Evaluation of the diagnostic performance and operational characteristics of four rapid immunochromatographic syphilis tests in Burkina Faso

Background and objective: Little information is available on the rapid diagnostic testing for syphilis in Burkina Faso. The objectives of the study were (i) to assess the sensitivity and specificity of four on site rapid tests in comparison with Treponema pallidum haemagglutination assay (TPHA) as a gold standard and (ii) to evaluate the operational characteristics of those tests among health workers in a maternity unit.Methods: Four rapid syphilis tests commercially available in Burkina Faso were evaluated using archived serum samples and Treponema pallidum hemagglutination assay (TPHA) as the gold standard. Blood samples were collected between November 2011 and June 2012 from blood donors at the Regional Blood Transfusion Center of Ouagadougou. The sensitivity and specificity of the tests were calculated. Evaluation of operational characteristics such as clarity of pamphlet, complexity of technique, duration, was conducted in a first-level healthcare center with health workers in maternity unit.Results: Alere DetermineTM Syphilis was the most sensitive of the four rapid syphilis tests evaluated. It was followed by SD Bioline Syphilis 3.0, Cypress Diagnostics Syphilis Quick test and Accu-Tell ® Rapid Anti-TP, which was the least sensitive. The four tests demonstrated a good diagnostic specificity for syphilis (95–98%), and healthcare workers found them easy to use.Conclusions: The study allowed confirming the good performance of three of four rapid syphilis tests in Burkina Faso. More research will be conducted to assess the feasibility of introducing selected rapid tests for syphilis in antenatal care services.Keywords: syphilis, rapid test, performance, Burkina Fas

Rifampicin and clarithromycin (extended release) versus rifampicin and streptomycin for limited Buruli ulcer lesions: a randomised, open-label, non-inferiority phase 3 trial.

BACKGROUND: Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifampicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions. METHODS: We did an open-label, non-inferiority, randomised (1:1 with blocks of six), multicentre, phase 3 clinical trial comparing fully oral RC8 with RS8 in patients with early, limited Buruli ulcer lesions. There were four trial sites in hospitals in Ghana (Agogo, Tepa, Nkawie, Dunkwa) and one in Benin (Pobè). Participants were included if they were aged 5 years or older and had typical Buruli ulcer with no more than one lesion (caterories I and II) no larger than 10 cm in diameter. The trial was open label, and neither the investigators who took measurements of the lesions nor the attending doctors were masked to treatment assignment. The primary clinical endpoint was lesion healing (ie, full epithelialisation or stable scar) without recurrence at 52 weeks after start of antimicrobial therapy. The primary endpoint and safety were assessed in the intention-to-treat population. A sample size of 332 participants was calculated to detect inferiority of RC8 by a margin of 12%. This study was registered with ClinicalTrials.gov, NCT01659437. FINDINGS: Between Jan 1, 2013, and Dec 31, 2017, participants were recruited to the trial. We stopped recruitment after 310 participants. Median age of participants was 14 years (IQR 10-29) and 153 (52%) were female. 297 patients had PCR-confirmed Buruli ulcer; 151 (51%) were assigned to RS8 treatment, and 146 (49%) received oral RC8 treatment. In the RS8 group, lesions healed in 144 (95%, 95% CI 91 to 98) of 151 patients, whereas lesions healed in 140 (96%, 91 to 99) of 146 patients in the RC8 group. The difference in proportion, -0·5% (-5·2 to 4·2), was not significantly greater than zero (p=0·59), showing that RC8 treatment is non-inferior to RS8 treatment for lesion healing at 52 weeks. Treatment-related adverse events were recorded in 20 (13%) patients receiving RS8 and in nine (7%) patients receiving RC8. Most adverse events were grade 1-2, but one (1%) patient receiving RS8 developed serious ototoxicity and ended treatment after 6 weeks. No patients needed surgical resection. Four patients (two in each study group) had skin grafts. INTERPRETATION: Fully oral RC8 regimen was non-inferior to RS8 for treatment of early, limited Buruli ulcer and was associated with fewer adverse events. Therefore, we propose that fully oral RC8 should be the preferred therapy for early, limited lesions of Buruli ulcer. FUNDING: WHO with additional support from MAP International, American Leprosy Missions, Fondation Raoul Follereau France, Buruli ulcer Groningen Foundation, Sanofi-Pasteur, and BuruliVac

Community intervention for child tuberculosis active contact investigation and management : study protocol for a parallel cluster randomized controlled trial

Background There are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings. Methods/design This multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or older (5–14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm. Discussion This study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings. Trial registration ClinicalTrials.gov NCT03832023. Registered on 6 February 201

Baseline mapping of neglected tropical diseases in Africa: the accelerated WHO/AFRO mapping project

Mapping is a prerequisite for effective implementation of interventions against neglected tropical diseases (NTDs). Before the accelerated World Health Organization (WHO)/Regional Office for Africa (AFRO) NTD Mapping Project was initiated in 2014, mapping efforts in many countries were frequently carried out in an ad hoc and nonstandardized fashion. In 2013, there were at least 2,200 different districts (of the 4,851 districts in the WHO African region) that still required mapping, and in many of these districts, more than one disease needed to be mapped. During its 3-year duration from January 2014 through the end of 2016, the project carried out mapping surveys for one or more NTDs in at least 2,500 districts in 37 African countries. At the end of 2016, most (90%) of the 4,851 districts had completed the WHO-required mapping surveys for the five targeted Preventive Chemotherapy (PC)-NTDs, and the impact of this accelerated WHO/AFRO NTD Mapping Project proved to be much greater than just the detailed mapping results themselves. Indeed, the AFRO Mapping Project dramatically energized and empowered national NTD programs, attracted donor support for expanding these programs, and developed both a robust NTD mapping database and data portal. By clarifying the prevalence and burden of NTDs, the project provided not only the metrics and technical framework for guiding and tracking program implementation and success but also the research opportunities for developing improved diagnostic and epidemiologic sampling tools for all 5 PC-NTDs-lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminthiasis, and trachoma

Feasibility of a randomized clinical trial evaluating a community intervention for household tuberculosis child contact management in Cameroon and Uganda

Background One of the main barriers of the management of household tuberculosis child contacts is the necessity for parents to bring healthy children to the facility. We assessed the feasibility of a community intervention for tuberculosis (TB) household child contact management and the conditions for its evaluation in a cluster randomized controlled trial in Cameroon and Uganda. Methods We assessed three dimensions of feasibility using a mixed method approach: (1) recruitment capability using retrospective aggregated data from facility registers; (2) acceptability of the intervention using focus group discussions with TB patients and in-depth interviews with healthcare providers and community leaders; and (3) adaptation, integration, and resources of the intervention in existing TB services using a survey and discussions with stakeholders. Results Reaching the sample size is feasible in all clusters in 15 months with the condition of regrouping 2 facilities in the same cluster in Uganda due to decentralization of TB services. Community health worker (CHW) selection and training and simplified tools for contact screening, tolerability, and adherence of preventive therapy were key elements for the implementation of the community intervention. Healthcare providers and patients found the intervention of child contact investigations and TB preventive treatment management in the household acceptable in both countries due to its benefits (competing priorities, transport cost) as compared to facility-based management. TB stigma was present, but not a barrier for the community intervention. Visit schedule and team conduct were identified as key facilitators for the intervention. Conclusions This study shows that evaluating a community intervention for TB child contact management in a cluster randomized trial is feasible in Cameroon and Uganda. Trial registration Clini calTr ials. gov NCT03832023. Registered on February 6th 2019

Phenotypic variability and correlation estimates for traits of Burkina Faso\u2019 sweet grain sorghum genotypes

Sweet grain sorghum [ Sorghum bicolor (L.) Moench] is a neglected crop mainly grown for its sweet grains in the pasty form. Although its taste is the main character of interest, knowledge of protein related content of the grain, especially when linked to its value for infant porridge appears equally important. The objective of this study was to evaluate the status of crude protein content of pasty grains and to determine genetic correlations between morphological and biochemical traits among sweet grain of sorghum genotypes in Burkina Faso. Eight sweet grain sorghum cultivars (BTO2, BZI1, KBZ4, PBO5, PGO3, SBR7, SPI2, STO4) were evaluated through 13 morphological and two biochemical variables. Crude protein content of these genotypes was also compared with the composition of two controls of sweet stalk sorghum (ETS) and ordinary grain sorghum or common sorghum (EBS). The analysis of variance revealed variability within sweet grain sorghum accessions, mainly on the biochemical traits (crude protein and water content) and two morphological traits (peduncle and panicle lengths), which discriminated significantly in the thresholds of 1 and 5%, respectively. In addition, sweet grain sorghum had low crude protein content compared to other types of sorghum, except, two genotypes of sweet grain sorghum (BZI1 and STO4) which recorded higher protein content compared to the common sorghum. An important and negative correlation was noted between sowing-flowering cycle and protein content.Le sorgho grains sucr\ue9s [ Sorghum bicolor (L.) Moench] est une culture n\ue9glig\ue9e produite essentiellement pour ses grains sucr\ue9s au stade p\ue2teux. Bien que la saveur sucr\ue9e du grain soit le principal caract\ue8re d\u2019int\ue9r\ueat, une connaissance de la teneur en prot\ue9ines totales du grain au stade p\ue2teux pourrait favoriser son utilisation pour impl\ue9menter les bouillies infantiles et contribuer \ue0 sa meilleure valorisation. La pr\ue9sente \ue9tude vise donc \ue0 d\ue9terminer la teneur en prot\ue9ines totales des grains au stade p\ue2teux du sorgho grains sucr\ue9s et \ue9tablir les corr\ue9lations g\ue9n\ue9tiques entre les caract\ue8res morphologiques et biochimiques. Ainsi, huit g\ue9notypes de sorgho grains sucr\ue9s (BTO2, BZI1, KBZ4, PBO5, PGO3, SBR7, SPI2, STO4) ont \ue9t\ue9 \ue9valu\ue9s \ue0 l\u2019aide de 13 caract\ue8res morphologiques et deux caract\ue8res biochimiques. La teneur en prot\ue9ines totales de ces g\ue9notypes a \ue9t\ue9 ensuite compar\ue9e \ue0 celle de deux t\ue9moins dont un sorgho \ue0 tige sucr\ue9e (ETS) et un sorgho ordinaire (ESB). L\u2019analyse de variance a r\ue9v\ue9l\ue9 une variabilit\ue9 au sein des cultivars de sorgho grains sucr\ue9s observ\ue9e surtout au niveau des traits biochimiques (teneur en prot\ue9ines totales des graines et teneur en eau des graines) et de deux traits morphologiques (longueur du p\ue9doncule et longueur de la panicule) qui ont significativement discrimin\ue9 les accessions aux seuils de 1 et 5%, respectivement. De plus, le sorgho grains sucr\ue9s a pr\ue9sent\ue9 une faible teneur en prot\ue9ines totales comparativement aux autres types de sorgho \ue0 l\u2019exception de deux g\ue9notypes (BZI1 et STO4) qui ont montr\ue9 une teneur en prot\ue9ines plus \ue9lev\ue9e que le sorgho ordinaire. Une forte corr\ue9lation significative et n\ue9gative a \ue9t\ue9 \ue9galement not\ue9e entre le cycle semis-floraison et la teneur en prot\ue9ines totales