that is culturally and ethically appropriate. Additionally, the insurance contract should clearly stipulate which adverse events are linked to the trial participation, and thus eligible for coverage, to avoid controversies when claims are made. [ABSTRACT FROM AUTHOR]

Introduction: A serosurvey among health care providers (HCPs) and frontliners of an area previously affected by Ebola virus disease (EVD) in the Democratic Republic of the Congo (DRC) was conducted to assess the seroreactivity to Ebola virus antigens. Methods: Serum samples were collected in a cohort of HCPs and frontliners (n = 698) participants in the EBL2007 vaccine trial (December 2019 to October 2022). Specimens seroreactive for EBOV were confirmed using either the Filovirus Animal Nonclinical Group (FANG) ELISA or a Luminex multiplex assay. Results: The seroreactivity to at least two EBOV-Mayinga (m) antigens was found in 10 (1.4%: 95% CI, 0.7–2.6) samples for GP-EBOV-m + VP40-EBOV-m, and 2 (0.3%: 95% CI, 0.0–1.0) samples for VP40-EBOV-m + NP-EBOV-m using the Luminex assay. Seroreactivity to GP-EBOV-Kikwit (k) was observed in 59 (8.5%: 95%CI, 6.5–10.9) samples using FANG ELISA. Conclusion: In contrast to previous serosurveys, a low seroprevalence was found in the HCP and frontline population participating in the EBL2007 Ebola vaccine trial in Boende, DRC. This underscores the high need for standardized antibody assays and cutoffs in EBOV serosurveys to avoid the broad range of reported EBOV seroprevalence rates in EBOV endemic areas. [ABSTRACT FROM AUTHOR]

Objective: To determine the seroprevalence of toxoplasmosis in pregnant women, as well as the proportion of acutely infected and risk factors in the Democratic Republic of Congo. Methods: Thirty maternities in Kinshasa were randomly selected and women attending antenatal consultation were invited to participate. They were interviewed with a structured questionnaire about known risk factors (age, meat consumption, contact with soil, and presence of cat) and a venous blood sample was taken. Sera were analysed for total immunoglobulins (Ig) by VIDAS Toxo Competition using Enzyme Linked Fluorescent Assay. IgM was determined by VIDIA Toxo IgM and IgG avidity by VIDAS Toxo IgG avidity. Results: A total of 781 women were included. Median age was 28 years old (IQR: 8.5). And 627 women (80.3%; 95% CI: 77.5–83.1) were found to be positive to total Ig and 17 out of 387 (4.4%; 95% CI: 2.3–6.4) were positive to IgM. IgG avidity was low for 2 (11.8%) women, intermediate for 2 (11.8%) and high for 13 women (76.4%). There was no statistically significant association between Toxoplasma gondii infection and any risk factors assessed. Conclusion: In Kinshasa, toxoplasmosis endemicity is highly prevalent. One woman out of twenty five had a recent toxoplasmosis infection and 20% were not protected against primo-infection, indicating a need for measures to prevent and control toxoplasmosis during pregnancy.

Abstract Background Despite some problems related to accuracy and applicability, malaria rapid diagnostic tests (RDTs), are currently considered the best option in areas with limited laboratory services for improving case management and reducing over-treatment. However, their performance must be established taking into the account the particularities of each endemic area. In the Democratic Republic of Congo, the validity of Optimal-IT® and Paracheck-Pf®, respectively based on the detection of lactate dehydrogenase and histidine-rich protein-2, was assessed at primary health care level (PHC). Methods This was a two-stage cluster randomized survey, conducted in one health centre in 12 health zones in Kinshasa city. All patients with malaria presumptive diagnosis were eligible. Gold standard was microscopy performed by experts from the parasitology unit, Kinshasa University. Results 624 patients were enrolled. 53.4% (95% CI: 49.4-57.3) owed a bed net, obtained in 74.5% of cases (95% CI: 69.4-79.1) through community-based distribution by the National Malaria Control Programme. Microscopy expert reading confirmed 123 malaria cases (19.7%; 95% CI: 16.7-23.1). Overall sensitivity were 79.7% (95% CI: 72.4-86.8), 87.8% (95% CI: 81.9-93.6) and 86.2% (95% CI: 79.9-92.3), respectively, for Optimal-IT®, Paracheck-Pf® and microscopy performed at PHC. Specificity was 97.0% (95% CI: 95.5-98.5), 91.6% (95% CI: 89.1-94.0) and 49.1% (95% CI: 44.7-53.4). The proportion of confirmed cases seemed similar in under-fives compared to others. Any treatment prior to the current visit was a predictor for malaria (AOR: 2.3; 95% CI: 1.5-3.5), but not malaria treatment (AOR: 0.87; 95% CI: 0.4-1.8). Bed net ownership tended to protect against malaria (AOR: 0.67; 95% CI: 0.45-0.99). Conclusion Although microscopy is considered as the "gold standard" for malaria diagnosis at point of care level, this study showed that its accuracy may not always be satisfactory when performed in health centres.

Background: Intermittent preventive treatment (IPT) is a proven malaria control strategy in infants and pregnancy. School-aged children represent 26 % of the African population, and an increasing percentage of them are scholarized. Malaria is causing 50% of deaths in this age group and malaria control efforts may shift the malaria burden to older age groups. Schools have been suggested as a platform for health interventions delivery (deworming, iron-folic acid, nutrients supplementation, (boost-)immunization) and as a possible delivery system for IPT in schoolchildren (IPTsc). However, the current evidence on the efficacy and safety of IPTsc is limited and the optimal therapeutic regimen remains controversial. Methods: A systematic search for studies reporting efficacy and safety of IPT in schoolchildren was conducted using PubMed, Web of Science, Clinicaltrials and WHO/ICTRP database, and abstracts from congresses with the following key words: intermittent, preventive treatment AND malaria OR Plasmodium falciparum AND schoolchildren NOT infant NOT pregnancy. Results: Five studies were identified. Most IPTsc regimes demonstrated substantial protection against malaria parasi-taemia, with dihydroartemisinin-piperaquine (DP) given monthly having the highest protective effect (PE) (94 %; 95 % Cl 93-96). Contrarily, SP did not provide any PE against parasitaemia. However, no IPT regimen provided a PE above 50 % in regard to anaemia, and highest protection was provided by SP+ amodiaquine (AQ) given four-monthly (50 %; 95 % Cl 41-53). The best protection against clinical malaria was observed in children monthly treated with DP (97 %; 95 % Cl 87-98). However, there was no protection when the drug was given three-monthly. No severe adverse events were associated with the drugs used for IPTsc. Conclusion: IPTsc may reduce the malaria-related burden in schoolchildren. However, more studies assessing efficacy of IPT in particular against malaria-related anaemia and clinical malaria in schoolchildren must be conducted. [ABSTRACT FROM AUTHOR]

Background: Molecular methods have great potential for sensitive parasite detection in the diagnosis of human African trypanosomiasis (HAT), but the requirements in terms of laboratory infrastructure limit their use to reference centres. A recently developed assay detects the Trypanozoon repetitive insertion mobile element (RIME) DNA under isothermal amplification conditions and has been transformed into a ready-to-use kit format, the Loopamp Trypanosoma brucei. In this study, we have evaluated the diagnostic performance of the Loopamp Trypanosoma brucei assay (hereafter called LAMP) in confirmed T.b. gambiense HAT patients, HAT suspects and healthy endemic controls from the Democratic Republic of the Congo (DRC). Methodology/Principal findings: 142 T.b. gambiense HAT patients, 111 healthy endemic controls and 97 HAT suspects with unconfirmed status were included in this retrospective evaluation. Reference standard tests were parasite detection in blood, lymph or cerebrospinal fluid. Archived DNA from blood of all study participants was analysed in duplicate with LAMP. Sensitivity of LAMP in parasitologically confirmed cases was 87.3% (95% CI 80.9–91.8%) in the first run and 93.0% (95% CI 87.5–96.1%) in the second run. Specificity in healthy controls was 92.8% (95% CI 86.4–96.3%) in the first run and 96.4% (95% CI 91.1–98.6%) in the second run. Reproducibility was excellent with a kappa value of 0.81. Conclusions/Significance: In this laboratory-based study, the Loopamp Trypanosoma brucei Detection Kit showed good diagnostic accuracy and excellent reproducibility. Further studies are needed to assess the feasibility of its routine use for diagnosis of HAT under field conditions. Author Summary: Diagnosis and effective treatment are cornerstones in the control of human African trypanosomiasis (HAT). Molecular tools such as the polymerase chain reaction (PCR) detect the parasite's DNA and are generally very sensitive and specific. However, PCR is not applicable in field settings because it requires a laboratory infrastructure and sophisticated equipment. A recently developed loop-mediated isothermal amplification (LAMP) has emerged as a simpler alternative to conventional molecular methods for the diagnosis of HAT. The test has been transformed into a diagnostic kit for qualitative detection of the parasite's DNA in clinical specimens, the Loopamp Trypanosoma brucei Detection Kit. In this study, we evaluated this kit in laboratory conditions on DNA extracted from blood samples of 142 patients, 97 suspects and 111 healthy endemic controls in the Democratic Republic of the Congo. The test showed good diagnostic accuracy and excellent reproducibility. Given the practical advantages of LAMP over conventional nucleic acid methods these are promising results. Further studies are needed to assess the test's accuracy and feasibility in field conditions. [ABSTRACT FROM AUTHOR]

Background: Molecular methods have great potential for sensitive parasite detection in the diagnosis of human African trypanosomiasis (HAT), but the requirements in terms of laboratory infrastructure limit their use to reference centres. A recently developed assay detects the Trypanozoon repetitive insertion mobile element (RIME) DNA under isothermal amplification conditions and has been transformed into a ready-to-use kit format, the Loopamp Trypanosoma brucei. In this study, we have evaluated the diagnostic performance of the Loopamp Trypanosoma brucei assay (hereafter called LAMP) in confirmed T.b. gambiense HAT patients, HAT suspects and healthy endemic controls from the Democratic Republic of the Congo (DRC). Methodology/Principal findings: 142 T.b. gambiense HAT patients, 111 healthy endemic controls and 97 HAT suspects with unconfirmed status were included in this retrospective evaluation. Reference standard tests were parasite detection in blood, lymph or cerebrospinal fluid. Archived DNA from blood of all study participants was analysed in duplicate with LAMP. Sensitivity of LAMP in parasitologically confirmed cases was 87.3% (95% CI 80.9–91.8%) in the first run and 93.0% (95% CI 87.5–96.1%) in the second run. Specificity in healthy controls was 92.8% (95% CI 86.4–96.3%) in the first run and 96.4% (95% CI 91.1–98.6%) in the second run. Reproducibility was excellent with a kappa value of 0.81. Conclusions/Significance: In this laboratory-based study, the Loopamp Trypanosoma brucei Detection Kit showed good diagnostic accuracy and excellent reproducibility. Further studies are needed to assess the feasibility of its routine use for diagnosis of HAT under field conditions. [ABSTRACT FROM AUTHOR]

While the incidence of Human African Trypanosomiasis (HAT) is decreasing, the control approach is shifting from active population screening by mobile teams to passive case detection in primary care centers. We conducted a systematic review of the literature between 1970 and 2011 to assess which diagnostic tools are most suitable for use in first-line health facilities in endemic countries. Our search retrieved 16 different screening and confirmation tests for HAT. The thermostable format of the Card Agglutination Test for Trypanosomiasis (CATT test) was the most appropriate screening test. Lateral flow antibody detection tests could become alternative screening tests in the near future. Confirmation of HAT diagnosis still depends on visualizing the parasite in direct microscopy. All other currently available confirmation tests are either technically too demanding and/or lack sensitivity and thus rather inappropriate for use at health center level. Novel applications of molecular tests may have potential for use at district hospital level. Author Summary: We conducted a systematic review of the English and French language literature indexed in PubMed between January 1970 and December 2011. Our objective was to identify which diagnostic tests are most suitable for diagnosis of Human African Trypanosomiasis (HAT) in first line health services in endemic countries. Tests were rated according to the "ASSURED" criteria, which put emphasis not only on diagnostic accuracy but also on user-friendliness and feasibility under field conditions. Diagnosis of HAT is a two-stage process in which a screening test is followed by a diagnostic confirmation test. Our search retrieved 16 different screening and diagnostic confirmation methods. The thermostable format of the CATT test came out as the most suitable screening test at health center level. It might be replaced by a lateral flow test that is currently being validated. Diagnostic confirmation tests currently available are cumbersome, technically demanding and have inadequate sensitivity; they rely on visualizing the parasite by microscopy. Without specific training and supervision, none of these tests can readily be used at health center level. Novel applications of molecular tests have the potential to replace the current diagnostic confirmation tests at district hospital level but they first need to be validated. [ABSTRACT FROM AUTHOR]

Background: Control of human African trypanosomiasis (sleeping sickness) in the Democratic Republic of Congo is based on mass population active screening by mobile teams. Although generally considered a successful strategy, the community participation rates in these screening activities and ensuing treatment remain low in the Kasai-Oriental province. A better understanding of the reasons behind this observation is necessary to improve regional control activities. Methods: Thirteen focus group discussions were held in five health zones of the Kasai-Oriental province to gain insights in the regional perceptions regarding sleeping sickness and the national control programme's activities. Principal Findings: Sleeping sickness is well known among the population and is considered a serious and life-threatening disease. The disease is acknowledged to have severe implications for the individual (e.g., persistence of manic periods and trembling hands, even after treatment), at the family level (e.g., income loss, conflicts, separations) and for communities (e.g., disruption of community life and activities). Several important barriers to screening and treatment were identified. Fear of drug toxicity, lack of confidentiality during screening procedures, financial barriers and a lack of communication between the mobile teams and local communities were described. Additionally, a number of regionally accepted prohibitions related to sleeping sickness treatment were described that were found to be a strong impediment to disease screening and treatment. These prohibitions, which do not seem to have a rational basis, have far-reaching socio-economic repercussions and severely restrict the participation in day-to-day life. Conclusions/Significance: A mobile screening calendar more adapted to the local conditions with more respect for privacy, the use of less toxic drugs, and a better understanding of the origin as well as better communication about the prohibitions related to treatment would facilitate higher participation rates among the Kasai-Oriental population in sleeping sickness screening and treatment activities organized by the national HAT control programme. Author Summary: Active screening strategies are common disease control interventions in the context of poor and remote rural communities with no direct access to healthcare facilities. For such activities to be as effective as possible, it is necessary that they are well adapted to local socio-economic and cultural settings. Our aim was to gain insight into the barriers communities in the Kasai-Oriental province of the Democratic Republic of Congo experience in relation to their participation in active screening activities for African sleeping sickness. Participation rates seem to be especially low in this province compared to other endemic regions in the country. We found several important factors to be in play, a number of which could be addressed by adapting the operational procedures of the mobile teams that perform the active screening activities (e.g., improved confidentiality during the screening procedure). However, more profound considerations were found in the form of regional beliefs related to the treatment of the disease. Although not based on rational grounds, these prohibitions seem to pose a significant barrier in a person's decision to seek diagnosis and treatment. A better understanding of these prohibitions and their origin could lead to improved participation rates for sleeping sickness screening in Kasai-Oriental. [ABSTRACT FROM AUTHOR]

Background: Despite some problems related to accuracy and applicability, malaria rapid diagnostic tests (RDTs), are currently considered the best option in areas with limited laboratory services for improving case management and reducing over-treatment. However, their performance must be established taking into the account the particularities of each endemic area. In the Democratic Republic of Congo, the validity of Optimal-ITW and Paracheck-Pf®, respectively based on the detection of lactate dehydrogenase and histidine-rich protein-2, was assessed at primary health care level (PHC). Methods: This was a two-stage cluster randomized survey, conducted in one health centre in 12 health zones in Kinshasa city. All patients with malaria presumptive diagnosis were eligible. Gold standard was microscopy performed by experts from the parasitology unit, Kinshasa University. Results: 624 patients were enrolled. 53.4% (95% CI: 49.4-57.3) owed a bed net, obtained in 74.5% of cases (95% CI: 69.4-79.1) through community-based distribution by the National Malaria Control Programme. Microscopy expert reading confirmed 123 malaria cases (19.7%; 95% CI: 16.7-23.1). Overall sensitivity were 79.7% (95% CI: 72.4-86.8), 87.8% (95% CI: 81.9-93.6) and 86.2% (95% CI: 79.9-92.3), respectively, for Optimal-IT®, Paracheck-Pf®and microscopy performed at PHC. Specificity was 97.0% (95% CI: 95.5-98.5), 91.6% (95% CI: 89.1-94.0) and 49.1% (95% CI: 44.7-53.4). The proportion of confirmed cases seemed similar in under-fives compared to others. Any treatment prior to the current visit was a predictor for malaria (AOR: 2.3; 95% CI: 1.5-3.5), but not malaria treatment (AOR: 0.87; 95% CI: 0.4- 1.8). Bed net ownership tended to protect against malaria (AOR: 0.67; 95% CI: 0.45-0.99). Conclusion: Although microscopy is considered as the "gold standard" for malaria diagnosis at point of care level, this study showed that its accuracy may not always be satisfactory when performed in health centres. [ABSTRACT FROM AUTHOR]

Background: A partnership between the University of Antwerp and the University of Kinshasa implemented the EBOVAC3 clinical trial with an Ebola vaccine regimen administered to health care provider participants in Tshuapa Province, Democratic Republic of the Congo. This randomized controlled trial was part of an Ebola outbreak preparedness initiative financed through Innovative Medicines Initiative-European Union. The EBOVAC3 clinical trial used iris scan technology to identify all health care provider participants enrolled in the vaccine trial, to ensure that the right participant received the right vaccine at the right visit.Objective: We aimed to assess the acceptability, accuracy, and feasibility of iris scan technology as an identification method within a population of health care provider participants in a vaccine trial in a remote setting.Methods: We used a mixed methods study. The acceptability was assessed prior to the trial through 12 focus group discussions (FGDs) and was assessed at enrollment. Feasibility and accuracy research was conducted using a longitudinal trial study design, where iris scanning was compared with the unique study ID card to identify health care provider participants at enrollment and at their follow-up visits.Results: During the FGDs, health care provider participants were mainly concerned about the iris scan technology causing physical problems to their eyes or exposing them to spiritual problems through sorcery. However, 99% (85/86; 95% CI 97.1-100.0) of health care provider participants in the FGDs agreed to be identified by the iris scan. Also, at enrollment, 99.0% (692/699; 95% CI 98.2-99.7) of health care provider participants accepted to be identified by iris scan. Iris scan technology correctly identified 93.1% (636/683; 95% CI 91.2-95.0) of the participants returning for scheduled follow-up visits. The iris scanning operation lasted 2 minutes or less for 96.0% (656/683; 95% CI 94.6-97.5), and 1 attempt was enough to identify the majority of study participants (475/683, 69.5%; 95% CI 66.1-73.0).Conclusions: Iris scans are highly acceptable as an identification tool in a clinical trial for health care provider participants in a remote setting. Its operationalization during the trial demonstrated a high level of accuracy that can reliably identify individuals. Iris scanning is found to be feasible in clinical trials but requires a trained operator to reduce the duration and the number of attempts to identify a participant.Trial Registration: ClinicalTrials.gov NCT04186000; https://clinicaltrials.gov/ct2/show/NCT04186000. [ABSTRACT FROM AUTHOR]

• Clinical trial regulations are becoming increasingly complex and demanding for low- and middle-income countries (LMICs) • International collaboration based on equal partnership can help LMICs perform high quality vaccine trials. • Maintaining acquired capacity while conducting clinical trials in LMICs is key and needs long term international support. • Transparency of lessons learned during clinical trials can assist for a more efficient conduct of trials. • This article describes the challenges, mitigations and lessons learned during the setup of a vaccine trial in a LMIC. Since the largest Ebola outbreak in West Africa (2013–2016) highlighted the potential threat of the Ebola virus to the world, several vaccines have been under development by different pharmaceutical companies. To obtain vaccine licensure, vaccine trials assessing the safety, immunogenicity and efficacy of new vaccines among different populations (e.g. different in age, gender, race, and ethnicity) play a crucial role. However, while this deadly disease mainly affects Central and West Africa, clinical trial regulations are becoming increasingly complex and consequently more expensive, influencing the affected low- and middle-income countries (LMICs) in performing high quality clinical trials. Consequently, the completion of such trials in LMICs takes more time and vaccines and drugs take longer to be licensed. To overcome some of the obstacles faced, the EBOVAC3 consortium, funded by the European Union's Innovative Medicines Initiative and the Coalition for Epidemic Preparedness Innovations, enabled high quality vaccine trials in Central and West Africa through extensive North-South collaborations. In this article, the encountered challenges, mitigations, recommendations and lessons learned from setting-up an Ebola vaccine trial in a remote area of the Democratic Republic of Congo are presented. These challenges are grouped into eight categories: (1) Regulatory, political and ethical, (2) Trial documents, (3) International collaborations, (4) Local trial staff, (5) Community engagement and sensitization, (6) Logistics, (7) Remoteness and climate conditions, (8) Financial. By sharing the encountered challenges, implemented mitigations and lessons learned for each of these categories, we hope to prepare and inform other researchers aspiring a well-functioning clinical trial unit in similar remote settings in LMICs. ClinicalTrials.gov identifier: NCT04186000. [ABSTRACT FROM AUTHOR]

Abstract: Confirmatory diagnosis of African trypanosomiasis relies on demonstration of parasites in body fluids by bright field microscopy. The parasitaemia in infected patients and animals is usually low, and concentration methods are used to try and increase the chances of seeing parasites. Recently, fluorescence microscopes using light-emitting diodes (LED) have been developed. Since they emit strong light, their use does not require a dark room, making field application a possibility. We have combined LED fluorescence microscopy with lysis of red blood cells (RBC) to improve the sensitivity and speed of detecting trypanosomes. In studies conducted at four centers in Uganda and the Democratic Republic of the Congo, parasitaemic blood was serially diluted and the RBCs lysed using commercial buffer. Samples were then concentrated by centrifugation, and different volumes of the sediment used to make thin and thick smears. Next, these were stained with acridine orange or Giemsa, and examined using an LED microscope under fluorescence or bright light, respectively. Detection of parasites was significantly improved by RBC lysis and concentration, regardless of the staining and microscopy method used. Further improvements were made when smears were prepared using larger volumes of sediment. The best results were obtained with thin smears prepared using 20μl of sediment and stained with acridine orange. The time taken to see the first parasite was dramatically reduced when smears were examined by LED fluorescence microscopy, compared to bright light. LED fluorescence microscopy was found to be easier and requiring less visual effort than bright field microscopy. These studies demonstrate the potential for incremental improvement in detection of Trypanosoma brucei by combining LED fluorescence microscopy with RBC lysis and concentration. The lysis and concentration method may also be useful in sample preparation for other diagnostic tests for trypanosomiasis. [Copyright &y& Elsevier]

Abstract: Cysticercosis results from tissue infection with the larval stage of the pig tapeworm Taenia solium. Infection of the brain may cause neurocysticercosis, the most frequent cause of acquired epilepsy in developing countries. Information on human cysticercosis in the Democratic Republic of Congo (DRC) is scarce and outdated. We believe this is the first reported study on human cysticercosis and epilepsy in a village community of DRC. The proportion of villagers seropositive by ELISA for T. solium circulating antigen was 21.6%, the highest figure reported to date. The adjusted prevalence of active epilepsy in the community was 12.7 in 1,000. [Copyright &y& Elsevier]