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Principal Investigator: John Lucian Davis
Organization: YALE UNIVERSITY
Fiscal Year: 2024
Award: $166,091
Funding agency: National Institute of Allergy and Infectious Diseases
PROJECT SUMMARY
Nearly one-third of the 10 million annual tuberculosis (TB) cases worldwide are missed each year. TB
contact tracing is an evidence-based practice that is internationally recommended for finding, treating,
and preventing TB among close contacts of TB patients. Contact tracing is also considered a highly
significant strategy for advancing the WHO and PAHO goal of eliminating TB in moderate-incidence
countries like Colombia by 2050. Unfortunately, large implementation gaps persist. Specifically there is
need for 1) better TB screening and testing tools to overcome the low sensitivity of symptom screening
and the difficulty of collecting sputum in those without cough, and 2) more client-centered
implementation strategies to improve case-finding and linkage to care. In prior work with the Secretariat
of Public Health (SPH) in Cali, Colombia, we introduced client-friendly education materials, home
sputum collection and transport, and molecular testing for TB. The COVID-19 pandemic has led to
further evolution of this service to accommodate telehealth visits, and there is need to further adapt
these tools to client expectations and the new digital health landscape. Two of the most promising
innovations for achieving these goals are pairing next-generation molecular testing with non-sputum
samples like saliva and oral swabs to simplify and improve screening and testing algorithms; and
incorporating chat apps (e.g., WhatsApp) and automated customer support tools (i.e., chatbots) as
mobile health (mHealth) tools to engage, support, and retain household members. Our scientific
approach will be to carry out two cross-sectional studies with nested mixed-methods and design
research to refine and adapt these tools for contact tracing. Our overall objectives are to enhance the
sensitivity, feasibility, acceptability, and appropriateness of contact tracing, and to prepare for a future
household-randomized implementation trial. We propose two specific aims: 1) To determine the
diagnostic performance of oral samples for TB molecular testing in possible TB patients in clinic and
household settings; and 2) To design and iteratively refine an mHealth strategy for implementing
contact tracing optimized for feasibility, acceptability, usability, and appropriateness. The investigative
team has expertise in TB diagnostics and clinical care, contact tracing, user-centered design, qualitative
methods, and implementation science, and a well-established partnership with the SPH that will ensure
an outstanding environment for the proposed research. These studies will determine if oral samples
are viable for molecular diagnosis of TB and refine an mHealth strategy for household TB contact
tracing, using an innovative design approach that is both theory-informed and community-engaged.
This study will ultimately deliver client-centered implementation components for an mHealth contact
tracing strategy for future evaluation in a randomized, controlled implementation trial.
Terms: <0-11 years old><21+ years old><Accuracy of Diagnosis><Adult><Adult Human><Affect><Age><Algorithms><Assess implementation><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Caring><Cell Phone><Cellular Phone><Cellular Telephone><Cessation of life><Child><Child Youth><Children (0-21)><Client><Clinic><Collection><Colombia><Communicable Disease Contact Tracing><Communicable Diseases><Communities><Contact Tracing><Coughing><Country><Cross Sectional Analysis><Cross-Sectional Analyses><Cross-Sectional Studies><Cross-Sectional Survey><Data Collection><Death><Diagnostic><Diagnostic tests><Disease Frequency Surveys><Education><Educational Materials><Educational aspects><Ensure><Environment><Epidemic><Evaluation><Evidence based practice><Evolution><Focus Groups><Friends><Future><Goals><Health system><Home><Household><Implementation assessment><Incidence><Individual><Infectious Disease Contact Tracing><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Instruction><International><Intervention><Intervention Strategies><Interview><Knowledge><Liquid substance><Lung TB><Lung Tuberculosis><M tb><M tuberculosis><M tuberculosis infection><M. tb><M. tb infection><M. tuberculosis><M. tuberculosis infection><M.tb infection><M.tuberculosis infection><MTB infection><Maps><Methodology><Methods><Microscopy><Mobile Phones><Modification><Molecular><Molecular Diagnosis><Motivation><Mycobacterium tuberculosis><Mycobacterium tuberculosis (MTB) infection><Mycobacterium tuberculosis infection><Newly Diagnosed><Oral><Outcome><PAHO><Pan American Health Organization><Patients><Performance><Persons><Prevention><Privatization><Procedures><Public Health><Public Health Service><Pulmonary TB><Pulmonary Tuberculosis><Qualitative Methods><Qualitative Research><Randomized><Recommendation><Research><Research Design><Research Methodology><Research Methods><Research Resources><Research Specimen><Resources><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Saliva><Sampling><Services><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Specificity><Specimen><Sputum><Study Type><Survey Instrument><Surveys><Swab><Symptoms><TB diagnosis><TB diagnostics><TB infection><Techniques><Testing><Time><Tuberculosis><Tuberculosis diagnosis><USPHS><United States Public Health Service><Visit><Work><adulthood><ages><analytical method><arm><behavior change wheel><case finding><chat bot><chatbot><clinical care><clinical diagnostics><conversational agent><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><design><designing><diagnosed with TB><diagnosed with Tuberculosis><diagnostic accuracy><digital health><disseminated TB><disseminated tuberculosis><evaluate implementation><evaluation of implementation><evidence base><expectation><fluid><homes><iPhone><implementation evaluation><implementation science><implementation strategy><implementation trial><impoverished communities><improved><infection due to Mycobacterium tuberculosis><informant><innovate><innovation><innovative><interventional strategy><kids><liquid><m-Health><mHealth><medical diagnostic><member><mobile health><mtb><next generation><novel><poor communities><poverty communities><prevent><preventing><qualitative reasoning><randomisation><randomization><randomly assigned><recruit><research and methods><retention rate><retention strategy><sample collection><screening><screenings><secondary outcome><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><sex><smart phone><smartphone><specimen collection><strategies for implementation><study design><support tools><telehealth><theories><tool><trial enrollment><tuberculosis diagnostics><tuberculosis infection><tuberculous spondyloarthropathy><uptake><usability><user centered design><video call><video calling><video chat><video phone call><vulnerable community><youngster>