World Health Organization (WHO)

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.

CCA Protocol: To know the sensitivity and specificity of POC CCA in the detection of urinary schistosomiasis, as compared to traditional diagnostic tools.

RQ1 - Reliability assessment: What is the intra- and inter-rater reliability of current qualitative F and novel quantitative hygiene metrics across study contexts?

RQ2 – Validity assessment: What is the validity of each metric of interest (i.e., quantitative hygiene and qualitative F metrics) with regard to recent personal hygiene practices and trachoma outcomes?

RQ3 – Utility assessment: What is the utility of each metric (i.e., qualitative and quantitative)?

RQ4 – Risk factor assessment: Do proxy facial and hand hygiene outcomes, as measured by the novel quantitative hygiene metric, represent risk factors of incident C. trachomatis infection?

Compare coverage evaluation methods to identify a method that is statistically rigorous and feasible for programs. This study will focus on assessing MDA coverage for lymphatic filariasis by comparing the cost, time and feasibility of the EPI approach (n=1768), LQAS design (n=95) and probability sampling alternatives (n=1768).

Primary 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 address the 1st and 3rd points by comparing the feasibility of three different coverage survey methods (EPI approach, LQAS, and segmentation).     This study was completed in 3 districts in Burkina Faso.  All 3 districts found that their survey coverage was above the WHO target threshold (65% for LF).  Furthermore, in all 3 cases the survey coverage validated (or nearly validated) the reported coverage. Taken together this suggests that the Burkina Faso program is working well.   The feasibility results found all 3 methods to be very similar with regards to time, cost and perceived difficulty.  Because only the segmentation approach results in a probability sample, this method was recommended by the M&E Working Group and ultimately approved by the STAG.  Since the approval, significant work has been underway to create guidelines for conducting coverage surveys for preventive chemotherapy.  An excel tool was created to improve the usability of the tool and online learning modules are currently in the works.

Compare coverage evaluation methods to identify a method that is statistically rigorous and feasible for programs. This study will focus on assessing MDA coverage for lymphatic filariasis by comparing the cost, time and feasibility of 3 different methods: the EPI approach (n=1768), LQAS design (n=95) and probability sampling alternatives (n=1768).

Primary 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 address the 1st and 3rd points by comparing the feasibility of three different coverage survey methods (EPI approach, LQAS, and segmentation).     This study was completed in 3 districts in Burkina Faso.  All 3 districts found that their survey coverage was above the WHO target threshold (65% for LF).  Furthermore, in all 3 cases the survey coverage validated (or nearly validated) the reported coverage. Taken together this suggests that the Burkina Faso program is working well.   The feasibility results found all 3 methods to be very similar with regards to time, cost and perceived difficulty.  Because only the segmentation approach results in a probability sample, this method was recommended by the M&E Working Group and ultimately approved by the STAG.  Since the approval, significant work has been underway to create guidelines for conducting coverage surveys for preventive chemotherapy.  An excel tool was created to improve the usability of the tool and online learning modules are currently in the works.

This study is designed as a proof-of-concept to test the feasibility and acceptability of a proposed intervention package outlined in a soon to be published WHO manual on NTDs and mental health. The primary output of this study is to adapt a model of intervention from the soon to be published WHO guide on Mental Health and NTDs. The team aims to achieve this output through:

• Screening 300 individuals for symptoms of depression and anxiety, refer where necessary, and sample 30 of those individuals for participation in qualitative interviews.
• Conducting peer-led focus group discussions (separate groups for leprosy and LF) to better understand the needs, priorities, and barriers related to affected individuals’ mental wellbeing and quality of life.
• Conducting a workshop with health leaders, community health workers, nurses, service users, family/caregivers, and experts to develop a feasible and applicable theory of change that aligns with WHO guidelines.
• Conducting in depth interviews with key stakeholders to assess the developed model’s feasibility and accessibility Conducting quantitative measures for feasibility and acceptability to assess the stepped-care approach model which involves: improved screening, referral, uptake of service, knowledge uptake following training, and an assessment of whether supervision was carried out. They also plan to triangulate health information data to determine uptake of services.
• Conducting follow-up FGDs with those 30 individuals after a one-month period to understand their experience with primary health center mental health services.

What is/are the most suitable indicator(s) for monitoring IDA treatment regimen against LF and for making IDA stopping decisions?

To assess the specificity of diagnostic tools in Loa co-endemic areas and to conduct a prospective assessment of the impact of ALB MDA and Vector control on malaria, LF and STH indicators.

Comparison of different diagnostic tools during onchocerciasis, lymphatic filariasis and Loa loa mapping and epidemiological assessments, including Ov16 ELISA, OV16 rapid diagnostic test (RDT) and skin snip test. (Refer to 065.1, 065.2, 065.3, 65.6 & 65.7.)

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.

To compare antigenemia results by ICT and FTS RDT, antibody responses to Wb123 and Ov 16 by ELISA , and Wb123/Ov16 Biplex RDT on LF sentinel sites.

Develop a program evaluation tool to permit program managers to effectively assess coverage and compliance. This study will focus on assessing MDA coverage for lymphatic filariasis by comparing the cost, time and feasibility of the EPI approach (n=480), LQAS design (n=95) and probability sampling alternatives (n=480).

Preliminary study findings:

• All three survey methods were feasible for the teams to implement and cost <$5,000.
• Preschool deworming coverage, provided through the community-based MDA, was <60%.
• The main reason for refusing the medication was that the child had recently been dewormed.
• Approximately 80% of preschool children surveyed received at least one dose of unprogrammed deworming in the past 12 months.
• The main sources of unprogrammed deworming were health centers, local pharmacies, and bodegas.

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

Demonstrate the utility of a new mapping strategy based on school cluster random sampling Using PPES. A secondary objective is to assess the value of laboratory-based antibody assays as confirmatory tests and additional diagnostic tools for measuring LF transmission. 

To analyze the relationships between the currently used indicator for impact assessments - prevalence of the clincial sign TF - and the prevalence of infection and antibody among 1-9 year old children in hyperendemic districts prior to mass drug administration

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.

Evaluate the current status of transmission of onchocerciasis in a hyperendemic area treated for many years and in a hypoendemic area treated for lymphatic filariasis for 5 years using the Ov16 ELISA and supplemented by entomology results from a previous study

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

To refine the use of multi-parallel quantitative real-time PCR (qPCR) for STH parasites. Those parasites included in this proposal are Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis and Trichuris trichiura. Collect parasites of all five species in Argentina.

Comparison of different diagnostic tools during onchocerciasis mapping, including Ov16 ELISA, OV16 rapid diagnostic test (RDT) and skin snip test.

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.

Comparison of ICT and FTS.

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

To assess the programmatic feasibility of and determine the most appropriate age group and sampling strategy for an oncho mapping survey for ivermectin-naïve areas

Follow-up LF TAS and comparison of ICT and Filariasis Strip Test in a post-MDA surveillance setting.

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

This study is piloting the Supervisor's Coverage Tool (formerly the Coverage Supervision Tool, or CST) approach that is meant to provide a platform for district- and sub-district-level supervisors to monitor the success of the last MDA. It is meant to be conducted at the sub-district level two weeks following MDA and provides a pass/fail result regarding whether the target coverage threshold was met. It is designed as a quick and inexpensive in-process monitoring tool for use by sub-national level NTD management teams/supervisors to help improve or maintain the success of future MDA rounds.

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

Assess Wb123 antibody responses in communities where LF transmission was interrupted without MDA.

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

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.

Assess the performance of LF and Oncho diagnostic tools after stopping LF MDA but continuing Oncho MDA.

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.

Demonstrate the utility of a new mapping strategy based on school cluster random sampling Using PPES. A secondary objective is to assess the value of laboratory-based antibody assays as confirmatory tests and additional diagnostic tools for measuring LF transmission. 

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.

To compare TAS-STH vs. a standalone STH survey in 5 schools surveying 250 kids. TAS-STH Community study will have 6-7 year olds while the STH survey focuses on 10-14 year olds.

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

To validate a new TAS-STH survery in a complex progammatic setting.