Safety and Immunogenicity of the Heterologous 2-Dose Ad26.ZEBOV, MVA-BN-Filo Vaccine Regimen in Health Care Providers and Frontliners of the Democratic Republic of the Congo.

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.

Prevalence and predictors of adverse events following exposure to long-lasting insecticidal nets used for malaria prevention: a community based cross-sectional study in the Democratic Republic of the Congo.

BACKGROUND: Malaria morbidity and mortality increase in the Democratic Republic of the Congo (DRC) may be the consequence of the low utilization rate of long-lasting insecticidal nets (LLINs) resulting from poor compliance due to adverse events (AEs). This study aimed at determining the prevalence and predictors of AEs following the mass distribution of LLINs in the Kisantu Health Zone (KHZ), a high malaria-endemic region in the DRC. METHODS: A community-based cross-sectional study embedded was conducted within a randomized controlled trial (RCT) after the mass distribution of LLINs in 30 villages located in DRC KHZ. A three-stage sampling method was used without replacement to select 1790 children. Data was collected on adverse events (AEs) using a reporting form and information on demographics, nutritional status, and house characteristics. This was done using a structured questionnaire administered to household heads. Logistic regression models were used to identify predictors of AEs following the mass distribution of LLINs. RESULT: In a total of 1790 children enrolled, 17.8% (95% CI 16.1-19.7) experienced AEs. The most common AEs were respiratory-related (61%). Around 60% of AEs occurred within 24 h of use, and 51% were resolved without treatment. Sleeping under deltamethrin LLINs (Adjusted OR, 95% CI 5.5 [3.8-8.0]) and zinc roofing (Adjusted OR, 95% CI 1.98 [1.1-3.57]) were associated with the risk of reporting an AE following the mass distribution of LLINs. CONCLUSION: Approximately 1 out of 5 children had an AE within 24 h following LLIN use. These adverse events were often respiratory-related. LLINs and roofing types were associated with a higher risk of reporting AEs. However, further research using a robust study design is needed to confirm these findings. Future studies should design and implement interventions aiming to reduce AEs and improve compliance with LLINs.

Malaria among children under 10 years in 4 endemic health areas in Kisantu Health Zone: epidemiology and transmission.

BACKGROUND: The Democratic Republic of the Congo (DRC) is the second most malaria-affected country in the world with 21,608,681 cases reported in 2019. The Kongo Central (KC) Province has a malaria annual incidence of 163 cases/per 1000 inhabitants which are close to the national average of 153.4/1000. However, the malaria prevalence varies both between and within health zones in this province. The main objective of this study was to describe the epidemiology and transmission of malaria among children aged 0 to 10 years in the 4 highest endemic health areas in Kisantu Health Zone (HZ) of KC in DRC. METHODS: A community-based cross-sectional study was conducted from October to November 2017 using multi-stage sampling. A total of 30 villages in 4 health areas in Kisantu HZ were randomly selected. The prevalence of malaria was measured using a thick blood smear (TBS) and known predictors and associated outcomes were assessed. Data are described and association determinants of malaria infection were analysed. RESULTS: A total of 1790 children between 0 and 10 years were included in 30 villages in 4 health areas of Kisantu HZ. The overall prevalence in the study area according to the TBS was 14.8% (95% CI: 13.8-16.6; range: 0-53). The mean sporozoite rate in the study area was 4.3% (95% CI: 2.6-6.6). The determination of kdr-west resistance alleles showed the presence of both L1014S and L1014F with 14.6% heterozygous L1014S/L1014F, 84.4% homozygous 1014F, and 1% homozygous 1014S. The risk factors associated with malaria infection were ground or wooden floors aOR: 15.8 (95% CI: 8.6-29.2), a moderate or severe underweight: 1.5 (1.1-2.3) and to be overweight: 1.9 (95% CI: 1.3-2.7). CONCLUSION: Malaria prevalence differed between villages and health areas within the same health zone. The control strategy activities must be oriented by the variety in the prevalence and transmission of malaria in different areas. The policy against malaria regarding long-lasting insecticidal nets should be based on the evidence of metabolic resistance.

Implementation research of a cluster randomized trial evaluating the implementation and effectiveness of intermittent preventive treatment for malaria using dihydroartemisinin-piperaquine on reducing malaria burden in school-aged children in Tanzania: methodology, challenges, and mitigation.

BACKGROUND: It has been more than 20 years since the malaria epidemiologic shift to school-aged children was noted. In the meantime, school-aged children (5-15 years) have become increasingly more vulnerable with asymptomatic malaria prevalence reaching up to 70%, making them reservoirs for subsequent transmission of malaria in the endemic communities. Intermittent Preventive Treatment of malaria in schoolchildren (IPTsc) has proven to be an effective tool to shrink this reservoir. As of 3rd June 2022, the World Health Organization recommends IPTsc in moderate and high endemic areas. Even so, for decision-makers, the adoption of scientific research recommendations has been stifled by real-world implementation challenges. This study presents methodology, challenges faced, and mitigations used in the evaluation of the implementation of IPTsc using dihydroartemisinin-piperaquine (DP) in three councils (Handeni District Council (DC), Handeni Town Council (TC) and Kilindi DC) of Tanga Region, Tanzania so as to understand the operational feasibility and effectiveness of IPTsc on malaria parasitaemia and clinical malaria incidence. METHODS: The study deployed an effectiveness-implementation hybrid design to assess feasibility and effectiveness of IPTsc using DP, the interventional drug, against standard of care (control). Wards in the three study councils were the randomization unit (clusters). Each ward was randomized to implement IPTsc or not (control). In all wards in the IPTsc arm, DP was given to schoolchildren three times a year in four-month intervals. In each council, 24 randomly selected wards (12 per study arm, one school per ward) were chosen as representatives for intervention impact evaluation. Mixed design methods were used to assess the feasibility and acceptability of implementing IPTsc as part of a more comprehensive health package for schoolchildren. The study reimagined an existing school health programme for Neglected Tropical Diseases (NTD) control include IPTsc implementation. RESULTS: The study shows IPTsc can feasibly be implemented by integrating it into existing school health and education systems, paving the way for sustainable programme adoption in a cost-effective manner. CONCLUSIONS: Through this article other interested countries may realise a feasible plan for IPTsc implementation. Mitigation to any challenge can be customized based on local circumstances without jeopardising the gains expected from an IPTsc programme. Trial registration clinicaltrials.gov, NCT04245033. Registered 28 January 2020, https://clinicaltrials.gov/ct2/show/NCT04245033.

Effect of malaria prevention education on bed net utilization, incidence of malaria and treatment seeking among school-aged children in Southern Ethiopia; cluster randomized controlled trial.

BACKGROUND: School-aged children (SAC) have an increased risk to contract malaria and play a major role in its transmission dynamics. However, their malaria prevention experience is poor. Thus, the effect of malaria prevention education (MPE) on bed net utilization, treatment seeking from a health facility and cumulative incidence of malaria was evaluated in Southern Ethiopia. METHODS: A two arm cluster randomized controlled trial was conducted by recruiting 2038 SAC from 32 schools. Structured questionnaire was used to collect data on socio-demographic, economic, bed net ownership, bed net utilization, whether the participated child suffered from malaria and has got treatment from a health facility. Generalized mixed effect logistic regression using school as random variable was used to assess the effect of the intervention on the outcome variables. RESULTS: The ownership of bed net in households of the control and intervention schools was similar respectively with 84.6 and 88.6% (Crude Odds Ratio (COR): 1.5; 95%CI: 0.5-4.8). The percentage of SAC slept under the bed net the night before the survey was also similar (55.1% versus 54.0%); COR:1.04; 95%CI: 0.5-2.4). Bed net utilization was affected by household size to the bed net ratio ≤ 2 (Adjusted Odds Ratio (AOR) = 1.6; 95%CI:1.3-2.1), bed net utilization at baseline of the study (AOR = 2.3; 95%CI:1.5-3.6), and history of malaria attack in the last twelve months (AOR = 1.3; 95%CI:1.01-1.8). Reported cumulative incidence of malaria and treatment seeking from a health facility by SAC was similar between intervention and control arms: -2.1% (COR = 0.8; 95%CI: 0.5-1.5) and 9.6% (COR = 1.4; 95%CI: 0.4-4.3) respectively. The reported incidence of malaria was affected by altitude (AOR = 0.5; 95%CI: 0.3-0.8), low and medium wealth index (AOR = 0.7; 95%CI: 0.5-0.96 and AOR = 0.7; 95%CI: 0.5-0.98), adequate bed net number for household members (AOR = 0.7; 95%CI:0.5-0.9) and bed net utilization (AOR = 1.3; 95%CI:1.1-1.8). CONCLUSIONS: MPE had no significant effect on the use of malaria prevention measures considered, treatment seeking from a health facility and reported cumulative incidence of malaria though bed net use was associated with malaria incidence. Before organizing any health education program, sustainable implementation efforts have to be warranted especially in SAC, a neglected but relevant vulnerable and reservoirs. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202001837195738, registered 21/01/2020.

Determinants of maternal healthcare utilisation among pregnant women in Southern Ethiopia: a multi-level analysis.

BACKGROUND: Despite efforts to make maternal health care services available in rural Ethiopia, utilisation status remains low. Therefore, this study aimed to assess maternal health care services' status and determinants in rural Ethiopia. METHODS: The study used quasi-experimental pre- and post-comparison baseline data. A pretested, semi-structured, interviewer-administered questionnaire was used to collect data. A multilevel, mixed-effects logistic regression was used to identify individual and communal level factors associated with utilisation of antenatal care (ANC), skilled birth attendance (SBA), and postnatal care (PNC). The adjusted odds ratio (AOR) and corresponding 95% confidence intervals (CI) were estimated with a p-value of less than 0.05, indicating statistical significance. RESULTS: Seven hundred and twenty-seven pregnant women participated, with a response rate of 99.3%. Four hundred and sixty-one (63.4%) of the women visited ANC services, while 46.5% (CI: 42-50%) of births were attended by SBA, and 33.4% (CI: 30-36%) had received PNC. Women who reported that their pregnancy was planned (aOR = 3.9; 95% CI: 1.8-8.3) and were aware of pregnancy danger signs (aOR = 6.8; 95% CI: 3.8-12) had a higher likelihood of attending ANC services. Among the cluster-level factors, women who lived in lowlands (aOR = 4.1; 95% CI: 1.1-14) and had easy access to transportation (aOR = 1.9; 95% CI: 1.1-3.7) had higher odds of visiting ANC services. Moreover, women who were employed (aOR = 3.1; 95% CI: 1.3-7.3) and attended ANC (aOR = 3.3; 95% CI: 1.8-5.9) were more likely to have SBA at delivery. The likelihood of being attended by SBA during delivery was positively correlated with shorter travel distances (aOR = 2.9; 95% CI: 1.4-5.8) and ease of access to transportation (aOR = 10; 95% CI: 3.6-29) to the closest healthcare facilities. Being a midland resident (aOR = 4.7; 95% CI: 1.7-13) and having SBA during delivery (aOR = 2.1; 95% CI: 1.2-3.50) increased the likelihood of attending PNC service. CONCLUSIONS: Overall, maternal health service utilisation is low in the study area compared with the recommended standards. Women's educational status, awareness of danger signs, and pregnancy planning from individual-level factors and being a lowland resident, short travel distance to health facilities from the cluster-level factors play a crucial role in utilising maternal health care services. Working on women's empowerment, promotion of contraceptive methods to avoid unintended pregnancy, and improving access to health care services, particularly in highland areas, are recommended to improve maternal health service utilisation.

Dietary outcomes of community-based CVD preventive interventions: a systematic review and meta-analysis.

OBJECTIVE: We aimed to synthesise available evidence on the effects of community-based interventions in improving various dietary outcome measures. DESIGN: Systematic review and meta-analysis. SETTING: We searched databases including Medline, EMBASE, PSYCINFO, CINAHL and the Cochrane registry for studies reported between January 2000 and June 2022. The methodological quality of the included studies was evaluated using the Cochrane risk of bias tools for each study type. For some of the outcomes, we pooled the effect size using a random-effects meta-analysis. PARTICIPANTS: A total of fifty-one studies, thirty-three randomised and eighteen non-randomised, involving 100 746 participants were included. RESULTS: Overall, thirty-seven studies found a statistically significant difference in at least one dietary outcome measure favouring the intervention group, whereas fourteen studies found no statistically significant difference. Our meta-analyses indicated that, compared with controls, interventions were effective in decreasing daily energy intake (MJ/d) (mean difference (MD): -0·25; 95 % CI: -0·37, -0·14), fat % of energy (MD: -1·01; 95 % CI: -1·76, -0·25) and saturated fat % of energy (MD: -1·54; 95 % CI: -2·01, -1·07). Furthermore, the interventions were effective in improving fibre intake (g/d) (MD: 1·08; 95 % CI: 0·39, 1·77). Effective interventions use various strategies including tailored individual lifestyle coaching, health education, health promotion activities, community engagement activities and/or structural changes. CONCLUSION: This review shows the potential of improving dietary patterns through community-based CVD preventive interventions. Thus, development and implementation of context-specific preventive interventions could help to minimise dietary risk factors, which in turn decrease morbidity and mortality due to CVD and other non-communicable diseases.

Evaluation of a community-based intervention package to improve knowledge of obstetric danger signs, birth preparedness, and institutional delivery care utilization in Arba Minch Zuria District, Ethiopia: a cluster-randomized trial.

INTRODUCTION: Maternal healthcare utilization, particularly the institutional delivery, is disproportionately low in rural Ethiopia. This study aimed to evaluate the effectiveness of an integrated package of community-based interventions on the improved knowledge of obstetric danger signs, birth preparedness, and institutional delivery services utilization in rural areas of Gamo zone, southern Ethiopia. METHODS: We conducted cluster-randomized controlled trial (NCT05385380) from 2019 to 2021 at the Arba Minch Health and Demographic Surveillance System site. We randomly assigned the 10 kebele clusters to intervention and control arm. We used a package of interventions, which included providing information on safe motherhood via video and/or audio with a birth preparedness card for pregnant women, training for community volunteers and health extension workers, and improving maternity waiting home services. Women in the control arm received routine services only. We used generalized mixed-effects logistic regression models to evaluate the effectiveness of the intervention on the outcome variables. RESULTS: The study enrolled 727 pregnant women across the 10 clusters, with a 617 (84.9%) successful follow-up rate. The proportion of institutional delivery in the intervention arm was increased by 16.1% from 36.4% (174/478) at the baseline to 52.5% (224/427) at the endline (Adjusted odds ratio [AOR] for McNemar's Test = 1.5; 95% confidence interval [CI]: 1.1 to 2; p < 0.001). In the control arm, however, there was a 10.3% fall in the proportion of institutional delivery (from 164/249 to 105/190). Pregnant women who received the intervention were significantly more likely to give birth in a health institution than those who did not (AOR 2.8; 95% CI: 1.2, 6.4). CONCLUSION: The study demonstrates that an integrated community-based intervention package that included video-based storytelling and upgrading maternity waiting homes increased institutional delivery care utilization among rural women. We recommend that audio-visual storytelling, starting during pregnancy and continuing postpartum, be incorporated into routine maternal healthcare services to address access to care inequalities in rural settings. TRIAL REGISTRATION: The study protocol was registered in the clinicaltrials.gov with registry number NCT05385380.

Many women in developing nations, including Ethiopia, are dying due to problems related to pregnancy and childbirth. One of the interventions to prevent maternal illness and deaths is promoting and ensuring the timely use of maternal health care services. This study aimed to evaluate the effectiveness of an integrated package of community-based interventions on the improved institutional birth rate in rural Ethiopia. We conducted a trial at the Arba Minch HDSS site. The package provided information on safe motherhood via videos and audiocassettes for pregnant women, a birth preparedness card for women, community volunteers and extension workers training, and maternity waiting home services upgrading. In the control arm, women received routine services only. From the 10 Arba Minch HDSS kebele clusters, six kebele clusters were randomly assigned to the intervention and an additional four were assigned to the control. Different statistical techniques were used to evaluate the effectiveness of the intervention on the institutional birth rate. At the baseline, 727 pregnant women had enrolled across all 10 clusters, with a 617 (84.9%) successful follow-up rate. The intervention arm had a higher proportion of institutional birth (224/427 [52.5%]) at the endline than the baseline (174/478 [36.4%). Furthermore, the study showed a significant association between intervention status and institutional birth rate. Therefore, stimulating demand for existing services to ensure the timely use of care can improve maternal health service utilization, particularly the institutional birth rate.

Benefits, barriers and enablers of maternity waiting homes utilization in Ethiopia: an integrative review of national implementation experience to date.

BACKGROUND: Though Ethiopia has expanded Maternity Waiting Homes (MWHs) to reduce maternal and perinatal mortality, the utilization rate is low. To maximize the use of MWH, policymakers must be aware of the barriers and benefits of using MWH. This review aimed to describe the evidence on the barriers and benefits to access and use of MWHs in Ethiopia. METHODS: Data were sourced from PubMed, Google Scholars and Dimensions. Thirty-one studies were identified as the best evidence for inclusion in this review. We adopted an integrative review process based on the five-stage process proposed by Whittemore and Knafl. RESULTS: The key themes identified were the benefits, barriers and enablers of MWH utilization with 10 sub-themes. The themes about benefits of MWHs were lower incidence rate of perinatal death and complications, the low incidence rate of maternal complications and death, and good access to maternal health care. The themes associated with barriers to staying at MWH were distance, transportation, financial costs (higher out-of-pocket payments), the physical aspects of MWHs, cultural constraints and lack of awareness regarding MWHs, women's perceptions of the quality of care at MWHs, and poor provider interaction to women staying at MWH. Enablers to pregnant women to stay at MWHs were availability of MWHs which are attached with obstetric services with quality and compassionate care. CONCLUSION: This study synthesized research evidence on MWH implementation, aiming to identify benefits, barriers, and enablers for MWH implementation in Ethiopia. Despite the limited and variable evidence, the implementation of the MWH strategy is an appropriate strategy to improve access to skilled birth attendance in rural Ethiopia.

Age-modified factors associated with placental malaria in rural Burkina Faso.

BACKGROUND: Malaria in pregnancy can result in placental infection with fetal implications. This study aimed at assessing placental malaria (PM) prevalence and its associated factors in a cohort of pregnant women with peripheral malaria and their offspring. METHOD: The data were collected in the framework of a clinical trial on treatments for malaria in pregnant women . Placental malaria (PM) was diagnosed by histopathological detection of parasites and/or malaria pigment on placenta biopsies taken at delivery. Factors associated with PM were assessed using logistic regression. RESULTS: Out of 745 biopsies examined, PM was diagnosed in 86.8 % of women. Acute, chronic and past PM were retrieved in 11 (1.5 %), 170 (22.8 %), and 466 (62.6 %) women, respectively. A modifying effect was observed in the association of gravidity or anemia at the study start with pooled PM (presence of parasites and/or malaria pigment). In women under 30, gravidity ≤ 2 was associated with an increased prevalence of pooled PM but in women aged 30 years or more, gravidity was no more associated with pooled PM (OR 6.81, 95 % CI 3.18 - 14.60; and OR 0.52, 95 % CI 0.10 - 2.76, respectively). Anemia was associated with pooled PM in women under 30 (OR 1.96, 95 % CI 1.03 - 3.72) but not in women aged 30 years or more (OR 0.68, 95 % CI 0.31 - 1.49). Similarly, the association of gravidity with past-chronic PM depended also on age. A higher prevalence of active PM was observed in women under 30 presenting with symptomatic malaria (OR 3.79, 95 % CI 1.55 - 9.27), while there was no significant increase in the prevalence of active PM (presence of parasites only) in women with symptomatic malaria when aged 30 years or more (OR 0.42, 95 % CI 0.10 - 1.75). In women with chronic PM, the prevalence of low birth weight or prematurity was the highest (31.2 %) as compared with past PM or no PM. CONCLUSION: Despite the rapid diagnosis and efficacious treatment of peripheral infection, the prevalence of placental malaria remained high in women with P. falciparum peripheral infection in Nanoro, especially in younger women This underlines the importance of preventive measures in this specific group.

Implementation of a malaria prevention education intervention in Southern Ethiopia: a qualitative evaluation.

BACKGROUND: Though school-aged children (SAC) are at high risk of malaria, they are the ones that benefit the least from malaria prevention measures. A cluster randomized controlled trial was conducted to evaluate the effect of malaria prevention education (MPE) on insecticide-treated bed net (ITN) utilization and prompt diagnosis, reported incidence and treatment (PDAT) of malaria. Qualitative evaluation of the implementation of such interventions is vital to explain its effectiveness and will serve as guidance for future interventions. Therefore, this study aimed to evaluate the implementation of the MPE in southern Ethiopia.  METHODS: The trial was registered in Pan African Clinical Trials Registry (PACTR202001837195738) on 21/01/2020. A descriptive qualitative study using semi-structured interview with participants of the MPE was conducted in January 2020 and January 2021. The collected data were transcribed verbatim and analyzed thematically. The analysis of the data was supported by NVivo. RESULTS: The four themes identified after evaluation of MPE training were the setup of the training, challenges for the success of the training, anticipated challenges for practice as per the protocol and experienced immediate influences of the training. Participants appreciated the training: content covered, way of delivery and the mix of the participants. The context specific facilitators to bed net use were the collateral benefits of ITN and perceived at high risk of malaria while its barriers were quality and quantity of the bed nets, bed net associated discomforts, malaria health literacy and housing condition. Severeness of malaria symptoms and malaria health literacy were reported as both barriers and facilitators of the PDAT of malaria. The identified facilitators of PDAT of malaria were health professionals' attitude and exposure to MPE while its barriers were poverty, use of traditional medicine, health facility problems and Coronavirus Disease 2019 (COVID-19) pandemic. CONCLUSION: Low attendance of parents in the training was the major challenge for the success of MPE. National malaria program should ensure the access to malaria prevention measures; and future studies using increased frequency of the intervention embedded with monitoring adherence to the intervention protocol shall be conducted to improve the gains from existing malaria interventions.

Evaluating the effectiveness of enhanced family planning education on knowledge and use of family planning in fishing communities of Lake Victoria in Uganda: a randomized controlled trial.

INTRODUCTION: Family planning knowledge is poor and use is low in Ugandan fishing communities. We compared the effectiveness of enhanced family planning (FP) education with routine counselling on FP knowledge and use. METHODS: Individuals aged 15-49 years were randomly assigned to intervention or control arm. The intervention constituted enhanced FP education based on a simplified handout extracted from the WHO FP guidance tool called, "Family planning: A global handbook for FP providers" which participants took home for additional reading. The control arm constituted FP counselling following Uganda Ministry of Health guidelines. FP knowledge score and contraceptive prevalence rate (CPR) were compared between trial arms at baseline and at 12 months. Negative binomial regression models were used to estimate the effect of the intervention on FP knowledge and use. RESULTS: Overall, 1410 participants were screened to enrol 1004 (502 per study arm, 48.5% women). Subsequently, 384 (76.5%) and 383 (76.3%) completed the 12 months' follow-up in the intervention and control arms respectively. At baseline, a median FP knowledge score of 8 and a < 70% FP knowledge score was observed for all participants with a CPR of 36.8%. At month-12, the median FP knowledge score improved in both arms, higher in the intervention arm than the control arm (46 vs 30; p < 0.001). In the intervention arm, 304 (79.2%) had a score of ≥70 compared with 21 (5.5%) in the control arm (p < 0.001). In the negative binomial regression model, the change in FP knowledge score was 47% higher in the intervention arm than in the control arm (score ratio: 1.47, 95%CI: 1. 43-1.51, p < 0.001). The change in CPR was 16% higher in the intervention arm than in the control arm (Prevalence ratio: 1.16, 95%CI: 1.01-1.34, p < 0.040). INTERPRETATION: Enhanced FP education using a simplified FP education handout was more effective in increasing FP knowledge and use compared to routine FP counselling for people living in fishing communities. Innovative FP education interventions are recommended for improving FP knowledge and optimizing uptake in remote-rural settings where literacy levels are low. TRIAL REGISTRATION: The study was registered by the Pan African Clinical Trial Registry on 03 July 2021 with a Trial Registration Number PACTR202107891858045 . "Retrospectively registered".

Prevalence and associated risk factors of asymptomatic malaria and anaemia among school-aged children in Dara Mallo and Uba Debretsehay districts: results from baseline cluster randomized trial.

BACKGROUND: Despite the growing evidence that malaria and anaemia are two interlinked health problems of school-aged children (SAC) in developing countries, there is scarce information about malaria among SAC in Ethiopia. Moreover, anaemia-related studies were more concentrated in easily accessible areas. This study aimed to assess the prevalence of malaria and anaemia and corresponding risk factors among SAC in Dara Mallo and Uba Debretshay districts, in hard to reach areas, so as to inform appropriate integrated interventions for both diseases. METHODS: This study was part of baseline data collected for a cluster-randomized trial registered in Pan African Clinical Trials Registry (PACTR202001837195738). Data were collected from 2167 SAC and their households through face-to-face interview; malaria was diagnosed by using rapid diagnostic test (RDT); haemoglobin concentration was determined using hemoCue hb 301 and adjusted for altitude to determine anaemic status; helminth infections were determined by using kato-katz, and anthropometric measurements were made to determine nutritional status of children. Generalized mixed effects logistic regression model was used to assess the association between predictor variables and malaria and anaemia using school as a random variable. RESULTS: The overall prevalence of malaria was 1.62% (95% CI 1.15-2.27%) (35/2167). Of the 35 children positive for malaria, 20 (57.14%), 3 (8.57%) and 12 (34.29%) were due to Plasmodium falciparum, Plasmodium vivax and mixed infections of P. falciparum and P. vivax, respectively. Malaria was significantly lower among children from literate household head (Adjusted OR = 0.38; 95% CI 0.15-0.95) and residence house located at an altitude range above 1100 masl (AOR = 0.40; 95% CI 0.17-0.94). The prevalence of anaemia was 22.00% (95% CI 20.3-23.8%) (477/2167) and was significantly reduced by eating legumes, nuts or seed group of food in their 24-h dietary diversity recall (AOR = 0.64; 95% CI 0.41-0.99). CONCLUSIONS: The prevalence of malaria was low and unevenly distributed per school while the overall prevalence of anaemia was moderate. It is important to implement integrated interventions targeting both malaria and anaemia, with special emphasis given to children from illiterate households and living at an altitude below 1100 masl. The micronutrient content of locally grown legumes should be further investigated to recommend specific interventions to overcome anaemia.

Gametocyte carriage after seasonal malaria chemoprevention in Plasmodium falciparum infected asymptomatic children.

BACKGROUND: Treatment of clinical Plasmodium falciparum malaria with sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) is associated with increased post-treatment gametocyte carriage. The effect of seasonal malaria chemoprevention (SMC) with SP and AQ on gametocyte carriage was assessed in asymptomatic P. falciparum infected children. METHODS: The study was carried out in eastern Gambia. Asymptomatic P. falciparum malaria infected children aged 24-59 months old who were eligible to receive SMC (SMC group) and children 5-8 years that were not eligible to receive SMC (comparison group) were recruited. Gametocytaemia was determined by molecular methods before and after SMC administration. Gametocyte carriage between the groups was compared using the chi-squared test and within-person using conditional logistic regression. RESULTS: During the 2017 and 2018 malaria transmission seasons, 65 and 75 children were recruited in the SMC and comparison groups, respectively. Before SMC administration, gametocyte prevalence was 10.7% (7/65) in the SMC group and 13.3% (10/75) in the comparison group (p = 0.64). At day 13 (IQR 12, 13) after SMC administration, this was 9.4% (5/53) in children who received at least the first dose of SMC treatment and 12.7% (9/71) for those in the comparison group (p = 0.57). Similarly, there was no difference in prevalence of gametocytes between children that adhered to all 3-day doses of SMC treatment 15.6% (5/32) and those in the comparison group (p = 0.68). In the SMC group, within-group gametocyte carriage was similar before and after SMC administration in children that received at least the first dose of SMC treatment (OR 0.6, 95% CI 0.14-2.51; p = 0.48) and in those that adhered to all 3-day doses of SMC treatment (OR 1.0, 95% CI 0.20-4.95; p = 1.0). CONCLUSION: In this study with relative low gametocyte prevalence prior to SMC treatment, no evidence was observed that SMC treatment increased gametocyte carriage in asymptomatic P. falciparum malaria infected children.

Effectiveness of community-based cardiovascular disease prevention interventions to improve physical activity: A systematic review and meta-regression.

Cardiovascular diseases (CVDs) remain a leading cause of morbidity and mortality globally. Despite preventive community-based interventions (CBIs) seem efficacious in reducing CVD risks, a comprehensive up-to-date synthesis on the effectiveness of such interventions in improving physical activity (PA) is lacking. We performed a systematic review and meta-analysis of community-based CVD preventive interventions aimed at improving PA level. MEDLINE, EMBASE, CINAHL, Cochrane register and PSYCINFO databases were searched in October 2019 for studies reported between January 2000 and June 2019. We assessed the methodological quality of included studies using the Cochrane risk of bias tools. We performed a random-effects meta-analysis and meta-regression to pool estimates of various effect measures. Results are reported in line with the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guideline. Our study protocol was registered in the PROSPERO database (CRD42019119885). A total of 44 randomized and 20 non-randomized controlled studies involving 98,919 participants were included. Meta-analyses found that CBIs improved the odds of attaining the recommended PA level (at least 150 min of moderate and vigorous PA (MVPA)/week) at 12 month (OR: 1.62; 95%CI: 1.25-2.11) and 18 to 24 months of follow-up (OR: 1.46; 95%CI: 1.12-1.91). Furthermore, interventions were effective in improving metabolic equivalents of task at 12 month (standardized mean difference (SMD): 0.28; 95% CI: 0.03-0.53), MVPA time at 12 to 18 months (SMD: 0.34; 95%CI: 0.05-0.64), steps per day (SMD: 0.32; 95%CI: 0.08-0.55), and sitting time (SMD: -0.25; 95%CI: -0.34 to -0.17). Subgroup analyses found that interventions in low- and middle-income countries showed a greater positive effect on attainment of recommended PA level (OR: 1.40; 95%CI: 1.02-1.92) than those in high-income countries (OR: 1.31; 95%CI: 0.96-1.78). Moreover, interventions targeting high-risk groups showed greater effectiveness than those targeting the general population (OR: 1.76; 95%CI: 1.30-2.39 vs. 1.17; 95%CI: 0.89-1.55). In conclusion, community-based CVD preventive interventions have a positive impact on improving the PA level, albeit that relevant studies in lower-middle and low-income countries are limited. With the rising burden of CVDs, rolling out CBIs targeting the general population and high-risk groups are needed to control the growing CVD-burden.

Maternity waiting homes as component of birth preparedness and complication readiness for rural women in hard-to-reach areas in Ethiopia.

BACKGROUND: In rural areas of Ethiopia, 57% of births occur at home without the assistance of skilled birth attendants, geographical inaccessibility being one of the main factors that hinder skilled birth attendance. Establishment of maternity waiting homes (MWH) is part of a strategy to improve access to skilled care by bringing pregnant women physically close to health facilities. This study assessed barriers to MWHs in Arba Minch Zuria District, Southern Ethiopia. METHODS: A community-based cross-sectional study was undertaken from February 01 to 28, 2019. Study participants were selected by computer-generated random numbers from a list of women who gave birth from 2017 to 2018 in Arba Minch Health and Demographic Surveillance System site. Data were collected using a pre-tested and interviewer-administered questionnaire. Stata software version-15 was used for data management and analysis, and variables with p-values ≤ 0.2 in bivariate analysis were considered for multivariable logistic regression analysis. Level of statistical significance was declared at a p-value < 0.05. Qualitative data were analyzed manually based on thematic areas. RESULTS: MWH utilization was found to be 8.4%. Wealth index (lowest wealth quintile aOR 7.3; 95% CI 1.2, 42), decisions made jointly with male partners (husbands) for obstetric emergencies (aOR 3.6; 95% CI 1.0, 12), birth preparedness plan practice (aOR 6.5; 95% CI 2.3, 18.2), complications in previous childbirth (aOR 3; 95% 1.0, 9), history of previous institutional childbirth (aOR 12; 95% CI 3.8, 40), residence in areas within two hours walking distance to the nearest health facility (aOR 3.3; 95% CI: 1.4, 7.7), and ease of access to transport in obstetric emergencies (aOR 8.8; 95% CI: 3.9, 19) were factors that showed significant associations with MWH utilization. CONCLUSIONS: A low proportion of women has ever used MWHs in the study area. To increase MWH utilization, promoting birth preparedness practices, incorporating MWH as part of a personalized birth plan, improving access to health institutions for women living far away and upgrading existing MWHs are highly recommended.

Use of Iris Scanning for Biometric Recognition of Healthy Adults Participating in an Ebola Vaccine Trial in the Democratic Republic of the Congo: Mixed Methods Study.

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.

Long-lasting insecticide-treated bed net ownership, utilization and associated factors among school-age children in Dara Mallo and Uba Debretsehay districts, Southern Ethiopia.

BACKGROUND: Malaria is one of the major causes of morbidity and mortality among school-age children (SAC) in sub-Saharan Africa. SAC account for more than 60% of the reservoir of malaria transmission, but they are given less emphasis in prioritizing malaria prevention interventions. This study was aimed at assessing the ownership of long-lasting insecticide treated bed nets (LLINs), its utilization and factors associated with ownership of LLINs by households and LLINs utilization among SAC in malaria-prone areas of Dara Mallo and Uba Debretsehay districts in Southern Ethiopia, October to December 2019. METHODS: This study is part of a baseline assessment in a cluster-randomized controlled trial. The data was collected through interview and observation, following a structured questionnaire, of 2261 SAC households. Univariable and multivariable multilevel logistic regressions were used to assess the association between LLINs ownership and utilization and potential predictor variables. Odds ratio (OR) and corresponding 95% confidence interval (CI) were used to determine the strength and statistical significance of association. RESULTS: The ownership of at least one LLIN by households of SAC was about 19.3% (95% CI 17.7-21.0%) but only 10.3% % (95% CI 7.7-13.7%) of these households had adequate access of bed nets to the household members. Ownership of bed net was marginally affected by living in semi-urban area (adjusted OR = 2.6; 95% CI 1.0-6.9) and occupational status of the household head being a civil servant (adjusted OR = 2.7; 95% CI 0.9-7.9). About 7.8% (95% CI 6.7-10.0%) of all SAC participated in the study and 40.4% (95% CI 57.4-66.7%) of children in households owning at least one LLIN passed the previous night under LLIN. LLIN utilization by SAC conditional to presence of at least one net in the household was significantly correlated with education level of mother above grade 6 (adjusted OR = 3.4; 95% CI 1.3-9.3) and the household size to bed net ratio less than or equal to 2 (adjusted OR = 20.7; 95% CI 4.7-132.5). CONCLUSION: Ownership of bed net was lower than universal coverage of at least one bed net for two individuals. It is important to monitor replacement needs and educate mothers with low education level with their SAC on the benefit of consistent utilization of bed nets.

Fetal biometry assessment with Intergrowth 21st's and Salomon's equations in rural Burkina Faso.

BACKGROUND: Ultrasound scanning during the 2nd or the 3rd trimester of pregnancy for fetal size disturbances screening is heavily dependent of the choice of the reference chart. This study aimed to assess the agreement of Salomon and the Intergrowth 21st equations in evaluating fetal biometric measurements in a rural area of Burkina Faso, and to measure the effect of changing a reference chart. METHODS: Data collected in Nazoanga, Burkina Faso, between October 2010 and October 2012, during a clinical trial evaluating the safety and efficacy of several antimalarial treatments in pregnant women were analyzed. We included singleton pregnancies at 16-36 weeks gestation as determined by ultrasound measurements of fetal bi-parietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femur length (FL). Expected mean and standard deviation at a given gestational age was computed using equations from Salomon references and using Intergrowth 21st standard. Then, z-scores were calculated and used subsequently to compare Salomon references with Intergrowth 21st standards. RESULTS: The analysis included 276 singleton pregnancies. Agreement was poor except for HC: mean difference - 0.01, limits of agreement - 0.60 and 0.59. When AC was used as a surrogate of fetal size, switching from the reference of Salomon to the standards of Intergrowth 21st increased ten times the proportion of fetuses above the 90th percentile: 2.9 and 31.2%, respectively. Mean differences were larger in the third trimester than in the second trimester. However, agreement remained good for HC in both trimesters. Difference in the proportion of AC measurements above the 90th percentile using Salomon and Intergrowth 21st equations was greater in the second trimester (2.6 and 36.3%, respectively) than in the third trimester (3.5 and 19.8%, respectively). The greatest difference between the two charts was observed in the number of FL measurements classified as large in the second trimester (6.8 and 54.2%, using Salomon and Intergrowth 21st equations, respectively). CONCLUSION: The agreement between Intergrowth 21st and Salomon equations is poor apart from HC. This would imply different clinical decision regarding the management of the pregnancy.

Correlates of knowledge of family planning among people living in fishing communities of Lake Victoria, Uganda.

BACKGROUND: Knowledge of family planning (FP) is a key determinant of contraceptive use which ultimately plays a role in attainment of good health and in conduct of clinical research. People living in fishing communities (FCs) have limited access to health services including FP and are targeted for future clinical research but their knowledge of FP and its correlates are scantily known. We determined correlates of knowledge of FP among people living in FCs of L. victoria in Uganda to inform future FP education programs in FCs. METHODS: We conducted a comparative cross-sectional survey among participants aged 15-49 years from Kigungu and Nsazi. Participants were asked if they were aware of any FP method. All those who responded in the affirmative were further asked to mention what FP methods they had heard of or knew. Those who reported knowledge of at least one FP method were asked a series of questions about FP methods and their side effects. Knowledge was categorized into good or poor knowledge based on their mean total score. Poor knowledge constituted a score below the mean while good knowledge constituted a score of more than or equal to the mean total score. To further explore attitudes and perceptions of FP, ten in-depth interviews and four focus group discussions were conducted. RESULTS: Of the 1410 screened participants, 94.5% were aware of at least one FP method. Pills and injectable hormonal methods were the most commonly known methods. Slightly over a third (38%) had good knowledge of FP. Correlates of knowledge of FP were; being female (aOR: 1.92 95% CI: 1.39-2.67), residing in Kigungu (aOR: 4.01 95% CI: 2.77-5.81), being married (aOR: 1.59 95% CI: 1.11-2.28) and currently being in a sexual relationship (aOR: 1.75 95% CI: 1.18-2.60). Concerns about safety and effectiveness of some modern FP methods exist. Misconceptions on effects of FP like sterility, cancers and foetal abnormalities were common. CONCLUSION: FP awareness among people living in FCs of L. Victoria in Uganda is high. However, good knowledge about specific methods tends to be low. Correlates of knowledge of FP include gender, residence, marital status and sexual engagement.