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Evaluation of rapid diagnostic test prototypes detecting Wb123 antibodies in populations with Loa loa

This is a cross-reactivity evaluation of rapid tests detecting Wb123 antibodies. The test should perform similarly in sub-populations of individuals who are positive and negative for other filarial diseases, most importantly Loa loa. This field evaluation will determine the specificity of the tests in two separate populations, those positive and negative for Loa loa, and will be used to inform the product design and the product insert. This evaluation will recruit adults and children from regions that are known to have Loa loa in Cameroon.

 The study’s principal objective is to determine test specificity in individuals who are positive and negative for the filarial worm Loa loa. Secondary objectives are to determine the test specificity in individuals who are positive and negative for Mansonella perstans, and identify failure modes and failure rates of the rapid tests under surveillance conditions.

Countries: Cameroon

Feasibility, acceptability and cost implications of utilizing the SD BIOLINE Onchocerciasis IgG4 rapid test for onchocerciasis surveillance activities in Senegal

The demonstration study of the SD BIOLINE Onchocerciasis IgG4 rapid test aims to provide operational research data on the use and implementation of the test. The performance of the SD BIOLINE Onchocerciasis IgG4 rapid test has been verified in both reference laboratories as well as in controlled field settings. PATH and partners will explore the feasibility of incorporating the test into multiple sites in sub-Saharan Africa, with Senegal as a pilot country.

 We aim to demonstrate the acceptability and feasibility of the SD BIOLINE Onchocerciasis IgG4 test in the Senegal Onchocerciasis Control Programme surveillance activities relative to the diagnostic and collection tools currently used. 

Countries: Senegal
Diseases: Onchocerciasis

Evaluation of the Short Term Impact of MDA on Prevalence and Intensity

The purpose of this study is to determine differences between cure rates vs re-infection levels.  The fundamental question is to see what the prevalence and intensity are before MDA, and then, see what those are 7 to 8 weeks after MDA.  Since there are villages that continue to have high prevalence from year to year, we will determine if this primarily represents reinfection occurring since the last annual MDA or if it is related more to treatment efficacy.

Countries:
Diseases: Schistosomiasis

Persistent Hot Spots for Schistosoma mansoni Transmission in Western Kenya

A selected number of 5 villages near Lake Victoria shown to maintain very high levels of infection with S. mansoni following at least three rounds of annual praziquantel chemotherapy will be compared with 5 villages where infection rates have been much more responsive to similar levels of treatment, with respect to the following general considerations and questions:

1) What is the general situation for each village with respect to proximity of water bodies where intensive human contact occurs?

2) For each village, what is the role of each major habitat in transmission, as assessed by three separate techniques: water filtration; use of sentinel mice; and standard snail survey techniques?                                                                                                                                                                                                                                                                    

 

Countries: Kenya
Diseases: Schistosomiasis

Stigma Assessment and Reduction of Impact (SARI) Project

How effective are the following stigma reduction interventions when implemented in pairs to decrease leprosy-related stigma: 1) counselling and empowerment, 2) socio economic development, and 3) contact between community and people affected?

Countries: Indonesia

Molecular Xenomonitoring for Lymphatic Filariasis in Bangladesh

Mass drug administration (MDA) programs have dramatically reduced lymphatic filariasis (LF) incidence in many areas around the globe, including Bangladesh. Post-treatment surveillance activities as recommended by WHO include repeated transmission assessment surveys (TAS) among children and ongoing surveillance to detect new foci of transmission and collect data on infection trends in the general population. The contribution of molecular xenomonitoring (MX, or detection of filarial DNA in mosquitoes) to confirm the interruption of transmission during the post-treatment surveillance phase has not been well defined. There is also a need to better understand the relationship between the prevalence of W. bancrofti DNA in mosquitoes and infection in humans.

Countries: Bangladesh

An evaluation of the effectiveness of the trachoma surveillance strategy and the use of alternative diagnostic indicators to validate the elimination of blinding trachoma in Ghana

To determine if PCR or serology techniques are better than TF for assessing Trachoma prevalence during the surveillance phase of Trachoma Elimination Programs.

Countries: Ghana
Diseases: Trachoma | Yaws

Exploring alternative indicators for trachoma endpoint decision-making (Uganda)

Analyze the relationships between the prevalence of the clinical sign follicular trachoma (TF) and the prevalence of infection and antibody to determine whether it may be appropriate to consider one or more alternative indicators for deciding whether trachoma programs can stop MDA.

Countries: Uganda
Diseases: Trachoma

Exploring alternative indicators for trachoma endpoint decision-making (Tanzania)

Analyze the relationships between the prevalence of the clinical sign follicular trachoma (TF) and the prevalence of infection and antibody to determine whether it may be appropriate to consider one or more alternative indicators for deciding whether trachoma programs can stop MDA.

Countries: Tanzania
Diseases: Trachoma

Exploring alternative indicators for trachoma endpoint decision-making (Malawi)

Analyze the relationships between the prevalence of the clinical sign follicular trachoma (TF) and the prevalence of infection and antibody to determine whether it may be appropriate to consider one or more alternative indicators for deciding whether trachoma programs can stop MDA.

Countries: Malawi
Diseases: Trachoma

Piloting the Supervisor's Coverage Tool in Cross River State, Nigeria

To pilot a rapid coverage supervision tool (now known as the Supervisor's Coverage Tool) that can be used to determine if the supervision areas under investigation are likely to have exceeded the WHO threshold for coverage and to serve as an in-process monitoring tool for supervising the MDA distribution. Report to WHO M&E working group; potential for inclusion in future WHO program assessment guidelines.

The Supervisor’s Coverage Tool (SCT) is a quick, simple, and inexpensive monitoring tool that can be used to assess preventive chemotherapy coverage of a mass drug administration (MDA). During the development and optimization process of the tool, the SCT was piloted in communities in Nigeria and Ethiopia. The pilot study in Cross River State, Nigeria, included seven first-level Supervision Areas (SA), which corresponded to villages in four Local Government Areas (LGAs). Drug coverage was assessed for ivermectin and albendazole in four SAs and only Ivermectin in three SAs. 

Findings and lessons learned:

-          The main reasons for not swallowing medicines were community drug distributor (CDD) not showing up, respondent being away at time of drug distribution or not collecting drug from a fixed point of distribution, fear of side effects, drug supply running out, recent migration, and lack of awareness about drug distribution.

-          The SCT permitted LGA coordinators to supervise the drug distribution systematically, which allowed them to find out that in most parts of one LGA treatment was suspended despite the CDD claiming the completion of treatment in the area.

-          Some treatment registers did not include all people living in the SA, therefore some households were not included in the CDDs treatment boundaries. On the other hand, some LGAs had very good treatment registers, proper documentation of treatment from CDDs, and their community also commended them during village gatherings expressing their gratitude.

-          All CDDs were making remarkable effort with little or no reward. Unlike previous monitoring visits where supervisors have to field numerous complaints around incentives, because the SCT gave supervisors an objective evaluation of their work, many CDDs did not feel justified in complaining about incentives.

-          Overall, the SCT was deemed feasible to implement at the supervisory area and the information generated led to programmatic action to improve treatment coverage.

Countries: Nigeria

STH TAS Surveys

Pilot Assessment of Soil-Transmitted Helminthiasis in the Context of Transmission Assessment Surveys for Lymphatic Filariasis in Benin and Tonga. A transmission assessment survey (TAS) is recommended to determine if MDA for LF can be stopped within an evaluation unit (EU) after at least five rounds of annual treatment. The TAS also provides an opportunity to simultaneously assess the impact of these MDAs on STH and to determine the frequency of school-based MDA for STH after community-wide MDA is no longer needed for LF.

Countries: Benin | Tonga

Achieving LF Elimination in the Pacific Island Countries

Organize existing data for preparation of LF elimination dossiers based on the PacELF programs.

Countries: Japan | Australia

A comparison study of ICT cards and the new Filariasis Test Strip (FTS)

Comparison of ICT and FST.

Study Findings:

  • A total of 2,956 samples were investigated simultaneously via ICT cards and FTS - representative of the population of six health districts that had conducted five rounds of MDA for lymphatic filariasis.

  • The multi-country studies on the same topic led to the endorsement by WHO for the FTS as an approved diagnostic tool.
Countries: Niger | Liberia

Evaluating treatment coverage for trachoma in two districts in Malawi

To measure the feasibility of using a PPES sampling approach with segmentation within each EA to measure coverage. In addition to collecting data on coverage the team also used mobile devices to collect data on time and distance traveled as well as the availability of village registers. These data contribute to the larger coverage evaluation study taking place in multiple countries.

Preliminary Findings and Lessons Learned

Coverage surveys are an important tool for programs to evaluate their reporting systems and to determine whether effective MDA coverage has been achieved. However, for various reasons coverage surveys are seldom implemented.  Some key challenges are: perceived technical difficulty, lack of resources, and lack of standardized guidance on how to conduct coverage surveys.  This protocol seeks to pilot a newly refined probability sampling with segmentation approach in 2 districts in Malawi.  The two surveys found that the survey coverage was above the WHO target thresholds for Zithromax. Furthermore, the team found the survey methodology to be clear and feasible to implement.  This adds further evidence to the previous studies that support the use of the segmentation approach for coverage surveys across all 5 PC NTDs.

Countries: Malawi
Diseases: Trachoma

Post-MDA LF Surveillance Modeling: Developing Stratified Risk Maps

The purpose of this project is to create maps that utilize LF risk and prevalence data to predict risk of recrudescence, and to stratify this risk into 3-4 distinct groups. Such maps could subsequently be used to design and simulate the performance of different surveillance strategies. 

Preliminary study findings:

  • The intensity of transmission was quantified by the basic reproductive number (R0).

  • A map of predicted prevalence of microfilaraemia, developed through Bayesian geostatistical modelling, was linked to mathematical models of the transmission dynamics of lymphatic filariasis.

  • The models predict a marked geographical heterogeneity in the intensity of lymphatic filariasis transmission in Sub-Saharan Africa.

  • Further control efforts may be required in areas of higher intensity of transmission.

  • Conversely, interruption of transmission might be achieved earlier in areas of low intensity of transmission.

  • The results suggest that intensity of transmission at baseline (R0) and bednet use are the best indicators for the level of surveillance required sub-nationally post-MDA.

Analysis of LF-Antibody Responses Following MDA in Kenya

To determine the current status of LF using a combination of seroepidemiological tools to determine prevalence of circulating filarial antigen (CFA) and antifilarial antibodies.

Preliminary study findings:

  • 2,976 individuals (age: 2 to 100 years) were tested for circulating filariail antigen using the immunochromatographic (ICT) test during daytime visits. Night-time blood samples to detect microfilariae (MF) were requested from those who tested positive via the ICT test.
  • Out of the 38 persons found to be positive for LF infection by ICT test, 33 provided a night-time blood sample for examination of MF. Overall, nine individuals were found to be MF positive, with the highest prevalence in Ndau Island.
  • The current study suggests that LF transmission may be absent in Taita-Taveta and Tana River counties in coastal Kenya and therefore transmission assessment surveys (TAS) should be considered with a view to stopping MDA. By contrast, evidence for ongoing transmission in Kwale, Kilifi and Lamu counties indicates the need for further MDA rounds in these counties.
  • Additionally, the study demonstrated the feasibility of conducting integrated serosurveillance of several infectious diseases of public health interest, as well as levels of seroprotection against vaccine preventable diseases. The findings of the current study underscore the added value of using multiplex antibody measurements to guide and monitor LF elimination efforts.
Countries: Kenya

Correlation of Xenomonitoring and LF-Antibody Responses as Measures of Transmission in American Samoa

Determine the utility of xenomonitoring and serological assessments for the detection of residual transmission

Countries: American Samoa

Integrated Surveillance for Onchocerciasis and Lymphatic Filariasis

Innovative approach to exploit ongoing STH- SCH survey to conduct integrated surveillance for LF and oncho that will serve as a model for other programs

Countries: Togo

Evaluation of Schistosomiasis RDT (CCA) in DRC

To complete mapping of NTDs in AFRO and support transitioning of new diagnostics tools into program use.

Countries: Dem. Rep. of Congo
Diseases: Schistosomiasis

Ab assessment by multiplex for LF, Trachoma, and Yaws

Determine the age prevalence of LF antibody following MDA to inform surveillance strategies. Yaws and trachoma testing will also occur during the survey.

Countries: Fiji

Defining the Profile of LF Antibody Reactivity following MDA

Determine age-specific prevalence of LF Antibody following MDA to inform surveillance strategies.

Countries: French Polynesia

Rapid Integrated Mapping of Schistosomiasis and Soil-Transmitted Helminthiasis Using POC-CCA and Kato-Katz Tests

Complete mapping of NTDs in AFRO. Support transitioning of new diagnostics tools into program use. (Refer to 23.1, 23.2, 23.3, 23.4, 23.5, 23.6, 23.7, 23.8, 23.9, 23.10.)

Diseases: Schistosomiasis

Comparison of FTS antigen and Wb123 ELISA in a co-endemic LF and Loiasis area (Or Integrated lymphatic filariasis and Loiasis mapping)

Compare lymphatic filariasis FTS antigen prevalence to the Wb123 antibody prevalence in an area co-endemic with Loa-loa. Refine LF prevalence with FTS and provide evidence for MDA intervention by excluding areas where prevalence of ICT card is due to Loa loa cross reaction; 2) Provide additional data to address the influence of Loa loa cross-reaction and the specificity of antigen rapid test positive result alone to identify ongoing LF transmission in areas co-endemic for LF and Loiasis.

The Impact of WASH on Re-infection with STH

Study the impact of WASH on Trachoma by adding an STH intervention and post-treatment evaluation. WASH intervention and control communities will be treated with albendazole and STH burden will be assessed pre-treatment and at annual intervals thereafter.

Countries: Ethiopia

ICT-FST Comparison in Low Prevalence setting of Haiti

Comparison of ICT, FST and Antibody tests in low-prevalence settings.

The multi-country studies on the same topic led to the endorsement by WHO for the FTS as an approved diagnostic tool.

Countries: Haiti

Systematic Comparison of MF and Ab Prevalence by Age, Post-MDA

To validate the Brugia antibody tests as a tool for stopping LF MDA.

Countries: Indonesia

Trachoma Post- MDA Surveillance Project

To validate thresholds for stopping MDA and improve confidence that elimination goals have been achieved through post-MDA surveillance.

Countries: Nepal
Diseases: Trachoma

TAS survey - ICT-FTS Comparison study: A multi-center study comparing the ICT test and the new Filariasis Test Strip (FTS) tests in low prevalence settings of two Albay districts, Philippines

A comparison study of ICT cards and the new Filariasis Test Strip in Albay district, Philippines. Make recommendations for the new LF diagnostic test for the broader community.

Study Findings:

  • A total of 60 primary schools were surveyed using ICT tests, while a total of 46 primary schools were surveyed using FTS. In some instances, additional blood was not collected for FTS due to parental refusal.

  • Of the 2,944 children examined via ICT, 1 (0.034%) tested positive. No FTS was done on this child.

  • Of the 1,885 children examined via FTS, 1 (0.05%) tested positive. That same child tested negative via ICT and via repeat FTS.

  • FTS resulted in 57 invalid results due to: 1) test strips having no reaction, 2) detached sample pad on test strips, or 3) blood failing to travel upward after being absorbed by the test strips. In addition, some FTS foil pouches were empty.

  • Wb123 antibody levels appear to be relatively low among younger age groups and increase with age.

  • There was little observed change in antibody levels from Phase 1 (Oct 2014) to Phase 2 (Feb 2016).
Countries: Philippines

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