New Cohorts of Global TB Investigators To Start Rigorous Research Leadership Program

Locally driven research is at the centerpiece of months-long USAID-funded program to continue building local capacity for tuberculosis research 

BALTIMORE, April 25, 2024 — Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) is excited to welcome the second cohort of Early Stage Investigator (ESI) scholars. This year’s cohort reflects the depth and diversity of early career researchers, with a total of 50 scholars representing six countries in Africa and Asia. Simultaneously, SMART4TB is admitting 12 scholars from the first cohort to Phase II of the ESI program, a rigorous fellowship that hones in on researchers’ specific projects.

“This year’s cohort of Early Stage Investigators were impressive, reflecting the diverse background and interests of global researchers,” said Robert Bollinger, the Raj and Kamla Gupta Professor of Infectious Diseases at Johns Hopkins University. “It’s incredibly gratifying to meet new scholars and progress some of the scholars we trained last year into the next phase and see their research interests mature and solidify.”

Now in its second year, the first phase of the Early Stage Investigator program, is a 10-week intensive curriculum delivered by some of the world’s leading TB researchers. Topics include developing a research question and concept paper for a research proposal, engaging communities, designing a research study as well as reviewing and discussing their country’s current National Tuberculosis Program priorities. The countries represented in this new cohort include Nigeria, the Philippines, South Africa, Uganda,Vietnam and Zambia.

This Early-Stage Investigators’ Program creates unique opportunities for further enhancing the quality of locally led research by bringing investigators into direct contact with top-notch knowledge sources in TB research and education,” said Degu Jerene, a senior epidemiologist and team lead at KNCV Tuberculosis Foundation. “The program builds on what countries have started, paving the way to a sustainable model of capacity strengthening.”

After successful completion of Phase I of the program, scholars can apply to Phase II where they progress to the SMART4TB fellowship program that includes specific courses to help convert their research concept into a fully developed high quality TB research proposal. They receive mentorship from both a local and an internationally experienced SMART4TB faculty research co-mentor. Fellows also have access to strategic technical support consultations, including data management, biostatistics, research ethics, study design, implementation science and community engagement from SMART4TB experts. This year’s SMART4TB Phase II fellowship participants represent Mozambique, the Philippines, South Africa, and Zambia.

Márcia Chiluvane, a SMART4TB fellow from Mozambique described her experience as an ESI scholar. “The highlight was developing a research proposal that can address the challenges highlighted by my country’s National Tuberculosis Program. On this journey, I was surrounded and supported by a remarkable network of colleagues and mentors, both national and international, with vast expertise in tuberculosis.”

“The Early Stage Investigator program really speaks to the need for comprehensive mentorship for researchers early in their careers,” said Philip Hopewell, professor of medicine emeritus at University of California, San Francisco. “The research and ideas they produce will undoubtedly inform the field and strengthen local capacity in sustainable ways that will benefit future generations.”

###

The SMART4TB Consortium brings together experts in TB tools development, implementation science, capacity strengthening, civil society engagement and policy translation. Led by Johns Hopkins University, consortium members include  University of California, San FranciscoElizabeth Glaser Pediatric AIDS Foundation, KNCV Tuberculosis Foundation, and Treatment Action Group.

Global TB Diagnostic Study for Kids Begins Enrollment

The ADAPT for Kids study will evaluate accuracy of non-sputum tuberculosis diagnostic tests in children

BALTIMORE, February 15, 2024 — The Assessing Diagnostics at Point-of Care for Tuberculosis (ADAPT) for Kids study has enrolled its first participants at Instituto Nacional de Saúde (INS), Mozambique. ADAPT for Kids is evaluating promising TB diagnostic tests for children to inform World Health Organization (WHO) policy and ultimately provide children better, more accurate tests. The first tests studies will be tongue swab tests in children under 15 years, including children living with HIV. The study is led by Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) consortium.

TB is a leading cause of death in children, and almost all (96%) childhood TB deaths occur in children not on treatment due to missed diagnosis. Pediatric TB is underdiagnosed, in part because existing tests don’t work well in children. “Better tools for diagnosis at the point-of-care means a faster start to treatment, which is vital to ending these senseless TB deaths in children,” said Dr. Nilesh Bhatt, ADAPT for Kids investigator and global clinical research director at the Elizabeth Glaser Pediatric AIDS Foundation.

ADAPT for Kids will enroll children less than 15 years old with TB symptoms and risk factors, including children living with HIV. One of the first tests the study will evaluate utilizes tongue swabs to detect TB. Traditional TB tests rely on sputum, which is difficult for children to produce. “A tongue swab test would be a game changer, making TB diagnosis easier for both children and health systems to process and turn around,” said Dr. Celso Khosa, ADAPT for Kids investigator and director of the Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC) at Mozambique’s INS. ADAPT for Kids will generate critical evidence not just on test accuracy, but also on usability and acceptability among healthcare workers, critical components to ensuring effective tests are adopted by health systems and countries.

“Improving diagnostics is at the center of how we reach the ultimate goal of ending TB in Mozambique,” said Dr. Benedita Jose, the National TB program director in Mozambique. “We are excited to focus on children with this study and help get them access to the same cutting edge diagnostic technology that we look at for other populations.”

“SMART4TB is proud that the ADAPT for Kids study was developed and implemented in parallel and in collaboration with the ADAPT study in adults,” said Dr. Devan Jaganath, ADAPT for Kids investigator and assistant professor of Pediatrics at University of California, San Francisco. “Pediatric TB research too often lags behind, and SMART4TB is dedicated to closing research gaps for children by making sure we’re evaluating similar promising diagnostic technology in kids.” To further ensure standardized, high-quality evidence for children, ADAPT for Kids also is coordinating with the pediatric site with the U.S. National Institute of Allergy and Infectious Diseases-funded The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network).

A second ADAPT for Kids site at Mulago National Referral Hospital in Uganda, will be launched in the first half of 2024. Each site anticipates enrollment of 200-250 children per year.

###

The SMART4TB Consortium brings together experts in TB tools development, implementation science, capacity strengthening, civil society engagement, and policy translation. Led by Johns Hopkins University, consortium members include University of California, San FranciscoElizabeth Glaser Pediatric AIDS Foundation, KNCV Tuberculosis Foundation, and Treatment Action Group. SMART4TB is a cooperative agreement with the United States Agency for International Development (USAID), made possible by the generosity of the American people.The findings in this publication do not necessarily represent the views of the U.S. Agency for International Development or the U.S. Government.

SMART4TB Announces Partners In Developing Groundbreaking Oral, Non-sputum-Based Molecular Tests For Tuberculosis

Significant investment in technology marks major advance in point-of-care testing, the highest priority diagnostic need for TB prevention and care 

BALTIMORE, January 9, 2024 — Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) is excited to announce Boditech Med, Co-Diagnostics, Nuclein and Molbio Diagnostics as partners in developing oral swab-based, point-of-care molecular TB tests.

“The United States Agency for International Development’s (USAID) strategic investment in diagnostics technology for TB is an area ripe for innovation,” said Claudia Denkinger, head of the Division of Infectious Diseases and Tropical Medicine at University Hospital Heidelberg. “COVID-19 showed us that with the right incentives, many developers could utilize technology they were already working on to create efficient, scalable tests for different diseases. We have a similar ambition for TB, and this investment marks a vital step in the right direction.”

According to the World Health Organization’s ​​2023 Global Tuberculosis Report, 10.6 million people fell ill with tuberculosis  (TB) in 2022; 3.1 million were not reported because they were either not diagnosed or were diagnosed and not linked to care. Rapid molecular TB testing through platforms such as GeneXpert and Molbio has been an important advancement for TB by providing faster, more accurate diagnoses, including the detection of drug resistance. However, these tests largely still rely on sputum samples, which can be difficult to produce, and require infrastructure that challenges their use in a range of places where people seek care. To effectively treat people in settings where they are more likely to visit, healthcare providers need a test that is fast, accurate and can be conducted in any clinical setting.

“Rapid tests at the point of care for a person with TB is a game-changer. From the perspective of people with TB, it means getting a faster diagnosis and planning for potential treatment. From the clinician’s and program’s perspective, rapid, point-of-care testing can reach more people and improve the entire cascade of care, from prevention through treatment to contract tracing,” said Adithya Cattamanchi, chief, Division of Pulmonary Diseases and Critical Care Medicine at University of California, Irvine.

Developers were selected by a panel of 11 TB and diagnostics experts from academic institutions,USAID and​​ prominent organizations. The developers already have point-of-care molecular platforms in pre-commercialization or commercialization phase. In this effort, SMART4TB will provide financial and technical support to help adapt their technology to TB, and clinical support and regulatory guidance to help bring the final product to communities affected by TB.

“We’re excited about these partners because of the innovation they showed in their applications,” said Yuka Manabe, director at the Center for Innovative Diagnostics for Infectious Diseases at Johns Hopkins University School of Medicine. “We believe they have a high chance of success in bringing a test to market on an aggressive timeline and ultimately, bringing TB care close to many more people.”

This project has three development phases, from prototype to a design-locked clinically evaluated test. Partners selected for the first phase will only move to the next phase if their test meets designated standards and will be evaluated by a series of experts, including affected community members.

###

The SMART4TB Consortium brings together experts in TB tools development, implementation science, capacity strengthening, civil society engagement, and policy translation. Led by Johns Hopkins University, consortium members include University of California, San FranciscoElizabeth Glaser Pediatric AIDS Foundation, KNCV Tuberculosis Foundation, and Treatment Action Group. SMART4TB is a cooperative agreement with the United States Agency for International Development (USAID), made possible by the generosity of the American people.The findings in this publication do not necessarily represent the views of the U.S. Agency for International Development or the U.S. Government.

Enrollment Begins For Studying Evaluating Accuracy Of Point-of-Care Tuberculosis Diagnostic Tests

The ADAPT study will collaborate with global partners in this space as part of the largest-ever coordinated effort to further TB diagnostic development

BALTIMORE, November 7, 2023 — The USAID-funded Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) award is excited to announce enrollment of study participants in Nigeria, Zambia and the Philippines in the Assessing Diagnostics at Point-of Care for Tuberculosis (ADAPT) study. This study seeks to identify and assess promising novel point-of-care TB tests that do not rely on sputum. The study will generate evidence to inform World Health Organization (WHO) review and ultimately, uptake of new, effective diagnostic tests in TB high-burden countries.

“Better diagnostics that work where patients seek care are key to finding the 3.1 million people with TB who go undiagnosed each year,” said Adithya Cattamanchi, chief, Division of Pulmonary Diseases and Critical Care Medicine at University of California, Irvine. “Our goal with this study is to evaluate tests that are easier on patients and that could produce fast, reliable results in diverse healthcare settings.”

Partnering with the U.S. National Institute of Allergy and Infectious Diseases-funded The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network), Feasibility of Novel Diagnostics for TB (FEND-TB), FIND and Unitaid-funded DriveDx4TB, ADAPT will first rigorously evaluate the performance of Tongue Swab Xpert Ultra and Truenat MTB Plus, two WHO-endorsed rapid molecular tests for TB to determine whether they are an effective alternative method for diagnosing TB. SMART4TB is partnering with the Zankli Research Centre at Bingham University in Nigeria, De La Salle Medical and Health Sciences Institute (DLSMHSI) in the Philippines and Centre for Infectious Disease Research in Zambia (CIDRZ). Across these sites, the study will enroll 900 participants who present to health clinics with a cough for two or more weeks and/or have TB risk factors plus a positive World Health Organization (WHO)-recommended TB screening test, including key populations such as close contacts of people with TB, adolescents and people living with HIV.

“The difference a tongue swab test could make for patients—particularly young people and people living with HIV, who struggle to produce sputum—cannot be underestimated, influencing everything from their likelihood of getting tested to moving them more rapidly towards treatment options,” said John Bimba, director of the Zankli Research Centre.

“We need diagnostics tests that are user friendly. Healthcare settings for TB can vary widely and one of the goals with any new test is how well our staff is able to repeatedly conduct it. We will be looking at that closely with both tests,” said Charles Yu, former vice chancellor for research services and a professor at the College of Medicine of the De La Salle Medical Health and Sciences Institute.

“Rapid, low-cost and accurate tests can play a major role in ending TB in Zambia. We are looking forward to seeing the results and hope this study plays a role in transforming TB care globally,” said Monde Muyoteta, program director for TB at the Centre for Infectious Disease Research in Zambia.

Researchers expect to have initial results from the study to share in March 2024.

###

The SMART4TB Consortium brings together experts in TB tools development, implementation science, capacity strengthening, civil society engagement, and policy translation. Led by Johns Hopkins University, consortium members include University of California, San FranciscoElizabeth Glaser Pediatric AIDS Foundation, KNCV Tuberculosis Foundation, and Treatment Action Group. SMART4TB is a cooperative agreement with the United States Agency for International Development (USAID), made possible by the generosity of the American people.The findings in this publication do not necessarily represent the views of the U.S. Agency for International Development or the U.S. Government.

SMART4TB Consortium Welcomes United Nations’ Commitment To Tuberculosis Research and Innovation, Stands Ready To Bolster Global Research Capacity

NEW YORK CITY, September 25, 2023 — Following the United Nations (UN) High-Level Meeting on the fight against Tuberculosis, the Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) Consortium welcomes the UN’s commitments to ending tuberculosis (TB), particularly through advancing research and access for neglected populations. In a week in which health systems and public health coordination took the global center stage, the overwhelming need for cutting edge research that is effective and responsive to the needs of affected communities was a critical theme. Member states committed to mobilizing $5 billion for TB research per year by 2027 and affirmed the right of all people to “enjoy and share the benefits of research and innovation.”

“We are heartened to see countries uniting in recommitting to end TB, and especially in asserting the importance of research, access and affordability of evidence-based tools to achieve ambitious goals,” said SMART4TB chief of party, Dr. Richard Chaisson, professor of medicine at Johns Hopkins University School of Medicine. “Making good on these commitments is vital. SMART4TB stands ready to support countries in their realization throughout our research and policy activities.”

SMART4TB’s key research areas include diagnostics, therapeutics, vaccine preparedness and strengthening research capacity. Among the current and planned consortium activities that will support commitments made by the UN are:

  • Assessing point-of-care TB diagnostics to close the diagnosis gap, including for children, through the ADAPT and ADAPT for Kids studies;
  • Evaluating the anti-TB drug bedaquiline as preventive treatment for all forms of TB in adults, children and pregnant women (BREACH-TB);
  • Improving drug-resistant TB treatment with regimens based on individual baseline risks of poor treatment outcomes (PRISM-TB);
  • Testing shorter treatment for children with drug-susceptible TB with a stratified approach (SMILE-TB);
  • Ensuring the appropriate inclusion of pregnant women in TB research;
  • Developing locally led operational research studies in partnership with country missions and research stakeholders;

  • Supporting engagement and innovation from the research community in high burden countries through the Early Stage Investigator program, with mentorship and training;
  • Centering people and affected communities in all the above, through three regional community advisory boards: AfroCABTreatment Access Partnership (AfroCAB), Asia Pacific Council of AIDS Service Organizations (APCASO) and Eurasian Community for Access to Treatment (ECAT).

SMART4TB welcomes collaboration with partners from affected communities, researchers in high-burden countries, and policymakers at the national and global levels to accelerate the end of TB.

###

The SMART4TB Consortium brings together experts in TB tools development, implementation science, capacity strengthening, civil society engagement, and policy translation. Led by Johns Hopkins University, consortium members include University of California, San FranciscoElizabeth Glaser Pediatric AIDS Foundation, KNCV Tuberculosis Foundation, and Treatment Action Group. SMART4TB is a cooperative agreement with the United States Agency for International Development (USAID), made possible by the generosity of the American people.The findings in this publication do not necessarily represent the views of the U.S. Agency for International Development or the U.S. Government.