Potential population-level effects of HIV self-test distribution among key populations in Côte d'Ivoire, Mali, and Senegal: a mathematical modelling analysis.

BACKGROUND: During 2019-21, the AutoTest VIH, Libre d'accéder à la connaissance de son Statut (ATLAS) programme distributed around 380 000 HIV self-testing kits to key populations, including female sex workers, men who have sex with men, and their partners, in Côte d'Ivoire, Mali, and Senegal. We aimed to estimate the effects of the ATLAS programme and national scale-up of HIV self-test distribution on HIV diagnosis, HIV treatment coverage, HIV incidence, and HIV-related mortality. METHODS: We adapted a deterministic compartmental model of HIV transmission in Côte d'Ivoire, parameterised and fitted to country-specific demographic, behavioural, HIV epidemiological, and intervention data in Côte d'Ivoire, Mali, and Senegal separately during 1980-2020. We simulated dynamics of new HIV infections, HIV diagnoses, and HIV-related deaths within scenarios with and without HIV self-test distribution among key populations. Models were separately parameterised and fitted to country-specific sets of epidemiological and intervention outcomes (stratified by sex, risk, age group, and HIV status, if available) over time within a Bayesian framework. We estimated the effects on the absolute increase in the proportion of people with HIV diagnosed at the end of 2021 for the ATLAS-only scenario and at the end of 2028 and 2038 for the HIV self-testing scale-up scenario. We estimated cumulative numbers of additional HIV diagnoses and initiations of antiretroviral therapy and the proportion and absolute numbers of new HIV infections and HIV-related deaths averted during 2019-21 and 2019-28 for the ATLAS-only scenario and during 2019-28 and 2019-38 for the HIV self-testing scale-up scenario. FINDINGS: Our model estimated that ATLAS could have led to 700 (90% uncertainty interval [UI] 500-900) additional HIV diagnoses in Côte d'Ivoire, 500 (300-900) in Mali, and 300 (50-700) in Senegal during 2019-21, a 0·4 percentage point (90% UI 0·3-0·5) increase overall by the end of 2021. During 2019-28, ATLAS was estimated to avert 1900 (90% UI 1300-2700) new HIV infections and 600 (400-800) HIV-related deaths across the three countries, of which 38·6% (90% UI 31·8-48·3) of new infections and 70·1% (60·4-77·3) of HIV-related deaths would be among key populations. ATLAS would avert 1·5% (0·8-3·1) of all HIV-related deaths across the three countries during this period. Scaling up HIV self-testing would avert 16·2% (90% UI 10·0-23·1) of all new HIV infections during 2019-28 in Senegal, 5·3% (3·0-8·9) in Mali, and 1·6% (1·0-2·4) in Côte d'Ivoire. HIV self-testing scale-up among key populations was estimated to increase HIV diagnosis by the end of 2028 to 1·3 percentage points (90% UI 0·8-1·9) in Côte d'Ivoire, 10·6 percentage points (5·3-16·8) in Senegal, and 3·6 percentage points (2·0-6·4) in Mali. INTERPRETATION: Scaling up HIV self-test distribution among key populations in western Africa could attenuate disparities in access to HIV testing and reduce infections and deaths among key populations and their partners. FUNDING: Unitaid, Solthis, the UK Medical Research Council Centre for Global Infectious Disease Analysis, the EU European & Developing Countries Clinical Trials Partnership programme, and the Wellcome Trust. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.

Population genetic structure of Schistosoma bovis and S. curassoni collected from cattle in Mali.

Schistosomiasis is of medical and veterinary importance. Despite the critical situation of schistosomiasis in sub-Saharan Africa, few molecular epidemiological studies have been carried out to determine the role of animals in its transmission. In Mali, it has been over three decades since the last molecular study of animal schistosomes was carried out. It is now urgent to identify circulating strains of the parasite because of potential interactions with other schistosome species, which could complicate disease control. The aim of our work was to study the composition and genetic structure of schistosome populations collected from cattle. The prevalence of schistosome was 23.9%, with the prevalences of Schistosoma bovis (Sb) and S. curassoni (Sc) estimated at 12.6% and 9.8%, respectively. No hybrid strains or S. haematobium were found. The parasites displayed distinct geographical distribution with Sb dominant in Bamako (78.8% and 98% in Central Bamako Slaughterhouse and Sabalibougou Slaughterhouses, respectively) and Sc dominant in Kayes (95.3%). Of the 476 parasites with a complete genetic profile, 60.4% were pure Sc, and were mainly from Kayes. We identified two clusters at the site level (Fst of 0.057 and 0.042 for Sb and Sc, respectively). Cluster 1 was predominantly composed of pure Sb parasites and cluster 2 was mainly composed of pure Sc parasites, from Bamako and Kayes, respectively. Our study shows that cattle schistosomiasis remains endemic in Mali with S. bovis and S. curassoni. A robust genetic structure between the different schistosome populations was identified, which included two clusters based on the geographical distribution of the parasites.

Title: Structure génétique des populations de Schistosoma bovis et S. curassoni collectées chez des bovins au Mali. Abstract: La schistosomiase revêt une grande importance médicale et vétérinaire. Malgré la situation critique de la schistosomiase en Afrique subsaharienne, peu d'études épidémiologiques moléculaires ont été réalisées pour déterminer le rôle des animaux dans sa transmission. Au Mali, cela fait plus de trois décennies que la dernière étude moléculaire des schistosomes animaux a été réalisée. Il est désormais urgent d'identifier les souches circulantes du parasite en raison des interactions potentielles avec d'autres espèces de schistosomes, ce qui pourrait compliquer la lutte contre la maladie. Le but de notre travail était d'étudier la composition et la structure génétique des populations de schistosomes collectées chez des bovins. La prévalence des schistosomes était de 23,9 %, celles de Schistosoma bovis (Sb) et de S. curassoni (Sc) étant respectivement estimées à 12,6 % et 9,8 %. Aucune souche hybride ni S. haematobium n'ont été trouvés. Les parasites présentaient une répartition géographique distincte avec Sb dominant à Bamako (respectivement 78,8 % et 98 % aux Abattoirs Centraux de Bamako et aux Abattoirs de Sabalibougou) et Sc dominant à Kayes (95,3 %). Sur les 476 parasites ayant un profil génétique complet, 60,4 % étaient des Sc purs, et provenaient principalement de Kayes. Nous avons identifié deux clusters au niveau du site (Fst de 0,057 et 0,042 pour Sb et Sc, respectivement). Le groupe 1 était principalement composé de parasites Sb purs et le groupe 2 était principalement composé de parasites Sc purs, provenant respectivement de Bamako et de Kayes. Notre étude montre que la schistosomiase bovine reste endémique au Mali, avec S. bovis and S. curassoni. Une structure génétique robuste entre les différentes populations de schistosomes a été identifiée, comprenant deux groupes basés sur la répartition géographique des parasites.

Seroprevalence of SARS-CoV-2 Antibodies and Associated Factors in Bamako, Mali: A Population-Based Cross-Sectional Study in September 2022.

BACKGROUND: The sero-epidemiological characteristics of SARS-CoV-2 infections in Mali are not yet well understood. This study assessed SARS-CoV-2 antibody seroprevalence and factors associated with antibody responses in the general population of Bamako, the capital city and epicenter of COVID-19, to assess the magnitude of the pandemic and contribute to control strategy improvements in Mali. METHODS: A cross-sectional survey was conducted in September 2022 to collect sociodemographic information, clinical characteristics, comorbid factors, and blood samples. ELISA was performed to determine anti-Spike (anti-S) and anti-RBD antibody levels. A total of 3601 participants were enrolled in REDCap. R-Studio was used for the statistical analysis. The chi-squared (χ2) test was used to compare the proportions across different groups. Logistic regression models were used to elucidate factors associated with antibody responses. RESULT: The sex ratio for female-to-male was 3.6:1. The most representative groups were the 20-29-year-olds (28.9%, n = 1043) and the 30-39-year-olds (26.9%, n = 967). The COVID-19 vaccine coverage among the participants was 35.8%, with vaccines from Covishield AstraZeneca (13.4%), Johnson & Johnson (16.7%), Sinovac (3.9%), and BioNTech Pfizer (1.8%). Overall, S protein and RBD antibody seroprevalences were remarkably high in the study population (98% and 97%, respectively). Factors such as youth (1-9 years old) and male sex were associated with lower SARS-CoV-2 antibody responses, whereas COVID-19 vaccinations were associated with increased antibody responses. CONCLUSION: This serosurvey demonstrated the high seroprevalence of SARS-CoV-2 antibodies and highlighted the factors influencing antibody responses, while clearly underlining an underestimation of the pandemic in Mali.

Cost-effectiveness analysis of community-led HIV self-testing among key populations in Côte d'Ivoire, Mali, and Senegal.

INTRODUCTION: HIV self-testing (HIVST) is a promising strategy to improve diagnosis coverage among key populations (KP). The ATLAS (Auto Test VIH, Libre d'Accéder à la connaissance de son Statut) programme implemented HIVST in three West African countries, distributing over 380,000 kits up between 2019 and 2021, focussing on community-led distribution by KP to their peers and subsequent secondary distribution to their partners and clients. We aim to evaluate the cost-effectiveness of community-led HIVST in Côte d'Ivoire, Mali and Senegal. METHODS: An HIV transmission dynamics model was adapted and calibrated to country-specific epidemiological data and used to predict the impact of HIVST. We considered the distribution of HIVST among two KP-female sex workers (FSW), and men who have sex with men (MSM)-and their sexual partners and clients. We compared the cost-effectiveness of two scenarios against a counterfactual without HIVST over a 20-year horizon (2019-2039). The ATLAS-only scenario mimicked the 2-year implemented ATLAS programme, whereas the ATLAS-scale-up scenario achieved 95% coverage of HIVST distribution among FSW and MSM by 2025 onwards. The primary outcome is the number of disability-adjusted life-years (DALY) averted. Scenarios were compared using incremental cost-effectiveness ratios (ICERs). Costing was performed using a healthcare provider's perspective. Costs were discounted at 4%, converted to $USD 2022 and estimated using a cost-function to accommodate economies of scale. RESULTS: The ATLAS-only scenario was highly cost-effective over 20 years, even at low willingness-to-pay thresholds. The median ICERs were $126 ($88-$210) per DALY averted in Côte d'Ivoire, $92 ($88-$210) in Mali and 27$ ($88-$210) in Senegal. Scaling-up the ATLAS programme would also be cost-effective, and substantial epidemiological impacts would be achieved. The ICERs for the scale-up scenario were $199 ($122-$338) per DALY averted in Côte d'Ivoire, $224 ($118-$415) in Mali and $61 ($18-$128) in Senegal. CONCLUSIONS: Both the implemented and the potential scale-up of community-led HIVST programmes in West Africa, where KP are important to overall transmission dynamics, have the potential to be highly cost-effective, as compared to a scenario without HIVST. These findings support the scale-up of community-led HIVST to reach populations that otherwise may not access conventional testing services.

Seroprevalence of Arboviruses in a Malaria Hyperendemic Area in Southern Mali.

Diagnostics for febrile illnesses other than malaria are not readily available in rural sub-Saharan Africa. This study assessed exposure to three mosquito-borne arboviruses-dengue virus (DENV), Zika virus (ZIKV), and chikungunya virus (CHIKV)-in southern Mali. Seroprevalence for DENV, CHIKV, and ZIKV was analyzed by detection of IgG antibodies and determined to be 77.2%, 31.2%, and 25.8%, respectively. Among study participants, 11.3% were IgG-positive for all three arboviruses. DENV had the highest seroprevalence rate at all sites; the highest seroprevalence of CHIKV and ZIKV was observed in Bamba. The seroprevalence for all three arboviruses increased with age, and the highest seroprevalence was observed among adults older than 50 years. The prevalence of Plasmodium spp. in the cohort was analyzed by microscopy and determined to be 44.5% (N = 600) with Plasmodium falciparum representing 95.1% of all infections. This study demonstrates the co-circulation of arboviruses in a region hyperendemic for malaria and highlights the needs for arbovirus diagnostics in rural sub-Saharan Africa.

The burden of headache and a health-care needs assessment in the adult population of Mali: a cross-sectional population-based study.

BACKGROUND: Our recent studies have shown headache disorders to be very common in the central and western sub-Saharan countries of Benin and Cameroon. Here we report headache in nearby Mali, a strife-torn country that differs topographically, culturally, politically and economically. The purposes were to estimate headache-attributed burden and need for headache care. METHODS: We used cluster-random sampling in seven of Mali's eleven regions to obtain a nationally representative sample. During unannounced household visits by trained interviewers, one randomly selected adult member (18-65 years) from each household was interviewed using the structured HARDSHIP questionnaire, with enquiries into headache in the last year and, additionally, headache yesterday (HY). Headache on ≥ 15 days/month (H15+) was diagnosed as probable medication-overuse headache (pMOH) when associated with acute medication use on ≥ 15 days/month, and as "other H15+" when not. Episodic headache (on < 15 days/month) was recorded as such and not further diagnosed. Burden was assessed as impaired participation (days lost from paid and household work, and from leisure activity). Need for headache care was defined by criteria for expectation of benefit. RESULTS: Data collection coincided with the SARS-CoV-2 pandemic. The participating proportion was nonetheless extremely high (99.4%). The observed 1-year prevalence of any headache was 90.9%. Age- and gender-adjusted estimates were 86.3% for episodic headache, 1.4% for pMOH and 3.1% for other H15+. HY was reported by 16.8% with a mean duration of 8.7 h. Overall mean headache frequency was 3.5 days/month. Participants with pMOH lost more days from paid (8.8 days/3 months) and household work (10.3 days/3 months) than those with other H15+ (3.1 and 2.8 days/3 months) or episodic headache (1.2 and 0.9 days/3 months). At population level, 3.6-5.8% of all time was spent with headache, which led to a 3.6% decrease in all activity (impaired participation). Almost a quarter (23.4%) of Mali's adult population need headache care. CONCLUSION: Headache is very common in Mali, as in its near neighbours, Benin and Cameroon, and associated with substantial losses of health and productivity. Need for headache care is high - a challenge for a low-income country - but lost productivity probably translates into lost gross domestic product.

Prognostics of multiple malaria episodes and nutritional status in children aged 6 to 59 months from 2013 to 2017 in Dangassa, Koulikoro region, Mali.

BACKGROUND: In Africa, the relationship between childhood nutritional status and malaria remains complex and difficult to interpret. Understanding it is important in the improvement of malaria control strategies. This study aimed to assess the influence of nutritional status on the occurrence of multiple malaria episodes in children aged 6 to 59 months between 2013 and 2017 living in the village of Dangassa, Mali. METHODS: A community-based longitudinal study was conducted using cross-sectional surveys (CSSs) at the beginning (June) and end (November) of the malaria transmission season associated with passive case detection (PCD) at the Dangassa Community Health Centre. Children with asymptomatic malaria infection during cross-sectional surveys were selected and their malaria episodes followed by PCD. Malaria indicators in person-months were estimated using an ordinal-logistic model repeated on subjects during follow-up periods. RESULTS: The incidence rate (IR) during the period of high transmission (June to October), for 1 episode and for 2 + episodes peaked in 2013 with 65 children (IR = 95.73 per 1000 person-months) and 24 cases (IR = 35.35 per 1000 person-months), respectively. As expected, the risk of multiple episodes occurring during the period of high transmission was 3.23 compared to the period of low transmission after adjusting for other model parameters (95% CI [2.45-4.26], p = 0.000). Children with anaemia were at high risk of having multiple episodes (OR = 1.6, 95% CI [1.12-2.30], p = 0.011). However, the risk of having 2 + episodes for anemic children was higher during the period of low transmission (RR = 1.67, 95% CI [1.15-2.42], p = 0.007) compared to the period of high transmission (RR = 1.58, 95% CI [1.09-2.29], p = 0.016). The trend indicated that anemic and underweight children were significantly associated with multiple malaria episodes during the period of low transmission (p < 0.001). CONCLUSION: Results show that multiple episodes of malaria are significantly related to the nutritional status (anaemia and underweight) of the child during the two transmission seasons and more pronounced during the dry season (period of low transmission). Further research including other malnutrition parameters will be needed to confirm these findings.

Multiplex PCR for bacterial, viral and protozoal pathogens in persistent diarrhoea or persistent abdominal pain in Côte d'Ivoire, Mali and Nepal.

In contrast to acute diarrhoea, the aetiology of persistent digestive disorders (≥ 14 days) is poorly understood in low-resource settings and conventional diagnostic approaches lack accuracy. In this multi-country study, we compared multiplex real-time PCR for enteric bacterial, parasitic and viral pathogens in stool samples from symptomatic patients and matched asymptomatic controls in Côte d'Ivoire, Mali and Nepal. Among 1826 stool samples, the prevalence of most pathogens was highest in Mali, being up to threefold higher than in Côte d'Ivoire and up to tenfold higher than in Nepal. In all settings, the most prevalent bacteria were EAEC (13.0-39.9%) and Campylobacter spp. (3.9-35.3%). Giardia intestinalis was the predominant intestinal protozoon (2.9-20.5%), and adenovirus 40/41 was the most frequently observed viral pathogen (6.3-25.1%). Significantly different prevalences between symptomatic and asymptomatic individuals were observed for Campylobacter, EIEC and ETEC in the two African sites, and for norovirus in Nepal. Multiple species pathogen infection was common in Côte d'Ivoire and Mali, but rarely found in Nepal. We observed that molecular testing detected multiple enteric pathogens and showed low discriminatory accuracy to distinguish between symptomatic and asymptomatic individuals. Yet, multiplex PCR allowed for direct comparison between different countries and revealed considerable setting-specificity.

Assessment of the impact of pregnancy and malaria infection on the variation of neutrophil levels in women from San, Mali.

BACKGROUND: In patients with severe neutropenia, infections can rapidly become serious and life-threatening. It is essential to understand whether pregnancy induces changes in neutrophil levels thereby posing an increased threat to the health of gravidae. METHODOLOGY: This cross-sectional study was conducted in San Health District (Mali) and involved pregnant women infected or not by malaria parasites and non-pregnant healthy volunteers. Subjects were categorized as having neutropenia, normal neutrophil levels, and neutrophilia regarding their neutrophil levels. A logistic regression analysis was performed to determine factors associated with neutrophil level variation in pregnant women. RESULTS: Whether or not the pregnant women were infected with malaria, 98 of the 202 cases (48.5%) showed neutrophilia. Surprisingly, 67 of the 71 cases of neutropenia (94.4%) observed in this study concerned healthy people who were not pregnant. The mean percentage of neutrophil levels was significantly (p < 0.001) lower (49.9%) in the first trimester compared to the second trimester of pregnancy (62.0%). A logistic regression model showed that compared to early pregnancy, the second (OR = 12.9, 95% CI 2.2-248.1, p = 0.018) and the third trimesters (OR = 13.7, 95% CI 2.3-257.5, p = 0.016) were strongly associated with the increase of neutrophil levels. CONCLUSIONS: Pregnancy can induce the production of mature neutrophils that are continually released into circulation. Neutrophil levels were lower during the first trimester of the pregnancy compared to the second and third trimesters, but not affected by the presence or absence of malaria infection.

Prevalence of high-risk human papillomavirus genotypes in outpatient Malian women living with HIV: a pilot study.

INTRODUCTION: Long-term exposure to high-risk human papillomavirus (Hr-HPV) is a well-known necessary condition for development of cervical cancer. The aim of this study is to screen for Hr-HPV using vaginal self-sampling, which is a more effective approach to improve women's adherence and increase screening rates. METHODS: This pilot study included a total of 100 Women living with HIV (WLWHIV), recruited from the Center for Listening, Care, Animation, and Counseling of People Living with HIV in Bamako. Hr-HPV genotyping was performed on Self-collected samples using the Cepheid GeneXpert instrument. RESULTS: The median age of WLWHIV was 44 (interquartile range [IQR], 37-50) years. Approximately 92% of the study participants preferred self-sampling at the clinic, and 90% opted to receive result notifications via mobile phone contact. The overall prevalence of Hr-HPV among study participants was 42.6%, and the most frequent Hr-HPV sub-types observed were HPV18/45 (19.1%), HPV31/35/33/52/58 (13.8%), and HPV39/68/56/66 (12.8%), followed by HPV16 (5.3%), and HPV51/59 (5.3%). WLWHIV under 35 years of age had a higher frequency of Hr-HPV compared to their older counterparts, with rates of 30% versus 11.1% (p = 0.03). The duration of antiretroviral treatment showed an inverse association with Hr-HPV negativity, with patients on treatment for 15 (IQR, 10-18) years versus 12 (IQR = 7-14) years for Hr-HPV positive patients (95% CI [1.2-5.8], t = 3.04, p = 0.003). WLWHIV with baseline CD4 T-Cell counts below 200 exhibited a higher frequency of Hr-HPV compared to those with baseline CD4 T-Cell counts above 200 (17.9% versus 1.9%, p = 0.009). However, other demographics and clinical factors, such as marital status, age of sexual debut, parity, education, history of abortion, history of preeclampsia, and cesarean delivery, did not influence the distribution of Hr-HPV genotypes. CONCLUSION: Our findings indicate that WLWHIV under the age of 35 years old exhibited the highest prevalence of Hr-HPV infection, with HPV18/45 being the most prevalent subtype. Additionally, WLWHIV with baseline CD4 T-Cell counts below 200 showed the highest infection rates.

Artemether-lumefantrine with or without single-dose primaquine and sulfadoxine-pyrimethamine plus amodiaquine with or without single-dose tafenoquine to reduce Plasmodium falciparum transmission: a phase 2, single-blind, randomised clinical trial in Ouelessebougou, Mali.

BACKGROUND: Artemether-lumefantrine is widely used for uncomplicated Plasmodium falciparum malaria; sulfadoxine-pyrimethamine plus amodiaquine is used for seasonal malaria chemoprevention. We aimed to determine the efficacy of artemether-lumefantrine with and without primaquine and sulfadoxine-pyrimethamine plus amodiaquine with and without tafenoquine for reducing gametocyte carriage and transmission to mosquitoes. METHODS: In this phase 2, single-blind, randomised clinical trial conducted in Ouelessebougou, Mali, asymptomatic individuals aged 10-50 years with P falciparum gametocytaemia were recruited from the community and randomly assigned (1:1:1:1) to receive either artemether-lumefantrine, artemether-lumefantrine with a single dose of 0·25 mg/kg primaquine, sulfadoxine-pyrimethamine plus amodiaquine, or sulfadoxine-pyrimethamine plus amodiaquine with a single dose of 1·66 mg/kg tafenoquine. All trial staff other than the pharmacist were masked to group allocation. Participants were not masked to group allocation. Randomisation was done with a computer-generated randomisation list and concealed with sealed, opaque envelopes. The primary outcome was the median within-person percent change in mosquito infection rate in infectious individuals from baseline to day 2 (artemether-lumefantrine groups) or day 7 (sulfadoxine-pyrimethamine plus amodiaquine groups) after treatment, assessed by direct membrane feeding assay. All participants who received any trial drug were included in the safety analysis. This study is registered with ClinicalTrials.gov, NCT05081089. FINDINGS: Between Oct 13 and Dec 16, 2021, 1290 individuals were screened and 80 were enrolled and randomly assigned to one of the four treatment groups (20 per group). The median age of participants was 13 (IQR 11-20); 37 (46%) of 80 participants were female and 43 (54%) were male. In individuals who were infectious before treatment, the median percentage reduction in mosquito infection rate 2 days after treatment was 100·0% (IQR 100·0-100·0; n=19; p=0·0011) with artemether-lumefantrine and 100·0% (100·0-100·0; n=19; p=0·0001) with artemether-lumefantrine with primaquine. Only two individuals who were infectious at baseline infected mosquitoes on day 2 after artemether-lumefantrine and none at day 5. By contrast, the median percentage reduction in mosquito infection rate 7 days after treatment was 63·6% (IQR 0·0-100·0; n=20; p=0·013) with sulfadoxine-pyrimethamine plus amodiaquine and 100% (100·0-100·0; n=19; p<0·0001) with sulfadoxine-pyrimethamine plus amodiaquine with tafenoquine. No grade 3-4 or serious adverse events occurred. INTERPRETATION: These data support the effectiveness of artemether-lumefantrine alone for preventing nearly all mosquito infections. By contrast, there was considerable post-treatment transmission after sulfadoxine-pyrimethamine plus amodiaquine; therefore, the addition of a transmission-blocking drug might be beneficial in maximising its community impact. FUNDING: Bill & Melinda Gates Foundation.

Anal disorders in pregnant and postpartum women: epidemiological, diagnostic and therapeutic aspects in 10 maternities of Bamako in Mali.

Bowel transit disturbances favored by pregnancy and injuries during childbirth would be triggering or aggravating factors for anal pathologies. The objective of this work was to study the epidemiology, diagnosis, and treatment of anal pathologies during pregnancy and 6 weeks after delivery. We carried out a prospective, multi-centric, and analytical study in 10 obstetric units in Bamako from June 1st, 2019, to May 31st, 2020. After informed consent, we enrolled all first-trimester pregnant women admitted to the hospitals and who were followed up through the postpartum. We conducted a rectal examination in each participant and an anoscope in those with an anal symptom. Hemorrhoidal diseases were diagnosed in the case of external hemorrhoids (thrombosis or prolapse) or internal hemorrhoids. During the study period, we followed up 1,422 pregnant women and we found 38.4% (546) with anal pathologies (hemorrhoidal diseases in 13% (192), anal fissure in 10.5% (150) and anal incontinence in 8.6% (123). Risk factors for the hemorrhoidal disease were age of patient ≥30 years old aRR=5.77, 95% CI 4.57-7.34; p=0.000; a existence of chronic constipation aRR=2.61, 95% CI 1.98-3.44; p=0.000; newborn weight >3500 g aRR= 1.61, 95% CI 1.25-2.07; p=0.000 and fetal expulsion time >20 minutes aRR= 6.04, 95% CI 5.07-7.27; p=0.000. The clinical signs observed were constipation, anal pain, bleeding, and pruritus. The treatment was based on counseling on hygiene and diet, the use of laxatives, local topicals, and analgesics along perineal rehabilitation. Anal pathologies were common during pregnancy and 6 weeks after delivery. Pregnant women must be screened systematically for such pathologies. Early diagnostic and appropriate treatment would reduce serious complications.

Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria.

BACKGROUND: Subcutaneous administration of the monoclonal antibody L9LS protected adults against controlled Plasmodium falciparum infection in a phase 1 trial. Whether a monoclonal antibody administered subcutaneously can protect children from P. falciparum infection in a region where this organism is endemic is unclear. METHODS: We conducted a phase 2 trial in Mali to assess the safety and efficacy of subcutaneous administration of L9LS in children 6 to 10 years of age over a 6-month malaria season. In part A of the trial, safety was assessed at three dose levels in adults, followed by assessment at two dose levels in children. In part B of the trial, children were randomly assigned, in a 1:1:1 ratio, to receive 150 mg of L9LS, 300 mg of L9LS, or placebo. The primary efficacy end point, assessed in a time-to-event analysis, was the first P. falciparum infection, as detected on blood smear performed at least every 2 weeks for 24 weeks. A secondary efficacy end point was the first episode of clinical malaria, as assessed in a time-to-event analysis. RESULTS: No safety concerns were identified in the dose-escalation part of the trial (part A). In part B, 225 children underwent randomization, with 75 children assigned to each group. No safety concerns were identified in part B. P. falciparum infection occurred in 36 participants (48%) in the 150-mg group, in 30 (40%) in the 300-mg group, and in 61 (81%) in the placebo group. The efficacy of L9LS against P. falciparum infection, as compared with placebo, was 66% (adjusted confidence interval [95% CI], 45 to 79) with the 150-mg dose and 70% (adjusted 95% CI, 50 to 82) with the 300-mg dose (P<0.001 for both comparisons). Efficacy against clinical malaria was 67% (adjusted 95% CI, 39 to 82) with the 150-mg dose and 77% (adjusted 95% CI, 55 to 89) with the 300-mg dose (P<0.001 for both comparisons). CONCLUSIONS: Subcutaneous administration of L9LS to children was protective against P. falciparum infection and clinical malaria over a period of 6 months. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT05304611.).

Factors influencing pregnancy care and institutional delivery in rural Mali: a secondary baseline analysis of a cluster-randomised trial.

OBJECTIVE: The vast majority of the 300 000 pregnancy-related deaths every year occur in South Asia and sub-Saharan Africa. Increased access to quality antepartum and intrapartum care can reduce pregnancy-related morbidity and mortality worldwide. We used a population-based cross-sectional cohort design to: (1) examine the sociodemographic risk factors and structural barriers associated with pregnancy care-seeking and institutional delivery, and (2) investigate the influence of residential distance to the nearest primary health facility in a rural population in Mali. METHODS: A baseline household survey of Malian women aged 15-49 years was conducted between December 2016 and January 2017, and those who delivereda baby in the 5 years preceding the survey were included. This study leverages the baseline survey data from a cluster-randomised controlled trial to conduct a secondary analysis. The outcomes were percentage of women who received any antenatal care (ANC) and institutional delivery; total number of ANC visits; four or more ANC visits; first ANC visit in the first trimester. RESULTS: Of the 8575 women in the study, two-thirds received any ANC in their last pregnancy, one in 10 had four or more ANC visits and among those that received any ANC, about one-quarter received it in the first trimester. For every kilometre increase in distance to the nearest facility, the likelihood of the outcomes reduced by 5 percentage points (0.95; 95% CI 0.91 to 0.98) for any ANC; 4 percentage points (0.96; 95% CI 0.94 to 0.98) for an additional ANC visit; 10 percentage points (0.90; 95% CI 0.86 to 0.95) for four or more ANC visits; 6 percentage points (0.94; 95% CI 0.94 to 0.98) for first ANC in the first trimester. In addition, there was a 35 percentage points (0.65; 95% CI 0.56 to 0.76) decrease in likelihood of institutional delivery if the residence was within 6.5 km to the nearest facility, beyond which there was no association with the place of delivery. We also found evidence of increase in likelihood of receiving any ANC care and its intensity increased with having some education or owning a business. CONCLUSION: The findings suggest that education, occupation and distance are important determinants of pregnancy and delivery care in a rural Malian context. TRIAL REGISTRATION NUMBER: NCT02694055.

Normal Clinical Laboratory Ranges by Age and Sex, and Impact on Study Screening Outcomes in Rural Mali.

The interpretation of a laboratory test result requires an appropriate reference range established in healthy subjects, and normal ranges may vary by factors such as geographic region, sex, and age. We examined hematological and clinical chemistry parameters in healthy residents at two rural vaccine trial sites: Bancoumana and Doneguebougou in Mali, West Africa. During screening of clinical studies in 2018 and 2019, peripheral blood samples from 1,192 apparently healthy individuals age 6 months to 82 years were analyzed at a laboratory accredited by the College of American Pathologists for a complete blood count, and creatinine and/or alanine aminotransferase levels. Based on manufacturers' reference range values, which are currently used in Malian clinical laboratories, abnormal values were common in this healthy population. In fact, 30.4% of adult participants had abnormal neutrophil levels and 19.8% had abnormal hemoglobin levels. Differences by sex were observed in those who were older, but not in those younger than 10 years, for several parameters, including hemoglobin, platelet, and absolute neutrophil counts in hematology, and creatinine in biochemistry. The site-specific reference intervals we report can be used in malaria vaccine clinical trials and other interventional studies, as well as in routine clinical care, to identify abnormalities in hematological and biochemical parameters among healthy Malian trial participants.

Female genital mutilation/cutting among girls aged 0-14: evidence from the 2018 Mali Demographic and Health Survey data.

BACKGROUND: Female genital mutilation/cutting (FGM/C) is considered a social norm in many African societies, with varying prevalence among countries. Mali is one of the eight countries with very high prevalence of FGM/C in Africa. This study assessed the individual and contextual factors associated with female FGM/C among girls aged 0-14 years in Mali. METHODS: We obtained data from the 2018 Mali Demographic and Health Survey. The prevalence of FGM/C in girls was presented using percentages while a multilevel binary logistic regression analysis was conducted to assess the predictors of FGM/C and the results were presented using adjusted odds ratios with associated 95% confidence intervals (CIs). RESULTS: The results indicate that more than half (72.7%, 95% CI = 70.4-74.8) of women in Mali with daughters had at least one daughter who has gone through circumcision. The likelihood of circumcision of girls increased with age, with women aged 45-49 having the highest odds compared to those aged 15-19 (aOR = 17.68, CI = 7.91-31.79). A higher likelihood of FGM/C in daughters was observed among women who never read newspaper/magazine (aOR = 2.22, 95% CI = 1.27-3.89), compared to those who read newspaper/magazine at least once a week. Compared to women who are not circumcised, those who had been circumcised were more likely to have their daughters circumcised (aOR = 53.98, 95% CI = 24.91-117.00). CONCLUSION: The study revealed the age of mothers, frequency of reading newspaper/magazine, and circumcision status of mothers, as factors associated with circumcision of girls aged 0-14 in Mali. It is, therefore, imperative for existing interventions and new ones to focus on these factors in order to reduce FGM/C in Mali. This will help Mali to contribute to the global efforts of eliminating all harmful practices, such as child, early and forced marriage and female genital mutilation by 2030.

Evaluation of the Performance of Rapid Diagnostic Tests for Malaria Diagnosis and Mapping of Different Plasmodium Species in Mali.

BACKGROUND: The first-line diagnosis of malaria in Mali is based on the use of rapid diagnostic tests (RDT) that detect the Histidin Rich Protein 2 (HRP2) antigen specific to Plasmodium falciparum. Our study, based on a real-time polymerase chain reaction (qPCR) gold standard, aimed to describe the distribution of the Plasmodium species in each administrative region of Mali and to assess the performance of RDTs. METHODS: We randomly selected 150 malaria-negative and up to 30 malaria-positive RDTs in 41 sites distributed in 9 regions of Mali. DNA extracted from the RDT nitrocellulose strip was assayed with a pan-Plasmodium qPCR. Positive samples were then analyzed with P. falciparum-, P. malariae-, P. vivax-, or P. ovale-specific qPCRs. RESULTS: Of the 1496 RDTs, 258 (18.6%) were positive for Plasmodium spp., of which 96.9% were P. falciparum. The P. vivax prevalence reached 21.1% in the north. RDT displayed acceptable diagnostic indices; the lower CI95% bounds of Youden indices were all ≥0.50, except in the north (Youden index 0.66 (95% CI [0.44-0.82]) and 0.63 (95% CI [0.33-0.83]. CONCLUSIONS: Overall, RDT diagnostic indices are adequate for the biological diagnosis of malaria in Mali. We recommend the use of RDTs detecting P. vivax-specific antigens in the north.

Determinants of household-, maternal- and child-related factors associated with nutritional status among children under five in Mali: evidence from a Demographic and Health Survey, 2018.

OBJECTIVE: The current study aims to determine household-, maternal- and child-related factors influencing nutritional status among children under five in Mali. DESIGN: Quantitative cross-sectional study using secondary data extracted from Mali DHS-VI 2018. SETTING: Urban and rural areas of Mali. PARTICIPANTS: A total of 8908 children participated, with 3999 in the younger age group (0-24 months) and 4909 in the older age group (25-59 months). RESULTS: In the younger age group, the prevalence of stunting, wasting and underweight was 18·8 % (95 % CI%: 17·5, 20·0), 24·6 % (95 % CI: 23·2, 26·0) and 13·2 % (95 % CI: 12·1, 14·3), respectively, while in the older age group, it was 24·9 % (95 % CI: 23·7, 26·2), 22·7 % (95 % CI: 21·5, 24·0) and 5·7 % (95 % CI: 5·0, 6·5), respectively. Being average or large size at birth, having piped source of water, receiving Zn, deworming, high maternal BMI, receiving Fe during pregnancy, higher maternal education and being rich were associated with lower odds of one or more form of undernutrition in both groups. On the other hand, children who were anaemic, drank from a bottle, maternal anaemia, current pregnancy of mothers and living in rural areas were associated with higher odds of stunting, wasting or underweight. Interestingly, children who received Fe supplementation had a higher odds of wasting in the younger group but lower odds of all forms of undernutrition in the older group. CONCLUSIONS: This study emphasised the potential risk factors associated with undernutrition in children. Children who consume non-potable water, have mothers with lower levels of education and BMI and reside in rural areas are more likely to experience undernutrition.

Experiences in Improving the Quality of Community-Based Fever Management from Three Malaria-Endemic African Countries.

The WHO affirms that trained, supervised, and supported community health workers (CHWs) can deliver high-quality health services effectively and has called for documentation of enabling factors, needs, and implementation strategies of successful CHW programs. In response, the U.S. President's Malaria Initiative Impact Malaria Project conducted a study to document implementation approaches, best practices, and lessons learned for quality improvement (QI) of community-based fever management in Madagascar, Malawi, and Mali. The team conducted 10 key informant interviews (KIIs) with individuals at national, regional, and district levels using an open-ended interview guide tailored to each level, and a desk review of documents and materials related to community-based QI. Each country's community health landscape and QI approaches were summarized into four categories identified during the KIIs (training, supervision, coaching/mentoring, and review meetings) and compared. Results found that Madagascar, Malawi, and Mali all had well-defined community health strategies that include QI, but countries could not extend their full package of community-based QI approaches to all CHWs as a result of limited human and financial resources. Vertical funding for health programs limits the scope and coverage of QI approaches, especially at the community level. Recommendations from key informants for strengthening community-based QI included integrating QI approaches to improve cost efficiency, to define roles and responsibilities more clearly, to engage communities and all health system levels in implementation, and to digitize QI tools. Increased financial and skilled human resources are needed for community-based QI activities to achieve their intended effect.

Access to oncology care in Mali: a qualitative study on breast cancer.

BACKGROUND: Breast cancer is the most common cancer in terms of incidence and mortality among women worldwide, including in Africa, and a rapid increase in the number of new cases of breast cancer has recently been observed in sub-Saharan Africa. Oncology is a relatively new discipline in many West African countries, particularly Mali; thus, little is known about the current state of cancer care infrastructure and oncology practices in these countries. METHODS: To describe the challenges related to access to oncology care in Mali, we used a qualitative approach, following the Consolidated Criteria for Reporting Qualitative Research (COREQ). Thirty-eight semistructured interviews were conducted with health professionals treating cancer in Mali (n = 10), women with breast cancer (n = 25), and representatives of associations (n = 3), and 40 participant observations were conducted in an oncology unit in Bamako. We used the theoretical framework on access to health care developed by Levesque et al. a posteriori to organise and analyse the data collected. RESULTS: Access to oncology care is partly limited by the current state of Mali's health infrastructure (technical platform failures, repeated strikes in university hospitals, incomplete free health care and the unavailability of medicines) and exacerbated by the security crisis that has been occurring the country since 2012. The lack of specialist doctors, combined with limited screening campaigns and a centralised and fragmented technical platform in Bamako, is particularly detrimental to breast cancer treatment. Women's lack of awareness, lack of information throughout the treatment process, stereotypes and opposition to amputations all play a significant role in their ability to seek and access quality care, leading some women to therapeutically wander and others to want to leave Mali. It also leaves them in debt and jeopardises the future of their children. However, the high level of trust in doctors, the involvement of international actors, the level of social support and the growing influence of civil society on the issue of cancer also represent great current opportunities to fight cancer in Mali. CONCLUSION: Despite the efforts of successive Malian governments and the commitment of international actors, the provision of health care is still limited in the country, entrenching global inequalities in women's bodies.