Vacc-iNTS Invasive Non-Typhoidal salmonellosis cost of illness study and cost effectiveness
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Date
2021-03-15
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Kamuzu University of Health Sciences
Abstract
Type of research: This is a cost of illness and cost of effective analysis study. It is a prospective facility-based cohort study to
determine the individual, healthcare provider, and societal economic burden of non-invasive typhoidal
Salmonella (iNTS). This is a multisite study in Sub-Saharan Africa that includes Malawi, Burkina Faso Ghana.
Problem : iNTS disease poses a substantial economic burden on poor families as well as depletes already limited
health care resources. Economic burden of iNTS disease can be better understood by cost of illness (COI)
studies and the lack of iNTs Typhoid Fever (TF) COI data is considered a major knowledge gap. As such,
data from this study is essential for measuring the cost-effectiveness of vaccination or other disease
preventative interventions which will help set priorities, guide policies, and allocate resources accordingly.
Objectives: The primary objectives of this study is are to estimate the cost of illness of laboratory confirmed iNTS
disease. and to estimate the cost effectiveness of GMMA-based iNTS vaccine introduction in Ghana,
Burkina Faso and Malawi. Secondary objectives will estimate the excess costs of drug resistant iNTS disease in comparison with drug susceptible iNTS . and to estimate the cost effectiveness of GMMA-based
iNTS vaccine introduction in Ghana, Burkina Faso and Malawi.
Methodology
There are two health economic components under proposed COI study, health facility costing and patient
out of pocket costing (Figure 1). The health facility costing will be a one-time activity, whereas patient out
of pocket costing will involve prospective follow-up with a serial cross-sectional survey of incident cases.
These health economic studies are embedded into existing iNTS case surveillance and will use the same
platform set-up for surveillance. The COI study will involve recruitment of blood culture confirmed iNTS
cases.
Consented laboratory confirmed blood culture positive cases will be enrolled soon after their blood
culture results are available. At the time of first COI survey contact, cases will be interviewed after
providing written informed consent to collect their expenditures and loss of income until the previous day.
A second interview will be conducted between 10-20 days from the blood sample collection day to collect
subsequent costs and loss of income. If the subject continues to feel sick, a third interview will be
conducted 4 weeks from the blood sample collection day (day 28-30). We expect that most subjects will
have 2 to 3 interviews, however if subjects continue to be sick, the last interview will be collected on 90th
day.
Expected findings and dissemination
The International Vaccine Institute(IVI) will prepare one or more summary manuscripts reporting cost of
illness of laboratory confirmed cases (iNTS) along with country investigators. Authorships and their order
will be determined based on individual contributions to the study. Site investigators will be included as
co-authors in order decided by their contributions.
Following the publication of an initial article the project’s principal investigator and project coordinator
will discuss publication scenarios with site representatives, help identify the lead scientists who will be
responsible for drafting of the manuscript and provide scientific oversight for each possible publication.
Authorships and their order will be determined based on individual contributions to the studies.
Research findings will be disseminated locally through scientific group meetings, research and group
meetings, research and progress meetings at the College Of medicine and MLW and nationally through the annual College of Medicine research dissemination conference. Results will also be reported to College
of Medicine Research Ethics Committee (COMREC). Peer reviewed publication of findings is anticipated.
We anticipate the following constraints in the study: Delay in completing the planned activities on time due to travel restriction or general hindrance caused by the COVID-19 situation, slow enrolment due to insufficient number of iNTS disease cases or in general we may have too few cases and if COVID-19 continues into 2021 study staff visiting and interviewing patients may be at risk.
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Research Subject Categories::MEDICINE