Micro-costing from healthcare professional's perspective and acceptability of cutaneous leishmaniasis diagnostic tools in Morocco: A mixed-methods study.

In Morocco, cutaneous leishmaniasis (CL) represents a concern with three causative parasite species. Despite this, rapid diagnostic test (RDT) for CL is not part of the national control strategy. This study evaluates the acceptability and micro-costing of the CL Detect Rapid Test by Inbios International. The study was conducted from June 2019 to January 2020 and included 46 healthcare professionals from 40 primary healthcare centers and district labs. Data was collected by self-administered questionnaires and interviews and analysed using NVivo, Jamovi, and Python to generate a predictive model and sensitivity analysis by calculating the average Cost-Benefit Ratio for compared CL diagnostic scenarios. The exchange rate is 1 USD = 9.6 MAD (Moroccan Dirham) in November 2019. The CL-RDT received notable acceptance for its user-friendliness and time efficiency compared to traditional microscopy. Micro-costing data revealed that the average unit cost for microscopy is 15 MAD [7-31], whereas 75 MAD [52-131] for CL-RDT. Altogether, the diagnostic cost for microscopy is 115 MAD±4, marginally higher than the 102 MAD±2 for CL-RDT (p = 0,05). Sensitivity analysis identified the most cost-benefit scenarios based on a Cost-Benefit Ratio (CBR). The optimal approach involves using CL-RDT once at a primary healthcare centre (PHC) (CBR = 1.4), especially if the unitary cost is below 79 MAD. The second-best option is using CL-RDT once at a laboratory (CBR = 1.0), which is advantageous if priced under 54 MAD. However, using CL-RDT twice for the same lesion had a less favourable CBR of 0.6 and was only beneficial if priced below 09 MAD. The reference scenario was a single CL-RDT at the PHC followed by microscopy at a laboratory. In conclusion, the forthcoming CL-RDT, expected to feature enhanced sensitivity, is advocated for deployment in resource-limited endemic areas.

The provider's checklist to improve pregnant women coverage by intermittent preventive malaria treatment in Mali: a pilot implementation study.

BACKGROUND: Intermittent preventive treatment of malaria in pregnancy (IPTp) is a comprehensive treatment protocol of anti-malarial drugs administered to pregnant women to prevent malaria, started at the fourth pregnancy month, with at least three doses of sulfadoxine-pyrimethamine (SP), taken as directly observed treatment (DOT) every 30 days at intervals until childbirth, in combination with other preventive measures. This paper introduces feasibility and adoption concepts as implementation research outcomes (IRO), allowing after a defined intervention, to assess the coverage improvement by IPTp for women attending a reference district hospital in Mali. Specifically, the purpose is to evaluate the feasibility of a reminder tool (provider checklist) to enhance pregnant women's adoption of information about IPTp-SP uptake as immediate and sustained women practices. METHODS: The implementation strategy used a reminder checklist about malaria knowledge and the recommended preventive tools. Then, the checklist feasibility was assessed during routine practices with the adoption-level about pregnant women' knowledge. Quantitative data were collected through a questionnaire distributed to a non-probability purposive sampling targeting 200 pregnant women divided into two groups before and after the checklist intervention. In contrast, the qualitative data were based on in-depth face-to-face gynaecologists' interviews. RESULTS: Both the IROs (feasibility and adoption) were satisfactory. The gynaecologists agreed to the use of this checklist during routine practice with a recommendation to generalize it to other health providers. After a gynaecologist visit, a significant increase of the adoption-level about prior knowledge and preventive tools was noticed. A total of 83% of participants were not knowledgeable about malaria disease before checklist use versus 15% after. Similarly, coverage of women's SP DOT rose from 0 to 59% after introducing the checklist and the IPTp-SP uptake after the visit was highly significant in the second group. The latter reached 95% of pregnant women with 4-8 months' gestational age, that mostly respected all SP future visits as theoretically scheduled. CONCLUSIONS: Generalizing such a checklist reminder will improve women's knowledge about malaria prevention.

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.

Accuracy of a Rapid Diagnostic Test Based on Antigen Detection for the Diagnosis of Cutaneous Leishmaniasis in Patients with Suggestive Skin Lesions in Morocco.

In rural areas in Morocco, diagnosing cutaneous leishmaniasis (CL) can be challenging. We evaluated the accuracy of a rapid diagnostic test (RDT) based on antigen detection, CL Detect Rapid Test™ (Inbios International Inc., Seattle, WA), in this setting. We consecutively recruited patients with new skin ulcers in nine primary health centers. We took a dental broach sample for the RDT and two other tissue samples by scraping the border and center of the lesion with a scalpel and smearing it on a slide. We duplicated each smear by pressing a clean slide against it and processed the slides by microscopy, polymerase chain reaction (PCR) internal transcribed spacer 1, and kDNA minicircle PCR. In a subgroup with positive PCR, the Leishmania species was identified using PCR-restriction fragment length polymorphism and PCR-sequencing of hsp70 genes. A participant with positive microscopy and/or PCR was considered a confirmed CL case. We computed sensitivity (Se) and specificity (Sp) of the RDT compared with this reference standard (ClinicalTrials.gov registration: NCT02979002). Between December 2016 and July 2017, we included 219 patients, 50% of them were under 18 years old. Rapid diagnostic test Se was 68% [95% confidence interval (CI): 61-74], Sp 94% [95% CI: 91-97], positive predictive value 95% [95% CI: 92-98], and negative predictive value 64% [95% CI: 58-70]. Despite its low Se, this novel RDT is a useful addition to clinical management of CL in Morocco, especially in isolated localities. Rapid diagnostic test-positive lesions can be treated as CL; but when RDT negative, microscopy should be done in a second step. The Se of the RDT can probably be optimized by improving the sampling procedure.

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.

Psychosocial burden of localised cutaneous Leishmaniasis: a scoping review.

BACKGROUND: Cutaneous Leishmaniasis (CL) is a parasitic skin disease, linked to poverty, and belonging to the group of Neglected Tropical Diseases. Depending on the severity, the type of lesions or scars, and the context, CL can lead to self- and social stigma influencing the quality of life and psychological well-being of the patient. This dimension is, however, little documented for the most common, localized form of cutaneous leishmaniasis (LCL). We aimed to describe the current knowledge on the psychological burden and the stigma related to LCL. METHODS: The population of interest for this scoping review are patients or their relatives with localized LCL or related scars. We searched the electronic databases PubMed, Web of Knowledge, PsycINFO, POPLINE, Cochrane Library, Science Direct, Global Health, and LILACS, for articles written in Arabic, English, French, Dutch, Portuguese, or Spanish, and published until the end of August 2017. RESULTS: From 2485 initial records, 15 papers met our inclusion criteria. Dermatology life quality index was the most frequent used scale to assess LCL psychological impact in quantitative studies. Six qualitative studies used individual interviews and/or focus groups discussions to explore the psychological and/or the social burden of this disease. Quantitative assessments using standard scales as well as qualitative research asserts that LCL is a source of psychological suffering, stigmatization, and decreased quality of life (QoL). CONCLUSION: Most studies showed that LCL has a significant negative effect on the QoL and mental health. However, the fact that the psychosocial burden generated by LCL is time-dependent makes it hard to measure. We recommend to develop a more specific and validated assessment scale to appreciate the full burden of this disease and enhance comparability of findings.

"The mosquitoes that destroy your face". Social impact of Cutaneous Leishmaniasis in South-eastern Morocco, A qualitative study.

OBJECTIVE: To document the psychosocial burden of Cutaneous Leishmaniasis (CL) in rural communities in Southeastern Morocco. METHOD: Between March and April 2015, we conducted qualitative research in communities exposed to Leishmania major or L. tropica in Errachidia and Tinghir provinces. Twenty-eight focus groups discussions (FGDs) were realized, with a stratification by gender and tradition of medicine (users of folk versus professional medicine). Data were analyzed using content analysis. RESULTS: This rural population most exposed to CL in Morocco lacks access to health care in general and clearly points out there are other major public health issues that need to be resolved. Nonetheless, respondents consider the impact of CL lesions and scars as important and similar to that of burn scar tissue. Young women with CL scars in the face are stigmatized and will often be rejected for marriage in these communities. People usually try a long list of folk remedies on the active lesions, but none was felt adequate. There was a clear demand for better treatment as well as for treatment of the scars. CONCLUSIONS: The psycho-social impact of CL due to L.major and L.tropica is substantial, especially for young single women with facial scars. These generate social and self-stigma and diminish their marriage prospects. CL is well known, but not considered as a major health priority by these poor rural communities in South-eastern Morocco where gender discrimination is still an issue and access to basic health care is as neglected as CL. Early CL diagnosis and new treatment options with better skin outcomes are urgently needed.

Psychosocial impact of scars due to cutaneous leishmaniasis on high school students in Errachidia province, Morocco.

BACKGROUND: In Morocco, cutaneous leishmaniasis (CL) is usually known to be a slowly healing localized skin disease, but in some cases, it can lead to mutilating scars. The outbreak of CL due to Leishmania major in the Errachidia province in southeastern Morocco between 2008 and 2010 left many adolescents with permanent scar tissue on the face or other exposed body parts. We studied the psychosocial impact of CL on these young people. METHODS: In 2015 we conducted a cross-sectional survey among high-school students living in boarding schools in two CL-endemic areas of Errachidia: Rissani and Tinejdad. A self-administered questionnaire elicited responses about general knowledge of CL and related scars. An open-ended question focused on the possible psychosocial effects associated with these scars. The quantitative data were analyzed with Epi Info™ and the text data with NVivo software. RESULTS: Almost 20% of 448 respondents reported they had experienced a CL lesion and 87% said it could possibly or definitely lead to psychological consequences. The text analysis showed that girls more often than boys expanded on the negative psychological effects of CL. The students considered CL as "dangerous", "serious", and "deathly", and said it sometimes led to extreme suicidal ideations. CONCLUSIONS: The burden of CL in this age group is not negligible. The indelible CL scars lead to self-stigma and social stigma, and the emergence of negative psychological effects in this age group. While some students accepted their CL scars and related suffering as their "destiny", others were eagerly demanding protective measures against CL and treatment for the scars.

Control of cutaneous leishmaniasis caused by Leishmania major in south-eastern Morocco.

OBJECTIVE: The incidence of cutaneous leishmaniasis (CL) caused by Leishmania major has increased in Morocco over the last decade, prompting the Ministry of Health to take intersectoral response measures including vector and reservoir control. The aim of this article was to describe the CL outbreak response measures taken in the province of Errachidia, where the reservoir of L. major, a sand rat (Meriones shawi), was targeted using strychnine-poisoned wheat baits from 2010 to 2012. METHOD: We analysed routine surveillance data and other information using the data of the CL control programme. RESULTS: We present data on the evolution and the extension of CL in this province as well as the epidemiological profile of the disease. Between 2004 and 2013, 7099 cases of CL were recorded in Errachidia Province, gradually affecting all districts. Our results demonstrate that more women were affected than men and that all age groups were represented. CONCLUSION: Errachidia Province was the epicentre of the recent CL outbreak in Morocco. A notable decline in incidence rates was observed after 2011. The outbreak control measures may have contributed to this decline, as well as climatic trends or progressing herd immunity.

Fee exemption for caesarean section in Morocco.

Financial barriers are an important obstacle for access to emergency obstetric care and a contributing factor to too slow a reduction in the level of maternal mortality. In Morocco, in 2009, a fee exemption policy for delivery and caesarean section was implemented in public maternity hospitals. As in most countries where a fee exemption policy has been implemented, fee exemption is considered synonym to free care. However, other direct costs may subsist. The objective of this study was to get an estimate of the actual cost of caesarean sections from the patients' perspective.This study was carried out in April 2010 in the three public hospitals in Fez. We carried out semi-structured interviews among a sample of 100 women who gave birth by caesarian section in the public hospitals in Fez. The results showed that households paid between US$169 (95% Confidence Interval (CI): 153, 185) at the provincial and regional hospitals, and US$291 (95% CI: 224-359) at the university hospital (UH) where the fee exemption was not applied. The direct cost of a caesarean was mainly influenced by the price of the drugs the families bought, the invoice paid at UH, and the transport. Finally, although the fee exemption policy for caesareans has probably reduced the total cost for households who did not have access to a poverty card, it has not led to 'truly' free caesarean deliveries.