Influenza vaccine uptake in Tunisia from two high-risk groups' perception and attitudes: a qualitative study.

Background: Pregnant women (PW) and older adult with chronic diseases (ECD) are priority groups for the influenza vaccination. This study was designed to have a better insight into the influenza perceptions and barriers of the vaccine uptake from these groups' perspectives. Methods: This qualitative study consisted of 20 focus group discussions (FGDs) enrolled from five governorates across the country (north, center, and south) between March 18 and July 10, 2019, in urban and rural areas. FGDs were conducted in Arabic (Tunisian dialect) and following the topic guide. Data were transcribed in the local language then translated into English and analyzed using Nvivo12 Software. This permitted the analysis thematic approach, using codes determined by the focus groups. Results: A total of 170 individuals participated in the FGDs (84 ECD and 86 PW). Both groups recognized the weakness of the immune system as key determinant for severity. While PW raised the lack of information about the vaccine, the ECD emphasized accessibility problems. Five main barriers to influenza vaccination were identified: cultural barriers and use of traditional medicine, misleading or lack of information about influenza and the vaccine, advice against its uptake, problems of availability and accessibility of the vaccine as well as mistrust towards the vaccine including adverse effects, vaccine composition and effectiveness. Conclusion: The study provided refined information from the perspectives of users to orient the policies regarding the promotion of influenza vaccine by decision makers among these two high risk groups.

Influenza vaccination knowledge, attitudes, and practices among Tunisian elderly with chronic diseases.

BACKGROUND: Generally, seasonal influenza does not cause severe infection in healthy adults, but for the elderly, an infection can pose a serious health concern. Although several measures can help prevent influenza, vaccination is considered the most effective. This study aimed to assess influenza vaccine uptake among elderly with chronic diseases in Tunisia during the 2018-2019 influenza season, and to identify knowledge, attitudes and barriers associated with influenza vaccine uptake. METHODS: During influenza season of 2018-2019, we conducted a national cross-sectional study among elderly with chronic disease who were attending primary and secondary health care facilities in Tunisia. We collected data regarding practices, general knowledge and attitudes related to influenza and influenza vaccine, using a standardized questionnaire. A multivariate analysis by logistic regression was performed to assess the factors influencing willingness to receive influenza vaccine. RESULTS: Among the 1191 surveyed elderly, 19.4% (95%CI 14.1-21.9) were vaccinated during the 2018-2019 influenza season and 64.7% (61.9-67.3) expressed willingness to be vaccinated in the next season regardless of vaccination status in the 2018-2019 season. Previous vaccination in the 2018-2019 influenza season was the most significantly associated factor with willingness to receive influenza vaccine (adjusted OR = 16.5 [3.7-72.4]). Significant associations were also observed between knowledge of influenza severity for the elderly as well as for those with chronic diseases and willingness to be vaccinated (p < 0.01). Likewise, participants who were convinced by flu vaccine effectiveness and those who were not concerned about vaccine side effects were more likely to be vaccinated (p < 0.001). The main reason that may lead to vaccine acceptance was a doctor's recommendation (41.1%), while the two main reasons that may lead to vaccine refusal were concerns about side effects (71.5%) and a belief that vaccine was ineffective in averting influenza illness (33.9%). Doctors were the most trusted source for information about influenza vaccine (91.5%). CONCLUSION: Our study revealed low influenza vaccination coverage among Tunisian elderly with chronic diseases believed to be at higher risk for severe acute respiratory infections and death if infected with influenza. Treating physicians' role in promoting influenza vaccination in this high-risk group seems to be crucial.

Knowledge, attitudes and uptake related to influenza vaccine among healthcare workers during the 2018-2019 influenza season in Tunisia.

BACKGROUND: The influenza vaccine (IV) is considered the most effective strategy to prevent seasonal influenza infection and annual vaccination of healthcare workers (HCWs) is recommended by the World Health Organization given their high mixing with patients. We assessed IV uptake among HCWs in the 2018-2019 season and explored their knowledge and attitudes regarding influenza immunization. METHODS: A cross-sectional study was conducted in 150 representative Tunisian health facilities from March to May 2019. We recruited 1231 HCWs with direct patient contact using self-weighted multistage sampling. Univariate and multivariate logistic regression analyses permitted to assess the factors associated with IV uptake in the 2018-2019 influenza season. RESULTS: Among 1231 health professionals enrolled in this study, less than half (36.6, 95% confidence interval [CI]: 33.9-39.4) received the IV at least once in their lives and only 15.3% (CI: 13.3-17.4) were vaccinated against influenza in the 2018-2019 influenza season. High confidence regarding IV efficacy, belief about the mandatory character of influenza vaccination for HCWs, and IV uptake in the 4 years preceding the 2018-2019 influenza season were independently associated with higher IV uptake by multivariate analysis. However, participants with high educational level were less likely to receive the IV than those with the lowest educational level. CONCLUSIONS: Our study revealed a low vaccination rate among Tunisian HCWs confirming the importance of tailored education programs targeting this population.

Psycho-social impacts, experiences and perspectives of patients with Cutaneous Leishmaniasis regarding treatment options and case management: An exploratory qualitative study in Tunisia.

Although non-fatal and mostly self-healing in the case of Leishmania (L.) major, cutaneous leishmaniasis (CL) is mainly treated to reduce lesion healing time. Less attention is paid to the improvement of scars, especially in aesthetically relevant areas of the body, which can dramatically affect patients' wellbeing. We explored patients' perspectives about treatment options and the social and psychological burden of disease (lesion and scar). Individual in-depth interviews were conducted with ten confirmed CL patients at two L. major endemic sites in Southern Tunisia (Sidi Bouzid and Gafsa). Participants were selected using a sampling approach along a spectrum covering e.g. age, sex, and clinical presentation. Patients' experiences, opinions and preferences were explored, and their detailed accounts gave an insight on the impact of CL on their everyday lives. The impact of CL was found to be considerable. Most patients were not satisfied with treatment performance and case management. They expected a shorter healing time and better accessibility of the health system. Tolerance of the burden of disease was variable and ranged from acceptance of hidden scars to suicidal thoughts resulting from the fear to become handicapped, and the stress caused by close relatives. Some believed CL to be a form of skin cancer. Unexpectedly, this finding shows the big gap between the perspectives of patients and assumptions of health professionals regarding this disease. This study provided valuable information for better case management emphasizing the importance of improving communication with patients, and accessibility to treatment. It generated context-specific knowledge to policy makers in Tunisia to implement effective case management in a country where access to treatment remains a challenge due to socio-economic and geographic barriers despite a long tradition in CL control.

Patients' preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study.

BACKGROUND: Cutaneous leishmaniasis (CL) is a disease that often affects exposed skin areas and may heal leaving lifelong scars. Patients' expectations from treatment are rarely considered in drug development for CL. An initiative aiming to address shortcomings in clinical trial design and conduct for CL treatments involving the researchers' community is on-going. This manuscript presents patient-preferred outcomes for CL and an assessment on how to consider these in the conduct of future trials. METHODOLOGY/PRINCIPAL FINDINGS: We report preferred treatment outcomes by 74 patients with confirmed CL in endemic regions of Brazil, Burkina Faso, Colombia, Iran, Morocco, Peru and Tunisia during individual in-depth interviews. Beyond outcomes customarily considered in trials (such as lesion appearance and adverse events), patients talked about a large number of outcomes related to quality of life, such as pain, scar formation, and others affecting their work and daily activities. They also reported fears around getting rid of the parasite, disease recurrence, and possible sequelae. CONCLUSIONS/SIGNIFICANCE: The study results provide a rich insight into important outcomes for CL treatments, as well as related topics, from the perspective of a diverse patient population. Among the outcomes identified, we argue that those related to quality of life as well as recurrence should be included to a greater extent for assessment in clinical trials, and discuss the suitability of measurement instruments such as the Dermatology Quality of Life Index (DLQI). Interviews also point out the potential need to address concerns related to parasitological cure or scar formation, such as social stigmatization and disability. In addition, patients should be given information in order to clarify reported misconceptions. This study therefore suggests a methodology for consulting CL patients on outcomes as elements of clinical trial design, and how to incorporate these outcomes in trials. It also discusses how reported outcomes could be addressed in clinical care.

Presence of Sergentomyia (Parrotomyia) lewisi (Diptera: Psychodidae) in Tunisia.

In Tunisia, 17 phlebotomine sand fly species are reported, belonging to genera Phlebotomus and Sergentomyia. However, subsequent to faunal studies and outbreaks of leishmaniasis in different regions of the country, unrecognized sand fly species could exist. Indeed, we report in this study the presence of Sergentomyia (Parrotomyia) lewisiParrot 1948. A brief collection of phlebotomine sand flies was undertaken in August 2016 in Khbina locality, in Sidi Bouzid governorate situated in Central Tunisia, which constitutes an old focus of Zoonotic Cutaneous Leishmaniasis. Sand flies were collected, using CDC light traps that were placed overnight, in different biotopes (inside habitations, outdoors, and within animal shelters). Specimens were collected and morphologically identified. Measurements were taken with an ocular micrometer. Two female specimens of the species Se. (Parrotomyia) lewisi were collected. One specimen is here described and measured. A comparison of its taxonomic characters to the holotype from Sudan and a specimen from Algeria is also presented. This species was until now only reported from Sudan, Ethiopia, Algeria, and Morocco. It is here described for the first time in Tunisia, which raises the Tunisian sand fly fauna to seven subgenera and 18 species.

An international qualitative study exploring patients' experiences of cutaneous leishmaniasis: study set-up and protocol.

INTRODUCTION: Lack of investments in drug development, lack of standardisation of clinical trials and the complexity of disease presentations contribute to the current lack of effective, safe and adapted treatments for cutaneous leishmaniasis (CL). One aspect concerns outcomes affecting patients' quality of life (QoL): these are hardly assessed in trials, despite potential functional and/or aesthetic impairment caused by CL, which typically affects disadvantaged and vulnerable people living in rural areas. Here, we describe the approach used to bring perspectives of patients with CL into designing and assessing treatments. METHODS AND ANALYSIS: This international qualitative study uses interviews with patients to explore their experiences with CL to (1) elicit outcomes and eligibility criteria for clinical trials important to them and (2) to better understand their needs and views about the disease and their requirements and expectations from treatment. Here, we describe the set-up of this collaborative study and the protocol. Data collection is ongoing.The protocol includes study design, preparation, conduct and analysis of individual interviews with approximately 80 patients in seven countries (Burkina Faso, Brazil, two sites in Colombia, Iran, Morocco, Peru and Tunisia) where CL is prevalent. Principal investigators and sites were selected through an open call, and two workshops were organised for protocol development and training in conduct and analysis of qualitative health research. Patient recruitment aims at covering a maximum variation of experiences. Transcripts will be analysed to identify outcomes and eligibility criteria as well as further topics that are expected to emerge from the interviews, such as direct and indirect costs related to CL, its psychological impact, preferred modes of drug administration and traditional treatments. ETHICS AND DISSEMINATION: The study received ethical approval by the responsible committees of each of the participating institutions. Findings will be disseminated through publication in peer-reviewed journals, scientific meetings and to participants and their communities.

Prevalence and determinants of Leishmania major infection in emerging and old foci in Tunisia.

BACKGROUND: Zoonotic Cutaneous Leishmaniasis (ZCL) due to Leishmania major (L. major) is still a serious public health problem in Tunisia. This study aimed to compare the prevalence and risk factors associated with L. major infection in old and new foci using leishmanin skin test (LST) in central Tunisia. METHODS: A cross sectional household survey was carried out between January and May 2009 on a sample of 2686 healthy individuals aged between 5 and 65 years. We determined the prevalence of L. major infection using the LST. Risk factors of LST positivity were assessed using a logistic regression model. RESULTS: The overall prevalence of LST positivity was 57% (95% CI: 53-59). The prevalence of L. major infection was significantly higher in the old focus (99%; 95% CI: 98-100) than in the emerging foci (43%; 95% CI: 39-46) (p = <0.001). Multivariate analysis of LST positivity risk factors showed that age, the nature of the foci (old/emerging), personal and family history of ZCL are determinants of positive LST results. CONCLUSION: The results updated the current epidemiologic profile of ZLC in central Tunisia. Past history of transmission in a population should be considered as a potential confounder in future clinical trials for drugs and vaccines against L. major cutaneous leishmaniasis.

Topical paromomycin with or without gentamicin for cutaneous leishmaniasis.

BACKGROUND: There is a need for a simple and efficacious treatment for cutaneous leishmaniasis with an acceptable side-effect profile. METHODS: We conducted a randomized, vehicle-controlled phase 3 trial of topical treatments containing 15% paromomycin, with and without 0.5% gentamicin, for cutaneous leishmaniasis caused by Leishmania major in Tunisia. We randomly assigned 375 patients with one to five ulcerative lesions from cutaneous leishmaniasis to receive a cream containing 15% paromomycin-0.5% gentamicin (called WR 279,396), 15% paromomycin alone, or vehicle control (with the same base as the other two creams but containing neither paromomycin nor gentamicin). Each lesion was treated once daily for 20 days. The primary end point was the cure of the index lesion. Cure was defined as at least 50% reduction in the size of the index lesion by 42 days, complete reepithelialization by 98 days, and absence of relapse by the end of the trial (168 days). Any withdrawal from the trial was considered a treatment failure. RESULTS: The rate of cure of the index lesion was 81% (95% confidence interval [CI], 73 to 87) for paromomycin-gentamicin, 82% (95% CI, 74 to 87) for paromomycin alone, and 58% (95% CI, 50 to 67) for vehicle control (P<0.001 for each treatment group vs. the vehicle-control group). Cure of the index lesion was accompanied by cure of all other lesions except in five patients, one in each of the paromomycin groups and three in the vehicle-control group. Mild-to-moderate application-site reactions were more frequent in the paromomycin groups than in the vehicle-control group. CONCLUSIONS: This trial provides evidence of the efficacy of paromomycin-gentamicin and paromomycin alone for ulcerative L. major disease. (Funded by the Department of the Army; ClinicalTrials.gov number, NCT00606580.).

Temporal dynamics and impact of climate factors on the incidence of zoonotic cutaneous leishmaniasis in central Tunisia.

BACKGROUND: Old world Zoonotic Cutaneous Leishmaniasis (ZCL) is a vector-borne human disease caused by Leishmania major, a unicellular eukaryotic parasite transmitted by pool blood-feeding sand flies mainly to wild rodents, such as Psammomys obesus. The human beings who share the rodent and sand fly habitats can be subverted as both sand fly blood resource. ZCL is endemic in the Middle East, Central Asia, Subsaharan and North Africa. Like other vector-borne diseases, the incidence of ZCL displayed by humans varies with environmental and climate factors. However, so far no study has addressed the temporal dynamics or the impact of climate factors on the ZCL risk. PRINCIPAL FINDINGS: Seasonality during the same epidemiologic year and interval between ZCL epidemics ranging from 4 to 7 years were demonstrated. Models showed that ZCL incidence is raising i) by 1.8% (95% confidence intervals CI:0.0-3.6%) when there is 1 mm increase in the rainfall lagged by 12 to 14 months ii) by 5.0% (95% CI: 0.8-9.4%) when there is a 1% increase in humidity from July to September in the same epidemiologic year. CONCLUSION/SIGNIFICANCE: Higher rainfall is expected to result in increased density of chenopods, a halophytic plant that constitutes the exclusive food of Psammomys obesus. Consequently, following a high density of Psammomys obesus, the pool of Leishmania major transmissible from the rodents to blood-feeding female sand flies could lead to a higher probability of transmission to humans over the next season. These findings provide the evidence that ZCL is highly influenced by climate factors that could affect both Psammomys obesus and the sand fly population densities.

Leishmania major infection among Psammomys obesus and Meriones shawi: reservoirs of zoonotic cutaneous leishmaniasis in Sidi Bouzid(central Tunisia).

A study was undertaken between November 2008 and March 2010, in the focus of cutaneous leishmaniasis of Central Tunisia, to evaluate the role of Psammomys obesus (n=472) and Meriones shawi (n=167) as reservoir hosts for Leishmania major infection. Prevalence of L. major infection was 7% versus 5% for culture (p=not signifiant [NS]), 19% versus 16% for direct examination of smears (p=NS), and 20% versus 33% (p=NS) for Indirect Fluorescent Antibody Test among P. obesus and M. shawi, respectively. The peak of this infection was in winter and autumn and increased steadily with age for the both species of rodents. The clinical examination showed that depilation, hyper-pigmentation, ignition, and severe edema of the higher edge of the ears were the most frequent signs observed in the study sample (all signs combined: 47% for P. obesus versus 43% for M. shawi; p=NS). However, the lesions were bilateral and seem to be more destructive among M. shawi compared with P. obesus. Asymptomatic infection was ~40% for both rodents. This study demonstrated that M. shawi plays an important role in the transmission and the emergence of Leishmania major cutaneous leishmaniasis in Tunisia.

First report of natural infection of least weasel (Mustela nivalis Linnaeus, 1776) with Leishmania major in Tunisia.

Zoonotic cutaneous leishmaniasis, caused by Leishmania major (L. major), is endemic in Tunisia. Several rodents have been identified as reservoir hosts of parasites. This study reports, for the first time, the natural infection with L. major zymodeme MON-25 in a specimen of least weasel: Mustela nivalis Linnaeus, 1776 (M. nivalis) collected in Sidi Bouzid. This finding justifies further research on larger samples of this animal to verify its role as a potential reservoir host for cutaneous leishmaniasis in Tunisia.