Country operational research priorities pending.
To determine the appropriate serologic threshold(s) to be used to initiate MDA for onchocerciasis
The question of how to conduct post-elimination surveillance is a high priority for the NTD community, given that most NTD programs scale back or shut down completely once elimination as a public health problem is achieved. Few solutions exist and this proposal provides an interesting and useful case study for surveillance moving forward. The study team plans to target 1708 pregnant women as a proxy for measuring LF resurgence in a post-elimination context. As a comparison group, they plan to conduct a prevalence survey of 427 households (1708 participants) in the same community to compare LF prevalence found in each methodology. Each participant at the health facility’s residence will be geo-referenced to understand the coverage area. They also plan to conduct interviews with patients and health workers, a time-motion study, and a cost analysis to assess the additional burden on health care workers and the health system. The study will occur in 14 facilities in one district of Malawi where LF was highly endemic prior to the launch of the program.
This project intends to assess the effectiveness of using the Community Directed Intervention (CDI) approach as a vehicle for delivery of mass drug administration (MDA) campaigns against targeted NTDs namely, schistosomiasis and soil-transmitted helminths (STH) such as Ascaris lumbricoides (roundworms), Trichuris trichiura (whip worms) and Ancylostoma sp. (hookworms) in selected districts of Malawi. The idea is to take advantage of the logistical setup, organizational strength and high degree of efficiency of the national NTD programme to improve delivery of the current MDA efforts to control selected and highly prioritized NTDs of schistosomiasis and STH and to enhance community ownership of the interventions in selected rural and remote communities by using the CDI approach. The primary research question is: Can the CDI approach be effectively used to deliver MDA to control NTDs at community level in rural Malawian districts?
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
A pilot study to identify meaningful and measurable targets for detecting the control of schistosomiasis-related morbidity in Africa. The overall study is designed to answer the following primary evaluation questions:
- What are the infection levels of Schistosoma mansoni and S. haematobium below which there is little, or no, detectable schistosomiasis-associated morbidity?
- What are the optimal morbidity markers for S. mansoni and S. haematobium?
- What are the optimal species-specific morbidity goals for which schistosomiasis control programs should be aiming?
Would the same programmatic decisions for Oncho Elimination Mapping be made based off of the Ov16 rapid diagnostic test results as compared to the Ov16 SD ELISA results?
Currently MDA is stopped when TF in children aged 1-9 years is below 5%. However, the relationship between TF, presence of infection and antibody has not been studied in a sufficient number of settings to enable predictions of outcome to be confidently made based on baseline prevalence, intervention coverage, and the prevalence of disease and infection at the time of impact survey. There are several districts in Malawi with TF prevalence between 5 and 9.9% which are eligible for one year of interventions, including a single round of MDA. This study will add important data to be used to model outcomes of interventions conducted by trachoma elimination programs, and in particular, help develop operational guidelines for stopping MDA.
The DeWorm3 Project is a series of hybrid trials testing the feasibility of interrupting the transmission of soil transmitted helminths (STH), while conducting implementation science research that contextualizes clinical research findings and provides guidance on opportunities to optimize delivery of STH interventions.
The purpose of DeWorm3 implementation science studies is to ensure rapid and efficient translation of evidence into practice. Research methods include: (1) stakeholder mapping and network analysis, (2) qualitative research, (3) structural readiness surveys, (4) process mapping, and (5) economic evaluation (costing and cost-effectiveness).
Implementation science research aims include:
1)To systematically identify stakeholders influencing standard of care targeted and community-wide MDA and map their potential role and involvement in scale-up of community-wide MDA for STH.
2)To identify implementation-related barriers and facilitators to community-wide MDA for STH from the perspective of various stakeholders.
3)To quantify the readiness of the health system to deliver community-wide MDA for STH programs.
4)To map the intervention delivery process and identify any discrepancies between planned and implemented activities in order to optimize the trial intervention.
5)To compare the financial and economic costs and incremental cost-effectiveness of community-wide and targeted MDA for STH in the short- and long-term.
Which strategies best strengthen strategic decision making for resilient and responsive health systems at the district level in Ghana, Malawi, Uganda and Tanzania?
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
To assess the relationships between the prevalence of the clinical sign TF compared to prevalence of infection and antibody in Chikwawa and Mchinji districts
Comparison of different diagnostic tools during onchocerciasis mapping, including Ov16 ELISA, OV16 rapid diagnostic test (RDT) and skin snip test.
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.
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.
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.