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Global Health Awarded Catalyzers

The purpose of these grants are to provide research support to Northwestern faculty who are a) collecting preliminary data to support a future grant submission and/or b) supplemental support for ongoing sponsored-research for work outside the aims and/or scope of work of the funded project. The fund is not meant to support the same aims of an existing study or projects that lack a specific plan to obtain sponsor-support.

The Global Health Research Catalyzer Fund is supported by the Feinberg School of Medicine’s Global Health Initiative, which is generously supported by Northwestern Medicine Primary & Specialty Care, its patients, and Feinberg’s donors.

For more information on the COVID-19 Research Catalyzer Fund, please visit here.

 Assessing the Contribution of Children Over Five Years of Age to Malaria Transmission in Northern Ghana
Ghana, Spring 2021

Malaria epidemiology is changing in response to successfully targeting the most vulnerable populations with effective interventions. Since 2012, seasonal malaria chemoprevention (SMC), a highly effective measure against malaria morbidity and mortality in children under 5, has been scaled up in a number of high-burden Sub-Saharan African countries. As the epidemiology of the most vulnerable group shifts from children under 5 to older children, countries are considering expanding SMC to include children as old as 10 or even 15. Predicting the impact and costeffectiveness of expanding SMC requires quantitatively characterizing how much each age group contributes to the true infectious reservoir of malaria and thus how targeting each piece of the infectious reservoir impacts populationwide transmission. In this pilot study, we propose to examine the infectiousness of a cohort of individuals living in a highly seasonal community in Northern Ghana. A total of 160 volunteers in four age groups (children under 5, children 5-10, children 10-15, and individuals over 15) will be assessed for their infectiousness to female Anopheles mosquitoes by direct membrane feeding assay. To account for biting risk and parasite clearance through treatment, the usage rate of insecticide-treated nets and treatment-seeking rates will also be measured for each age group. All measurements will be incorporated into a mathematical model to assess the epidemiological impact of expanding chemoprevention in Northern Ghana. This study will quantify the contribution to transmission of various age groups of communities in which SMC is implemented as well as the impact of expanding such intervention to include higher age groups.

Quick Facts

Country: Ghana

Partner Institutions: University of Ghana, Ghana

Principal Investigator: Jaline Gerardin, PhD

Site-Principal Investigator: Yaw Afrane, PhD and Linda Amoah, PhD, University of Ghana

 Determination of Feasibility and Acceptability of Newborn Screening in Nepal: A Pilot Study
Nepal, Spring 2021

We propose a pilot study to determine the feasibility and acceptability of introducing universal newborn screening in Nepal, limited to two hospitals in Kathmandu. The objectives are: (1a) to determine the feasibility of establishing newborn screening in Nepal, using a limited number of actionable disorders that can currently be confirmed and managed in Nepal (congenital hypothyroidism, congenital adrenal hyperplasia, glucose-6-phosphate dehydrogenase deficiency, galactosemia, hemoglobinopathy, biotinidase deficiency); (1b) to establish a process map for sample collection, transport, newborn screening analysis and timely communication of results; (1c) to evaluate metrics that determine success of 1(a) and 1(b); (2) to determine acceptability of newborn screening introduction through surveys targeting knowledge, attitude and acceptability of universal newborn screening among all levels of pediatric providers; (3) to establish a biorepository of residual DBS for future genetic, genomic and epigenetic studies, as well as a repository for newborn screening results.

This study will inform future biomedical research into metabolic diseases in Nepal, with potentially tremendous impact on neonatal health care due to reduction in neonatal mortality and morbidity by early diagnosis and intervention, of previously undiagnosed conditions. However, questions regarding the ethical, legal and social implications surrounding newborn metabolic screening in Nepal remain unknown. The data from this pilot study will support an R21/PAR-20-255 grant submission to National Human Genomic Research Institute: Ethical, Legal and Social Implications Exploratory/Developmental Research.

Quick Facts

Country: Nepal

Partner Institutions: Paropakar Maternity Hospital and Medical College, Nepal

Principal Investigator: Janine Khan, MD

Site-Principal Investigator: Sunil Manandhar, MD

 Surgical Neonates in Low-Resource Setting: Baseline Nutrition and Outcome Assessment
Uganda, Spring 2021

Background: Neonatal mortality is an increasing cause of under-5 deaths in low-income countries (LICs). Surgical congenital anomalies such gastroschisis, esophageal atresia, and intestinal atresia are among the most lethal neonatal conditions, with 30-day mortality ranging from 60-85% in Uganda. These anomalies prevent oral/gastric feeding until recovery after surgery but delays in presentation and access to surgical care mean these babies often have to wait 10–20 days to be fed. Newborns deplete nutritional reserves within 5 days, consequently, severe malnutrition and electrolyte disturbances result in poor healing and high mortality. The standard of care in this circumstance is intravenous, or parenteral nutrition (PN). However, PN requires expensive laboratory and pharmacy services not available in Ugandan public hospitals. We propose nutritive enema feeding (NEF) as a perioperative nutritional "bridge" until these babies can feed by mouth. NEF has successfully nourished adults, prior to development of IV fluids/PN, and recently fed two infants after intestinal resections in Sweden and Nepal. Similar to absorption of suppository medications, NEF extends this to enema delivery of breastmilk with lactase as a cheap, developmentally appropriate nutrition source. NEF may be safer than PN where resources or sterile conditions are suboptimal. Prior to investigating the safety, feasibility, and efficacy of NEF, we need an accurate baseline comparison sample. We propose a catalyst study to evaluate baseline characteristics, peri-operative morbidity, growth, enteral feeding tolerance, and mortality in surgical neonates in Uganda.

Hypothesis(es) and Aims: Neonates with congenital GI anomalies will have prolonged fasting states, with significant morbidity and mortality in the absence of substantive nutrition.

Aim 1. Collect baseline data on survival and nutrition in surgical neonates. Prospective evaluation will include weight gain, morbidity, including electrolyte disturbance, and mortality.
Aim 2. Build research capacity in the Pediatric Surgery team at Mulgao National Referral Hospital (MNRH).
Experience doing a prospective study will develop expertise in research, facilitating future interventional studies. This will be measured by rates of enrollment, missing data, and qualitative assessment of the team's experience through structured interviews.

Design: A prospective cohort study of 40 neonates treated at MNRH in Kampala, Uganda for surgical GI anomalies.
1. Subjects: children > 30 days of age with esophageal atresia, intestinal atresia, and gastroschisis, treated by the Pediatric Surgical team. Exclusion criteria: colon or anorectal malformations, concern/evidence of bowel ischemia or perforation, and weight < 1.5 kg.
2. A sample size calculation is not possible, but 40 patients should provide data on at least 15 survivors. Currently, approximately 8 eligible neonates present to MNRH/month, allowing study enrollment within 8 months.
3. Primary outcomes: 30-day survival, complication rate, weight gain (g/day), incidence of abnormal serum
electrolytes, time to full oral feeding (days).

Potential Impact: A baseline comparison group will allow accurate assessment of the safety and efficacy of breastmilk NEF in a prospective study of neonatal nutritive enemas. This data could inform an NIH R21 study of NEF in babies in LICs without access to PN in the perioperative period.

Quick Facts

Country: Uganda

Partner Institutions: Makerere University College of Health Sciences, Uganda

Principal Investigator: Monica Langer, MD

Site-Principal Investigator: Phyllis Kisa, MD

 Nigeria Sodium Study: Integrating into the African Food Composition Database
Nigeria, Fall 2020

The objective of the Nigeria Sodium study is to evaluate implementation and scale-up of Nigeria's national sodium reduction program. Our team's 6-year award from the National Heart, Lung, and Blood Institute will perform repeated cross-sectional data collection at Years 1, 3, and 5 of: 1) population surveys to estimate dietary sodium intake, 2) retail surveys to estimate sodium in the packaged and unpackaged food supplies, and 3) stakeholder interviews to evaluate perspectives on implementation and scale-up of dietary sodium policies using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework. Within the population surveys component of the Nigeria Sodium Study, we will collect information about the dietary sources of sodium in the Federal Capital Territory, Ogun, and Kano states to better target sodium reduction policies. The objective of this Catalyzer proposal is to integrate data collected from the Nigeria Sodium Study into the Nutrition Data System for Research (NDSR) at the University of Minnesota's Nutrition Coordinating Center, specifically its African Food Composition Database. This integration will create a research and training platform for reliably estimating sources of dietary sodium, as well as for evaluating other dietary sources of nutrients related to cardiovascular health, including trans fats, saturated fats, added sugars, among others for future nutrition research studies.

Quick Facts

Country: Nigeria

Partner Institutions: University of Abuja, Nigeria

Principal Investigator: Mark Huffman, MD, MPH

Site-Principal Investigator: Dike Ojji, PhD

 SARS-CoV-2 in Exhaled Breath
South Africa, Fall 2020

The SARS-CoV-2 virus causes COVID-19, a serious illness which has created a world-wide health crisis. Limitations in both testing for the disease and our understanding of its transmissibility have contributed to the spread of the virus. The virus is thought to spread through respiratory droplets contained in exhaled breath of patients who have COVID-19. We have developed a method for detecting SARS-CoV-2 virus on the exhaled breath condensate (EBC) of COVID -19-positive patients. Our method is inexpensive, noninvasive, safe, portable, and simple enough for patients to perform at home. It involves breathing naturally into a cooled tube for 5 - 10 minutes. It can be easily used in clinical or home settings, is ideal for longitudinal studies. EBC samples contain bioactive molecules originating along the entire respiratory airway, including deep inside the lungs. By analyzing EBC samples with RT-qPCR, our method provides a direct measure of the level of SARS-CoV-2 virus RNA present in an individual's exhaled breath. This may be impactful as a diagnostic tool, and as a measure of contagiousness of an individual patient. A test for COVID-19 that measures viral load from the entire respiratory airway and can be self- administered by patients would address significant shortcomings of clinic-based testing, benefitting patients, clinical and hospital staff, and public health efforts. Furthermore, a breath-based test that has the ability to determine how contagious an individual is could be extremely useful for efforts to contain the disease, triage patients, and help guide public health decision-making by potentially allowing the identification of potential superspreaders. We have conducted a preliminary proof-of-concept study, in which we detected SARS-CoV-2 in the exhaled breath of COVID-19 outpatients diagnosed via nasopharyngeal swab performed in the emergency room. We are now seeking funding to move our project to the next level. We plan to conduct a baseline validation study, which will allow us to directly compare our method to the nasopharyngeal swabbing method. We will obtain quantitative information about the viral load levels in exhaled breath samples, in order to begin to understand which patients are shedding particularly high levels on their breath, and to begin to understand the temporal dynamics of viral shedding in exhaled breath of COVID-19 patients. We will also compare the rate of false negatives in our samples versus nasopharyngeal samples. Our method also provides an opportunity to increase access to COVID-19 testing, particularly in under-served and under-resourced communities, because of its portability and ease of use. In line with our goal of widespread democratization, we will conduct our studies in parallel with our international collaborator, Dr. Grant Theron, at Stellenbosch University in South Africa. Dr. Theron has an established track record of collaboration with Northwestern University researchers. South Africa currently has the highest number of confirmed COVID-19 cases in Africa, and also has an advanced and highly centralized network of government reference laboratories that has allowed better documentation of the COVID-19 epidemic compared to neighboring countries.

Quick Facts

Country: South Africa

Partner Institutions: Stellenbosch University, South Africa

Principal Investigator: Christine Zelano, PhD

Site-Principal Investigator: Grant Theron, PhD

 Phylodynamics and Molecular Epidemiology of SARS-CoV-2 in Nigeria
Nigeria, Fall 2020

Our research team has already performed SARS-CoV-2 sequencing studies in the Chicago area. We detected distinct viral variants circulating since the beginning of the epidemic and found probable associations between these different variants and the transmissibility of the virus. In the current project, along with our collaborators in Nigeria, we will expand the viral sequencing capabilities and characterize the viral genomic epidemiology of SARS-CoV-2 in Nigeria. Our preliminary analysis of the few sequences available from Nigeria shows a high proportion of viral variants similar to the viruses we have found to be associated with lower viral loads in the upper respiratory tract, thus suggesting lower transmissibility. Our hypothesis is that Nigeria has been affected by SARSCoV- 2 variants with lower transmissibility, which may explain the lower expansion rate observed in the country. Additionally, differences in the types of viruses that dominate the epidemic in Nigeria could be a cause of the lower mortality rates observed. Thus, we will examine the viral dynamics and their association with patient data to assess if the viral epidemic in Nigeria is evolving towards more transmissible or pathogenic variants that could significantly increase the number of new infections. If on the other hand, the circulating strains in Nigeria are found to exhibit similar transmissibility as other regions, it would increase the imperative to search for environmental and host/immunologic factors that may explain the epidemiologic and clinical features of COVID-19 in the country. By providing a robust collection of viral genome sequences we will generate an invaluable resource for studying clinical responses to viral infection in Nigeria, as well as developing new prevention strategies, diagnostics, and therapeutics.

Quick Facts

Country: Nigeria

Partner Institutions: University of Ibadan, Nigeria

Principal Investigator: Ramon Lorenzo, PhD

Site-Principal Investigator: Dr. Adewumi

 Development of a Limited-Contact Patient-Posture Change Mechanism for Efficient Management of COVID-19 Patients
Nigeria, Spring 2020

The proposed patient-posture change mechanism is projected to be simple and mobile, with manually-operated and adaptable hoist device to aid in-hospital turning of the critically ill patients. The design will be carried out using computer-aided design software (Autodesk AutoCAD and Inventor). Using design specifications that are benchmarked with the ergonomic and anthropometric data of native African adult patients a new pneumatic system will be developed and utilised as the mechanism for making patient-specific inflatable bolsters in the conventional patient mattress. The system will then be assessed for the stress and dynamic characteristics of its inflatable bolsters, the system's energy and power requirements, as well as its effect on the posture-change time for patients. Both laboratory and clinical trials will be carried out, the laboratory one in two phases. In the first phase numerical model shall be carried out to simulate the stress profile and posture change for different loadings. In the second phase physical dummy load shall be utilised to assess the prospects of injury, discomfort and ease of operation using the developed mechanism. Clinical trials shall be carried using healthy and low-risk non-healthy volunteers.
Manpower requirement shall be assessed using standard laboratory facilities and will be compared with that of similar existing system(s). This proposed patient-turning device is projected to reduce the number of personnel needed to turn the critically ill patients in the ICU from the current maximum of about 6 per session to only 1, or at most 2. And the utility value of this system would be great not just for patients with COVID-19, but actually for all such critically ill in-hospital patients that need turning in bed.

Quick Facts

Country: Nigeria

Partner Institutions: University of Ibadan, Nigeria

Principal Investigator: Matthew Glucksberg, PhD

Site-Principal Investigator: Akinwale Coker

 Development of a Low-Cost Automated Adaptable Handwashing Device for Prevention of COVID-19 Spread
Nigeria, Spring 2020

In the absence of effective treatment and vaccine for the COVID-19, prevention remains the most pragmatic means of curtailing it. Hand washing with soap and running water is key in this regard. In the absence of functional public running water supply in most developing countries, the typical handwashing device in private and public places in Nigeria is mostly the ubiquitous Veronica bucket, a water receptacle whose water-dispensing tap one still needs to manually open with the same dirty hands to be washed: a counter intuitive thing indeed for preventing the spread of an infection. The aim of this project is two-fold. Firstly, we propose to develop a low-cost, automated, energy-efficient, adaptable and user friendly handwashing device for the prevention of the spread of COVID-19 and any other such communicable disease. This aspect of the project involves the design of a utility handwashing device with several working parts which can be procured (i) together to function as a single unit or (ii) rather individually to work independently of themselves, thus leaving room for potential clients to procure only that part which they can afford. These working parts include containers for water, soap, and or hand sanitizers which dispense their contents for the user under gravity; infrared motion sensors for opening the taps for these containers; and renewable energy supply (solar) for the low-energy requirement (about 20 W), but with the option of back-up battery. The second part of the project is the development of a user-friendly, and also adaptable receptacle for the handwashing effluent. In effect, the overarching vision of this project is the development of such a utility handwashing device that can be deployed anywhere in Nigeria, urban or rural areas; and that can be tailor-made to fit the needs of individuals and corporate users including homes, offices, corporate organisations, as well as such places of public gatherings like schools, markets, places of worship, malls, stadia and so on.

Quick Facts

Country: Nigeria

Partner Institutions: University of Ibadan, Nigeria

Principal Investigator: Mamoudou Maiga, MD, PhD

Site-Principal Investigator: Akinwale Coker

 Potential Impact of a Health Systems Strengthening Intervention on Resiliency of Maternal and Child Healthcare in Togo During COVID-19 Pandemic
Togo, Spring 2020

Global pandemics like COVID-19 result in increased mortality, not only from the virus itself, but from indirect effects due to disruptions in healthcare service delivery, mistrust of the health system, and lack of transportation due to closures, among other reasons. The impact of COVID-19 on maternal and child health care delivery and outcomes is particularly concerning in low- and middle-income countries whose health systems struggle to provide adequate healthcare under normal circumstances. Evidence from the Ebola outbreaks suggested that community health workers embedded in a trusted system may have mitigated the impact on uptake of critical life saving interventions such as malaria treatment and facility-based delivery. Collaborative projects between academic researchers, nonprofits, and governments can lead to effective and integrated health system interventions that can limit the impact of a pandemic on healthcare utilization and provide opportunities for producing generalized knowledge through integration of implementation research. The proposed project aims to strengthen the partnership between Northwestern University Institute of Global Health with Integrate Health (IH), a non-governmental organization, Albert Einstein College of Medicine and the Togolese Ministry of Health. The work will building on an ongoing study of the impact of a health system strengthening intervention on health care utilization, quality and U5 mortality. The intervention, Integrated Community-Based Health Systems Strengthening (ICBHSS), includes paid, supervised CHWs and targeted facility improvements. This ongoing stepped wedge hybrid type 2 design implementation research study started in 2018 2 years before COVID-19 (2 steps completed of 4) led by IH which implemented the intervention in 10 of the 25 facilities in 2 districts, with further steps on hold due to COVID-19. The catalyst will fund work in the first district with 2 years of intervention to 1) Aim 1. Measure the differences in change in maternal and under-five healthcare utilization related to the COVID-19 response and 2) Explore factors influencing maternal and under-five healthcare utilization in intervention facilities following the start of the COVID-19 pandemic. We hypothesize that intervention health facilities and their surrounding catchment areas will experience a lower decline in healthcare utilization than those without IH's ICBHSS model. The study proposed will inform a larger R01 study measuring the effectiveness of IH's integrated healthcare model on maternal and child health outcomes on health systems resiliency and builds on the existing collaboration between Northwestern University, Albert Einstein College of Medicine and IH's work in Togo.

Quick Facts

Country: Togo

Partner Institutions: Office of Community & Population Health- Montefiore Health System

Principal Investigator: Lisa Hirschhorn, MD, MPH

Site-Principal Investigator: Kevin Fiori, MD

 Incidence of SARS Co-V-2 Among Healthcare Workers at the National and Regional Referral Hospitals in Dar es Salaam, Tanzania
Tanzania, Spring 2020

In February 2020, the World Health Organization declared a Severe Acute Respiratory Syndrome CoronaVirus (SARS - CoV -2) infection as a global pandemic. There are now over 140,000 confirmed cases of COVID-19 across Africa and numbers continue to rise steadily in all countries, including Tanzania. Health care workers (HCWs) are at high risk for exposure to SARS-CoV-2 and clinical infection from COVID-19. Currently, there are no data on the prevalence or incidence of anti-SARS-CoV-2 IgG serology, nor the predictors or outcomes of IgG serology among Tanzanian HCWs who are at significant risk for COVID-19 infection. The objectives of this study are to create a longitudinal cohort of 400 Tanzanian HCWs and to: 1) describe the baseline prevalence and anti SARS2 IgG serology among HCW by age, sex, location, HCW type subgroup and other characteristics associated with serologic status, 2) assess the rate of seroconversion (IgG- to IgG+) and change in IgG titer at 3 and 6 months of follow-up, and 3) quantify the characteristics and outcomes associated with higher titers of anti-SARS-CoV-2 IgG among those who seroconvert using a dried blood spot based assay. This study will help us better understand seroprevalence and the kinetics of seroconversion among HCW and potential immunity and quantify the characteristics and outcomes associated with high titers of SARS-CoV-2 IgG. Our study will be closely aligned with three other studies examining serologic responses among HCW in Chicago, Mali, Guinea and Nigeria, results of which will enable us to determine how much COVID-19 has occurred among the healthcare workforce and the extent to which development of SARS-CoV-2 IgG could protect these essential workers against infection. Study findings will also have important implications for health care facilities which are prone to become hot spots for COVID-19 transmission.

Quick Facts

Country: Tanzania

Partner Institutions: Muhimbili University of Health & Allied Sciences (MUHAS) Tanzania

Principal Investigator: Claudia Hawkins, MD

Site-Principal Investigator: Tumaini Nagu, MD, MPH, MMED, PhD

 Nigeria Healthcare Worker SARS-CoV-2 Serology Study
Nigeria, Spring 2020

The objectives of this study are to create a longitudinal cohort of Nigerian health care workers (HCWs) and to: 1) describe the baseline prevalence and anti SARS2 IgG serology among HCW by age, sex, location, and HCW type subgroup and other characteristics associated with serologic status, 2) assess the rate of seroconversion (IgG- to IgG+) and change in IgG titer at 3 and 6 months of follow-up, and 3) quantify the characteristics and outcomes associated with higher titers of anti-SARS2 IgG among those who serocovert using a dried blood spot based assay.

Quick Facts

Country: Nigeria

Partner Institutions: University of Abuja, Nigeria

Principal Investigator: Mark Huffman, MD, MPH

Site-Principal Investigator: Dike Ojji, MD, PhD

 COVID-19 Outbreak: Seroprevalence Study of Health Care Workers in Mali
Mali, Spring 2020

The Coronavirus-2019 disease (COVID-19), caused by the SAR-CoV-2 virus, is spreading rapidly across the world, threatening millions of lives. However, the healthcare systems in low and middle-income countries (LMICs) of sub-Saharan Africa could ultimately be hit far harder than developed countries and may face major challenges due to their already fragile, under-funded, and under-resourced systems, and a considerable proportion of cases will be among frontline Health Care Workers (HCWs). We propose here to determine, among HCWs in Mali, the rate of PCRconfirmed SARS-CoV-2 infections and conduct longitudinal assessment of serological prevalence study in this important and exposed group, with the goal of optimizing the frontline HCW resource. This collaborative project will provide significant data about the transmission and infections rates among HCWs in Mali, which could enormous public health impact.

Quick Facts

Country: Mali

Partner Institutions: Universite des Sciences, des Techniques et des Technologies de Bamako MALI

Principal Investigator: Mamoudou Maiga, MD, PhD

Site-Principal Investigator: Sounkalo Dao

 Clinical and Virological Characterization of the Ongoing COVID-19 Pandemic in Mali and Guinea
Mali and Guinea, Spring 2020

The Coronavirus-2019 disease (COVID-19), caused by the SAR-CoV-2 virus, has spread rapidly across the world, threatening millions of lives. Many COVID-19 management solutions are being developed and implemented including longer-term solutions such as new therapeutics and a vaccine. However, potential mutation, over time, of the virus is highly possible given the environmental pressure in Africa with a warmer climate, low humidity, windy environment and other environmental factors. Mutations could be a major threat to the vaccine and medications being developed. Currently it is estimated that only 1% of SAR-CoV-2 isolates sequenced are from Africa, which could leave out the circulating strains in the continent in the ongoing vaccine designs. Our aims are: 1) Characterize the clinical presentation of COVID-19 cases in Guinea, and Mali; and 2) Determine the clusters and Examine the virological evolution of circulating SARS-CoV2 strains in Guinea and Mali, using whole genome sequencing. The project will provide significant data about the transmission and circulating strains in West Africa.

Quick Facts

Country: Mali and Guinea

Partner Institutions: Universite des Sciences, des Techniques et des Technologies de Bamako MALI

Principal Investigator: Mamoudou Maiga, MD, PhD

Site-Principal Investigator: Almoustapha Maiga, PhD

 Plasma and PBMC Repository to Elucidate the Immune and Cytokine Profile of SARS-CoV-2 Infected Nigerians
Nigeria, Spring 2020

The features, determinants and modulators of the host response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) are not well understood. Discoveries in this area will advance the quest for host-directed immune based therapies. Our main goal in this study is to elucidate the immune and cytokine profiles of SARS-CoV-2 infected Nigerians using samples collected from three major cities in the country. Through immune cellularity analysis, characterization of the human B cells and T cells specific to SARS-CoV-2 spike protein, and soluble cytokines and extracellular vesicle analyses, we will generate new knowledge from the most populous country in Africa. Residual samples will be stored for secondary research.

Quick Facts

Country: Nigeria

Partner Institutions:
University of Ibadan, Nigeria
Defence Reference Laboratory, Health Implementation Program, Ministry of Defence, Mogadishu Cantonment Abuja, Nigeria
Nigerian Institute of Medical Research, Lagos, Nigeria

Principal Investigator: Babafemi Taiwo, MBBS

Site-Principal Investigators:
Moses Adewumi
Mike Ebie
Rosemary Audu

 Immunologic and Inflammatory Factors Associated with Vulnerability to Infectious/Inflammatory Cardiomyopathy in Patients with Trypanosoma Cruzi Infection in Sao Paulo, Brazil
Brazil, Spring 2020

The purpose of this application is to identify immunologic, inflammatory, and metabolic factors implicated in vulnerability to Chagas disease and associated heart failure (HF) among people infected with the Trypanosoma cruzi (T. cruzi) parasite. Globally, HF affects at least 38 million people, accounts for more premature life years lost from cancer, and is the fastest growing cardiovascular condition in the world – particularly in low and middle income countries (LMICs). LMICs are disproportionately affected by infectious and inflammatory etiologies of cardiomyopathy and HF, and Chagas disease is the most common cause of non-ischemic cardiomyopathy in Latin America. However, only a portion of people infected with T. cruzi experience Chagas disease/HF for reasons that remain unclear. As in other endemic cardiomyopathies – including but not limited to human immunodeficiency virus (HIV)-associated cardiomyopathy – vulnerability to maladaptive, ultimately autoreactive and mistargeted immune responses appear to drive the onset and progression of cardiomyopathy and HF among people with T. cruzi. Yet, the precise immune, inflammatory, and metabolic factors underlying cardiomyopathy development and progression in T. cruzi are poorly defined.

Therefore, in this application, we propose to expand a promising collaboration between Northwestern University and Sao Paulo University's Instituto do Coracao (InCor), which is the largest heart hospital in Latin America and houses the largest cohort (with associated biosamples) of people infected with T. cruzi, with and without cardiomyopathy. We aim to use a validated platform of 358 protein biomarkers representing relevant pathways related to immune response, inflammation, and cardiometabolic disease to identify markers most strongly associated with HF among people with T. cruzi. Then, in an exploratory analysis leveraging the PI's existing data using the same highdimensional platform, we will determine common and distinct factors associated with HF for people with T. cruzi vs. people with HIV (with and without HF) and people without either of these infections (with and without HF). We expect that we will identify novel common and disease-specific factors underlying HF in T. cruzi, which we will then investigate further in analyses (and applications for funding) focused on early diagnosis, prevention, and treatment of Chagas disease among T. cruzi patients. More broadly, our analyses offer potential diagnostic importance in that they may identify people with endemic infections who have the highest vulnerability to HF; this may highlight targets for early HF prevention and intervention in these infectious states as well as in other infectious and inflammatory conditions.

Quick Facts

Country: Brazil

Partner Institutions: University of São Paulo School of Medicine (FMUSP), São Paulo, Brazil

Principal Investigator: Matthew Feinstein, MD

Site-Principal Investigator: Edecio Cunha-Neto, MD, PhD

 A Pilot Registry for Estimating the Burden of Neurotrauma among Tertiary Care Hospitals in Peru
Peru, Spring 2020

Traumatic brain injury (TBI) and spinal cord injury (SCI) are leading causes of disability and a major public health issue due to its socioeconomic impact. TBI and SCI correspond to approximately 55 million (estimated range 53–58 million) and 27 million (estimated range 25–30 million) prevalent cases. Data collection methodologies and elements tailored for resource limited settings in low-and middle-income countries remains poor but essential for guiding health services interventions and policies. We propose a retrospective collection of national data from tertiary care centers to identify a subset of high-volume trauma centers and subsequent piloting of a prospective registry among 3-4 hospitals. The registry will validate an existing virtual platform already in use in Latin America, Registro Latinoamericano de Neurotrauma (RED LATINO) by Fundación MEDITECH, to better characterize the patient population suffering from TBI and SCI and to help target context specific interventions for future funding opportunities.

Quick Facts

Country: Peru

Partner Institutions: Universidad Peruana Cayetano Heredia, Lima, Peru

Principal Investigator: Roxanna Garcia, MD, MS, MPH

Site-Principal Investigator: Patricia Garcia, MD, MPH, PhD

 Examining the Prevalence of Cardiovascular Disease Risk Factors and the Cascade of Cardiovascular Disease Care Among Tanzanians Living with HIV
Tanzania, Spring 2020

The success of current efforts to improve HIV health care delivery is evident from the global increase in life expectancy among people living with HIV (PLWH). For the past decade, life expectancy of people living with HIV in Sub-Saharan Africa (SSA) has exponentially grown to approximately match that of the general population. Similar to the general population, PLWH are at risk of developing cardiovascular disease (CVD) as part of the normal ageing process. PLWH are at higher risk for CVD as a result of constant immune activation caused by chronic exposure to HIV infection, and long-term use of antiretroviral therapy (ART). Research has documented a two-fold increase in the risk of CVD among PLWH compared to the general population. CVD is a major cause of premature death in SSA countries including Tanzania. In this region, CVD has a large economic impact to the household and the government due to catastrophic health expenditure and through loss of income and labor productivity. About ninety percent of CVD are preventable. Strategies for prevention through early detection and management of CVD risk factors (namely hypertension, diabetes, overweight/obesity and dyslipidemia) are relatively cost-effective compared to the cost of managing CVD once diagnosed. The prevention of CVD is therefore of paramount importance among PLWH given the higher risk of CVD in this population. In addition, PLWH already endure significant health care costs associated with HIV including those from lifelong treatment. For this population, prevention of CVD through early screening and management of CVD risk factors remain the cornerstone for interventions to reduce the burden of CVD. Current Tanzania national guidelines for management of HIV/AIDS recommends screening for hypertension among other CVD risk factors during every visit to the HIV clinic. Health care workers are required to provide health education on lifestyle modification and early referrals for treatment for clients with or at risk of developing CVD. However, despite these recommendations, data on the proportion of people living with HIV at risk of developing CVDs who are aware, screened and on treatment for those risk factors is limited. Furthermore, there is paucity of data on the burden of CVD and associated risks in PLWH. The current study aims to assess the burden of risk associated with CVD in Tanzanian adults living with HIV and the CVD care continuum in HIV clinics. The overall goal of this study is to identify gaps in CVD care in PLWH that can be intervened on by policy makers to improve the quality and impact of HIV and CVD care in Tanzania. This study will also identify participants for future patient-centered studies that will measure patient experiences and outcomes among PLWH and at risk for CVD in Tanzania.

Quick Facts

Country: Tanzania

Partner Institutions: Muhimbili University of Health and Allied Sciences, Tanzania

Principal Investigator: Claudia Hawkins, MD, MPH

Site-Principal Investigator: Theresia Ottaru

 Biological Memories of Apartheid: Intergenerational Effects of Apartheid-based Prenatal Stress on HPA Axis Function, Inflammation, and Mental Health in Soweto, South Africa
South Africa, Spring 2020

While it is increasingly understood that childhood trauma exposure raises a child's future risk of adult depression andother mental illnesses, new data suggest that positive social experiences such as social support, particularly duringadolescence, can reverse the programming effects of early adversity on stress physiological systems. Althoughpregnancy and childhood are critical periods in key stress biological systems, specifically the hypothalamic-pituitaryadrenal (HPA) axis, the system undergoes another major resetting during the neuroendocrine changes thatcoordinate puberty. HPA axis resetting is understood to have widespread effects on the brain as well as the regulation of cortisol and inflammation. Despite the potential for social support to reverse early life stress-initiated HPA axis dysregulation in adolescence, to date very few studies have evaluated the long-term ameliorative effect of social support during adolescence on adult health and biology. This study proposes two three key aims: 1) to assess the durable effects of prenatal stress and 2) early life stress from apartheid-era stress on adult HPA axis function (e.g. cortisol and inflammation) and depression, and 3) to examine social support during adolescence as a potential protective factor that may reverse the long-term impacts of prenatal and early life stress. I will pursue these questions in collaboration with the Birth to Twenty study, a prospective longitudinal birth cohort study based in Soweto, South Africa since 1990. These existing data, in addition to data collected from this proposed follow-up study, serve as the basis for studying the intergenerational effects of the stressors of the apartheid regime on the mental health and biology of families living in Soweto and the potential reversibility of past, embodied trauma.

Quick Facts

Country: South Africa

Partner Institutions: University of Witwatersrand, Johannesburg, South Africa

Principal Investigator: Andrew Kim

Site-Principal Investigator: Shane Norris, PhD

 Formative Data Collection on Combination Polypill for Heart Failure with Reduced Ejection Fraction in India
India, Fall 2019

We aim to substantially simplify and improve the efficacy and safety of HF management by
shifting the treatment paradigm for patients with HFrEF from moderate dose, multi-drug therapy with frequent titration to combination polypill. We propose to investigate whether initiating treatment with a combination polypill of guideline-directed medical therapy compared to usual care will reduce the composite rate of: 1) cardiovascular disease mortality and HF hospitalizations at 12 months, as well as improve: 2) changes in HFrEF markers of disease severity (natriuretic peptide levels, left ventricular ejection fraction, NYHA class), 3) adherence to guideline-directed medical therapy, and 4) health-related quality of life as measured by a translated, validated version of the Kansas City Cardiomyopathy Questionnaire, with no increase in adverse effects, in adults discharged with acute
HFrEF in India using a phase II, multi-center, type I hybrid randomized clinical trial design. 

Quick Facts

Country: India

Partner Institutions: Centre for Chronic Disease Control, New Delhi, Delhi

Principal Investigator: Anuba Agarwal, MD, MSc
Mark Huffman, MD, MPH

Site-Principal Investigator: Dorairaj Prabhakaran, MD, DM, MSc

 Feasibility and Acceptability of Integrating Patient Reported Outcome and Experience Measures into an Outpatient Cardiology Clinic in Dar es Salaam, Tanzania

Tanzania, Fall 2019

The changing burden of disease in low and middle income countries from largely acute diseases treatment to a growing prevalence of chronic communicable (HIV) and non-communicable diseases and patients with HIV and NCD requires a change in health systems to be able to provide quality patient-centered care. To achieve this goal, the focus has expanded beyond technical quality and clinical outcomes to include experiential quality and patient reported outcome measure (PROMS) to capture these important aspects of care delivery which matters to patients. While PROMS and experiential quality measures are increasingly used in resource rich settings including the United States, their use in low and middle income countries such as Tanzania is still very rare. The study proposes to 1. adapt PROMS and experiential quality measures from validated tools for use in Tanzania and 2. test feasibility and acceptability of applying the adapted PROMS and experiential quality survey for patients with congestive heart failure (CHF) with and without HIV seen in the cardiology clinic at Muhimbili University of Health and Allied Science (MUHAS). Work will include translation and testing with cognitive debrief of selected PROMS, adaptation from existing surveys to measure experiential quality, pilot testing in a sample of 60 CHF patients, and key informant interviews with providers to measure acceptability and inform future intervention designs to broader use of measuring PROMS and experiential quality and feedback of results into routine care and quality improvement work through future grants. Because of the high proportion of CHF patients who have HIV in Tanzania, the study will also explore differences in feasibility and acceptability in patients with and without HIV. The work will build on the growing collaboration between Northwestern and MUHAS through the recently funded Patient-centered outcome research D43, and the expertise at Northwestern University in PROMS, experiential quality and HIV and quality and cardiac care at MUHAS.

Expected outcomes of the catalyzer grant will include adapted PROMS measures and experiential quality survey, formative input from patients and providers into the potential utility and implementation approach to integrate into routine care to test the impact of measurement on system improvement and patient reported outcomes as well as clinical outcomes, adherence and retention among patients with CHF and those with comorbidity of CHF and HIV.

Quick Facts

Country: Tanzania

Partner Institutions: Muhimbili University of Health and Allied Sciences

Principal Investigator: Lisa Hirschhorn, MD, MPH

Site-Principal Investigator: Pilly Chillo, MD, PhD

 Assessing Hepatitis C Virus Seroprevalence Among Pregnant Women in Nigeria
Nigeria, Fall 2019

Hepatitis C virus (HCV) infection remains an important cause of chronic liver disease for populations across the globe. While injection drug use and unsafe blood practices continue to fuel new infections worldwide, major advancements in antiviral treatment are a cause for hope in the fight against HCV. Direct-acting antivirals (DAAs) target specific proteins in the replication machinery of HCV, and these medications can be given orally, once-daily with the expected viral cure rate of >97%. DAAs came with an initial US price >$160,000 for a 12-week course of medication, but efforts to circumvent intellectual property restrictions in low- and middle-income countries have resulted in a treatment course of sofosbuvir/daclatasvir now costing between $50-300. This development has been a tremendous benefit for adults with chronic infection who were included in the initial regulatory approvals. Since availability of drug worldwide is predicated on these regulatory approvals, populations like pregnant women that fall outside the approved indication will not be able to access these drugs without additional research. We have formed this new team of collaborators with collective experience in viral hepatitis, infectious diseases in pregnancy and global health to conduct high-yield studies in special populations not represented in prior research. We have experience and established connections with global health partners that make these studies feasible. Our long-term goal is to study whether oral daclatasvir when administered to pregnant women at the approved dose for non-pregnant adults will yield drug exposures that correlate with HCV viral cure. In this study and in preparation for that work, we hypothesize that the burden of HCV disease among pregnant women in Nigeria would justify treatment with DAAs. We will test this hypothesis in the following aims: 1) Evaluate the seroprevalence and genotype distribution of HCV among pregnant women that present for prenatal care at partner sites in Nigeria; 2) Determine the prevalence of HCV core antigen (Ag) positivity from DBS samples among pregnant women who are anti-HCV positive and examine genotype distribution among those with active infection. This study will be the largest HCV seroprevalence study in Nigeria, yielding novel data on HCV core Ag testing and genotype distribution in pregnant women, an under-studied and under-represented population in HCV research worldwide. We will be well positioned to ultimately conduct a study on the pharmacokinetics of daclatasvir during pregnancy that could greatly expand access to DAAs for pregnant women with HCV, achieving HCV cure for themselves and preventing transmission to their infants.

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Country: Nigeria

Partner Institutions: Jos University Teaching Hospital
University of Ibadan

Principal Investigator: Ravi Jhaveri, MD

Site-Principal Investigator: Oche Agbaji, MBBS
Kolawole Oluseyi Akande, MBchB, MSc

 DNA Methylation in Ethnic-Specific Early Stage Breast Cancer in Mali: An Integrative and Comparative Analysis
Mali, Fall 2019

Breast cancer is the leading cancer among women and cause of cancer death among women around the world, which makes it a major and worldwide public health threat. Recent advances in the field have identified important mechanisms of DNA repair abnormalities, such as BRCA1 and 2, in genetic breast cancers. Other findings have determined the prognosis and therapeutic response of some cancers including breast cancer to drug treatments, with for instance the expression of breast carcinoma Her2 as a target guiding for therapy. Therefore, studying DNA methylation in our population offers new hope in oncology, offering the prospect of developing locally relevant new biomarkers and new therapeutic strategies. It will also improve our understanding of the etiological processes involving these markers. In this project, we will evaluate the DNA methylation profiles of tissues derived from Malian patients with early stage breast cancer. This study will provide us with a basis for genetic/epigenetic investigations to explore the role of DNA methylation in early stage breast cancer in Malian women compared to others, including ethnic-specific differences.

Quick Facts

Country: Mail

Partner Institution: University of Technique and Technology of Bamako

Principal Investigator: Brian Joyce, PhD

Site-Principal Investigator: Diakite Brehima, MD, PhD

 Automated TB Sputum Smear Microscopy for Same-Day Treatment Initiation
Mali, Fall 2019

As one of the top 10 leading causes of death worldwide, tuberculosis (TB) remains a significant public health problem. In 2017 alone, approximately 10 million new TB cases and 1.6 million TB-related deaths were reported with nearly 95% of cases occurring in low- and middle-income countries. High TB endemic settings face many obstacles in making accurate and rapid diagnosis of TB, delivering appropriate treatment, and preventing infection spread. Specifically, TB endemic countries are hampered by a lack of advanced diagnostic technology, limited numbers of skilled technicians, inadequate clinical testing infrastructure, and the high costs of diagnostic testing reagents and kits. Our team recently developed a method that uses sodium dodecyl sulfate (SDS) to improve TB SSM clarity and the safety of technicians. This technical improvement in SSM samples now makes an automated system to informatically read the slides feasible and safe. The aims of this project are 1) Develop a semi-automated smear microscopy system, 2) Evaluate the clinical proof-of-principle of this new semi-automated sputum smear microscopy system. This new assay may lead to "same day TB drug treatment initiation" in most cases, which reduces disease transmission and mortality.

Quick Facts

Country: Mail

Partner Institution: University of Technique and Technology of Bamako

Principal Investigator: Mamoudou Maiga, MD, PhD

Site-Principal Investigator: Ousmane Kodio, PhD

 Development of a Point-of-Care Diagnostic Assay for Group B Streptococcus
Nigeria, Fall 2019

Group B Streptococcus (GBS) is recognized as a leading cause of neonatal morbidity and mortality around the world. Transmission usually occurs during labor and delivery after membrane rupture. The primary risk factor for early-onset GBS infection and disease in the newborn is maternal colonization of the genitourinary and gastrointestinal tracts. Maternal antibiotic prophylaxis before and during delivery prevents transmission, but requires maternal screening before delivery, but such screening is not available in many low and middle income sites such as Jos, Nigeria. We plan to fill this gap by developing a point-of-care molecular test that can be performed when the pregnant woman presents for delivery that can be performed in locations of limited laboratory infrastructure.

Quick Facts

Country: Nigeria

Partner Institution: Jos University Teaching Hospital

Principal Investigator: Sally McFall, PhD

Site-Principal Investigator: Godwin Imade, PhD

 Controlled, Low Dosage, Intracellular Delivery of Nifurtimox for Enhanced Treatment of Chagas Disease Without Side Effects
Argentina, Fall 2019

Trypanosoma cruzi is the protozoan parasite that causes Chagas disease, an illness that affects millions in the western hemisphere from Argentina to Canada. People can become infected with T. cruzi through the bite of its reduviid bug vector or through several other means, including maternal-fetal transmission and blood transfusion. Chagas manifests as a chronic cardiomyopathy in approximately one-third of infected individuals and is the leading cause of infectious myocarditis in the world. Others develop megadisease of the esophagus or colon. The two drugs used to treat T. cruzi infection, Nifurtimox (Nfx) and Benznidazole (Bz), have been the mainstay of therapy for decades, with no significant improvement to their well-documented neurotoxicity and carcinogenicity. Chagas is thus a silent epidemic that is in dire need of more advanced treatment options. We have developed a novel nanocarrier formulation (nanoBz) that permits the delivery of parasiticidal drugs that effectively kill T. cruzi parasites at 600-fold lower concentrations than required by the current free drug formulation. Here, we propose to investigate nanocarrier formulations of Nfx (nanoNfx), both alone and in combination with Bz, in an established mouse model of Chagas disease. Nanocarrier delivery is expected to enhance Nfx intracellular delivery for improved killing of parasites as well as significantly decrease side effects in the central and peripheral nervous system.

Quick Facts

Country: Argentina

Partner Institution: National University of Cuyo

Principal Investigator: Evan Scott, PhD

Site-Principal Investigator: Patricia Silvia Romano, PhD

 MicroRNA Expression in Ethnic Specific Early Stage Breast Cancer in Mali: An Integration and Comparative Analysis
Mali, Winter 2019

Breast cancer is the leading cause of female cancers and deaths among women around the world, which makes it a major public health threat worldwide. New recent advances in this field have identified important mechanisms of DNA repair abnormalities, such as BRCA1 and 2 in genetic breast cancers. Other findings have determined the prognosis and therapeutic response of some cancers including breast cancer to drug treatments, with for instance the expression of breast carcinoma Her2 as a target guiding for therapy. Therefore, studying microRNA expressions in our population offer new hope in oncology, offering the prospect of developing locally relevant new biomarkers and new therapeutic strategy. It will also help to understand the etiological processes involving these markers. In this project, we will evaluate the microRNA (miRNA) microarray expression profiles of tissues derived from Malian patients at early breast cancer stage and we will perform a mRNA-miRNA integration assay. This study will provide us a basis for genetic/epigenetic investigations to explore the role of miRNA in early stage breast cancer in Malian women compared to Nigerians, Lebanese and others, including ethnic specific differences. 

Quick Facts

Country: Mali

Partner Institution: University of Technique and Technology of Bamako

Principal Investigator: Jun Wang, MD, PhD

Site-Principal Investigator: Brehima Diakite, MD, PhD

 A Potential Modulator of Drug Efficacy in Colon Cancer
Beruit, Winter 2019

Microbiome research has increased substantially over the past decade with recent studies revealing that the gut microbiome, an important modulator of inflammation and immunity, can significantly impact cancer risk as well as the efficacy of cancer therapy and susceptibility to its side effects. In this pilot study, we propose to evaluate the diversity of gut microbes in our population of newly diagnosed patients with stage IV colon cancer and to assess the feasibility of correlating baseline microbiome diversity in these patients having measurable lesions on CT scan with clinical response to first line chemotherapy. This pilot study will also serve to evaluate the influence of dietary patterns (Mediterranean vs Western diet) on gut microbiome and its potential effects on patients' therapy response. Accordingly, stool samples, as well as baseline demographic and clinical variables from recruited patients will be collected upon diagnosis before therapy, after three months of therapy, and at the end of therapy. A detailed food frequency questionnaire will also be recorded for every patient. 16S rRNA sequencing of microbial DNA will be performed for microbial identification. Finally, correlations between patients' microbiomes, dietary patterns and clinical responses will be analyzed. The microbiome in colorectal cancer and its effect on therapy have not been investigated in our region. The proposed study offers significant advances in more than one critical fields relating to stage IV colorectal cancer therapy treatment. It will be the first study in the region that correlates the microbiome to therapy response, while also shedding light on the effect of therapy on microbioma. Furthermore, the study will reveal the impact of dietary patterns on the microbiome diversity and its effect on colorectal cancer drug efficacy.

Quick Facts

Country: Beruit

Partner Institution: American University Beruit

Principal Investigator: Yinan Zheng, PhD

Site-Principal Investigator: Rihab Nasr, PhD

 A Multiplex Quantitative PCR Assay for HIV and Hepatitis B Virus, for Low- and Middle-Income Countries
Mali, Winter 2019

According to the WHO, 257 million people were living with chronic hepatitis B virus (HBV) in 2015 with Africa and the Western Pacific region accounting for 68% of HBV infections. HBV is an asymptomatic liver disease making its early detection difficult, leading to serious complications such as cirrhosis and hepatocellular carcinoma and death. This is a major problem for African countries with high HIV prevalence. In sub-Saharan Africa (SSA), approximately 8% of HIV-infected individuals are co-infected with HBV. Knowledge of HBV status at initiation of HIV antiretroviral therapy (ART) is essential for clinical monitoring and guiding in the selection of an initial ART regimen, as tenofovir disoproxil fumarate (TDF) should be combined with lamivudine (3TC) or emtricitabine (FTC), which suppress both HIV and HBV replication. Mali, a LMIC in West Africa has a HIV/AIDS prevalence rate of 1.1% of the general population and specific adult population groups (e.g., pregnant women, students, blood donors) have HBs Ag positive rates, ranging from 10 to 18.8%. While HIV RNA and HBV DNA quantification assays are recommended to better guide and monitor treatment, access to such quantification assays in SSA is very limited or not available in some countries. Otherwise, in Africa, HIV patients are most of the time screened only on HBs Ag. Thus, patients with occult hepatitis B (OBI) will not be detected and thus lose the opportunity for better treatment. OBI is the presence of HBV-DNA in serum and/or in liver of a patient, despite HBs Ag negativity. OBI is usually asymptomatic but its reactivation commonly occurs in immunosuppressed individuals. Therefore, there is a need to systematically investigate the presence of OBI in HIV infected patients, but also in patients treated with cancer chemotherapies. A study Dr. Fofana conducted in France showed that 3.5% subjects negative for HBs Ag had a positive HBV-DNA PCR. Importantly, among these patients, 53.8% were co-infected with HIV/HBV. In addition, other studies have shown an increased prevalence of OBI in sub-Saharan Africa in the last decade. Measurement of viral nucleic acids plays a critical role in determining the phase of infection, deciding the treatment to prescribe, and informs on the efficacy of antiviral therapy. The aim of this project is to develop and validate for the first-time a multiplex quantitative PCR (qPCR) assay for a simultaneous HBV DNA and HIV RNA quantifications that is low-cost, simple to use, and can be processed on an opensystems. Having the assay on open-systems will considerably reduce the cost, as current single assays are monopolized by few companies.

Quick Facts

Country: Mali

Partner Institution: University of Technique and Technology of Bamako

Principal Investigator: Sally McFall, PhD

Site-Principal Investigator: Djeneba Bocar Fofana, PharmD, PhD

 Evaluating Trends in HIV/HBV Co-infection Prevalence in the Era of HBV-active Antiretroviral Therapy and Novel Markers of HBV Infection in Nigeria
Nigeria, Winter 2019

In Nigeria, approximately three million people are living with HIV and AIDS and about 20 million are living with chronic HBV. Due to similar routes of transmission, the prevalence of HIV/HBV co-infection in Nigeria is high, ranging from 11-17.8%. Recently, declines in HIV/HBV co-infection prevalence in HIV programs in Africa have been reported, which some have suggested might be due to the protective effects of HBV-active ART (antiretroviral regimens that contain at least two drugs with activity against HBV) on new HBV infection. This assumes that some HBV transmission may be occurring sexually as well as horizontally during childhood and from mother to child. To date, no studies from Nigeria have evaluated trends in HIV/HBV co-infection prevalence since HBV-active ART has been introduced. In this study we will retrospectively analyze data from over 10,000 HIV-infected subjects enrolled in the Jos University Teaching Hospital APIN HIV program since 2004, assessing changes in HIV/HBV co-infection prevalence at five-yearly intervals since ART was rolled out and before and after the introduction of HBV-active ART.

In the second part of our study we plan to conduct a smaller analysis examining the effects of HBV-active ART on quantitative HBsAg (qHBsAg) levels in a cohort of HIV/HBV co-infected subjects enrolled in a longitudinal study of liver disease at the JUTH APIN clinic since 2011. These levels will be correlated with changes in HBV DNA and HIV RNA. qHBsAg measurement is a simpler and cheaper method of measuring HBV viral activity than HBV DNA and may be a more reliable measure of the efficacy and long-term durability of HBV-active ART. It can also determine whether 'functional cure' has occurred, an outcome that has been rarely studied in African HBV-infected populations. Our study will be one of the first to examine this novel marker in Nigeria.

Quick Facts

Country: Nigeria

Partner Institution: Jos University Teaching Hospital

Principal Investigator: Claudia Hawkins, MD, MPH

Site-Principal Investigator: Oche Agbaji, MBBS

 Automated, Improved and Simplified HIV Drug Resistance Assay Using Full Genome Sequencing

Mali, Winter 2018

There are an estimated 19.5 million people worldwide infected with HIV that are receiving antiretroviral therapy (ART), with Sub-Saharan Africa having the highest burden. One of the greatest problems for the HIV control programs in Africa is the development of resistance to existing ART. Monitoring people living with HIV becomes more than more difficult because of the high rate of mutations and replication of quasi-species. The current approach by Sanger Sequencing for determination of HIV drug resistance is by testing some genes identified to be responsible for drug resistance (the drugs' targets). However, the drawback with this method is its complexity, its cost, time to perform and the fragility of the equipment, all of which makes it less suitable for low-and middle-income African countries. Nanopore MinION is a new miniaturized portable and robust next generation sequencer that can characterize the full genome of viruses. We propose to use MinION to develop an assay for HIV drug resistance including a software that can automatically determine drug resistance of a wide array of HIV strains including the Circulating Recombinant Forms (CRFs). The HIV genome map is now well known but CRFs continue to evolve and hamper molecular efforts to provide assay kits based on mutations at the gene level. Our full genome strategy will eliminate this issue, as any discovery of new relevant mutations (from existing or new drugs) will only need an adaptation of the analyzing software (and not the whole kit package as it is now). This new assay will ease the protocol and enhance the turnaround time for HIV drug resistance, and facilitate precision medicine in the interest of the patient. This new assay will significantly contribute to the long-term elimination goal of this pandemic.

Quick Facts

Country: Mali

Partner Institution: University of Sciences Techniques and Technologies (USTTB), University of Bamako

Principal Investigator: Mamoudou Maiga, MD, PhD

Site-Principal Investigator: Almoustapha Maiga, PharmD, PhD

 Cross-country Evaluation of the HEALTHQUAL HIV Quality Improvement Collaborative

Zambawe, Summer 2017

This proposal has two aims designed to explore the process and interim success of adaptation, implementaion outcomes, explore the association with early intervention outcomes and provide the pilot data needed for larger grant proposals. These aims are

Aim 1: Describe the adaptation of components of the Improvement Collaborative (IC) in the African HIV treatment context and identify key contextual factors that drive their adaptation in two countries

Aim 2: Evaluate the interim success and challenges of the implementation process and outcomes of the IC including adoption, acceptability, fidelity, feasibility, and potential for sustainment and their relationship to the identified adaptations

This work will build upon the extensive existing program data collected to monitor implementation and measure the change in quality of care at sites particating in the IC. These program documents will be supplement by targeted key informant interviews of Ministry of Health IC leaders in country and US-based HEALTHQUAL leaders and coaches who are implementing the work in one country, supplemented by ethnographic observation of one three-day Learning Session, the convening event where facilities present and discuss successes and challenges. Evaluation design will follow the EPIS (Exploration, Preparation, Implementation, Sustainment) framework capturing implementation process and outcomes and the contextual factors driving adaptation and success or failure.The evaluation results will be disseminated within the program and the two countries and serve as pilot data for grant submissions to fund more in depth and summative research of adaption and implementaion of ICs inreosurce-limited settings.

Quick Facts

Country: Zambawe

Partner Institution: Ministry of Health, Zambawe

Principal Investigator: Lisa Hirschhorn, MD, MPH

Site-Principal Investigator: Tsitsi Apollo

 Menstrual Cups and Cash Transfer to Reduce Sexual and Reproductive Harm and School Dropout in Adolescent Schoolgirls in Western Kenya

Kenya, Summer 2017

This proposal requests supplemental support for work outside of the aims of the three-year cluster randomized controlled trial: Menstrual Cups and Cash Transfer to Reduce Sexual and Reproductive Harm and School Dropout in Adolescent Schoolgirls in Western Kenya. The trial is funded through the UK Joint Global Health Trials (Medical Research Council-Department for International Development-Welcome Trust) Grant #MR/N006046/1. This proposal will also provide data to support a future grant submission to support country-wide scale up through the Kenyan Ministry of Education.

This 24-month proposal will pilot and evaluate a Menstrual Hygiene Management (MHM) intervention for secondary school settings in Kenya. These supplemental funds significantly impact outcomes as they provide a dissemination and implementation aim to the RCT. All proposal processes and outputs will be shared with the Ministry of Education and the Ministry of Health National Environmental Sanitation and Hygiene Interagency Coordinating Committee (ICC). It is envisioned that the data collected and outcomes from this project will support a future grant submission for further intervention effectiveness testing (outcomes research) and contribute to the rapidly evolving body of knowledge surrounding Menstrual Hygiene Management (MHM) in low and middle-income settings.

Quick Facts

Country: Kenya

Partner Institution: Kenya Medical Training College

Principal Investigator: Leah Neubauer, EdD

Site-Principal Investigator: Kelvin Oruko

 Incidence of Hepatocellular Carcinoma in HIV and HIV/HBV infected Nigerians in the ART Era

Nigeria, Winter 2016

This will be one of the first studies to conduct a comprehensive epidemiologic study of assessing liver related clinical outcomes including HCC in HIV and HIV/HBV co-infected patients in Nigeria. A unique aspect of this study is the setting and population. Nigeria has some of the highest prevalence rates of HIV and HBV in the world, making it an ideal location to perform these types of longitudinal studies. Our study will provide important and new information the risk of HCC in both HIV and HIV/HBV co-infected individuals, identifying new areas for research in the prevention and treatment of this important non-AIDS defining malignancy. It will also be the first to implement and assess the utility of HCC screening in high-risk (cirrhotic) populations. The recruitment of an additional 300 patients to an already existing cohort who have been followed for over five years will make it one of the larger longitudinal cohorts of HIV and HIV/HBV in SSA. The cohort will provide an excellent platform for future observational and interventional studies, including longer-term natural history studies and potential therapeutic studies for HBV. It will also provide a rich source of specimens and data for retrospective analyses such as genetic and molecular studies of HIV and HBV. Results from this study will fill some of the key research gaps identified in the recently published 2015 WHO HBV prevention, care and treatment guidelines. 

Quick Facts

Country: Nigeria

Partner Institution: Jos University Teaching Hospital 

Principal Investigator: Claudia Hawkins, MD, MPH

Site-Principal Investigator: Patricia Agaba, BmBcH

 The Vaginal Microbiota: A Potential Co-factor of HPV Persistent Infection in the Progression of Cervical Intraepithelial Neoplasia

China, Winter 2016

Persistent infection with oncogenic human papillomavirus (HPV) is necessary for cervical carcinogenesis. Although evidence suggests that the vaginal microbiome may relate to the HPV infections in women with cervical intraepithelial neoplasia (CIN), the complex relationship between vaginal microbial flora, HPV infection, and CIN is not completely understood. We hypothesized that the change of microbiome diversity could be associated with persistent infection of HPV and subsequent CIN. The study population will come from Chinese women with normal cervix and CIN I, CIN II/III diagnosed by pathology of our CIN study cohort. PCR and Gene chip hybrid technology will be used to identify the HPV genotypes (15 high-risk and 6 low-risk types), and llumina MiSeq sequencing of 16S rRNA gene amplicons will be applied to detect the characterise of the vaginal microbiota in all study participants. The vaginal microbiota composition and microenvironment, and the relationship between HPV infecton and characteristics of vaginal microbiome in the evolution of CIN will be analyzed.

Quick Facts

Country: China

Partner Institution: Shanxi Medical University 

Principal Investigator: Lifang Hou, MD, PhD

Site-Principal Investigator: Jintao Wang, PhD

 Multiplex-PCR for Differentiation of Mycobacterium Avium from Mycobacterium Tuberculosis Complex

Mali, Winter 2016

Tuberculosis (TB) remains a public health problem in developing countries and recent reports also indicate a constant increase in the prevalence of nontuberculous mycobacteria (NTM) in those areas that are traditionally endemic for TB. Infections by NTMs are clinically undistinguishable from tuberculosis. This complicates the management of patients as sputum smear microscopy, the most widely used diagnostic tool for TB cannot differentiate mycobacterial species. We found in Mali that 18% of patients considered being TB chronic cases that were empirically treated as multidrug-resistant TB (MDR-TB) cases were in fact infected by NTM, most of which were M. avium (73%). In addition, we found that only 36% of the "chronic cases" treated as MDR-TB were true MDR-TB cases. Without an appropriate diagnostic, these patients receive more than 3 years of incorrect, expensive and potentially toxic medications. An effective treatment is available for M. avium, therefore it's not acceptable to leave this continuously growing population undiagnosed and untreated. The ongoing broad implementation of Xpert MTB/RIF assay and other molecular tools recommended by World Health Organization to replace sputum smear microscopy contribute to more accurate and sensitive TB diagnosis, but does not address the problem of NTM infection. In addition to limited resource settings, NTM infections are also prevalent in most developed countries including United States, especially in HIV infected individuals. New diagnostic tools to differentiate M. avium infection from M. tuberculosis are thus desperately needed and will significantly improve patients' management worldwide. In this application, we propose to build upon existing scientific infrastructures at Northwestern Center for Global Health (CGH) and Center for Innovation in Global Health Technologies (CIGHT), as well as leverage our ongoing studies through CGH at the Mali University of Sciences, Techniques and Technologies of Bamako (USTTB)'s SEREFO Laboratory (R01 study, Mali02 study, and D43 training program, PIs: S. Diallo and R. Murphy) to develop a new diagnostic test that will differentiate M. tuberculous complex (MTBC) from the treatable and the most common NTM, M. avium complex (MAC).

Quick Facts

Country: Mali

Partner Institution:  Universite des Sciences, des Techniques et des Technologies de Bamako

Principal Investigator: Mamoudou Maiga, PhD, MD, MSc

Site-Principal Investigator: Souleymane Diallo, MD

 Autopsy Assessment of Prostate Cancer Prevalence Across Nigeria

Nigeria, Winter 2016

Prostate cancer (PCa) is the most commonly diagnosed cancer in men worldwide and the most common cancer in Nigerian men despite the lack of PSA screening.[1] The age-adjusted death rate for PCa has decreased from 2005-2015 worldwide but the incidence and death rates actually increased for sub-Saharan Africa.[1-3] The epidemiology of latent PCa and the benefits of screening are unknown in Nigeria as prior studies did not examine the entire prostate.[11-12] Men of Nigerian ancestry, including African American (AA) men, are 1.6 times more likely to be diagnosed with PCa in the US compared to European Americans (EA).[4] AAs are also 2.5 times more likely to die from PCa, and harbor more aggressive disease at radical prostatectomy when they have similar biopsy findings as White men.[14] Given the genetic ancestral ties, this has implications for Nigerians.[4,5] Chromosome 8q24 is the mostly associated risk locus for PCa in the US and Europe. We showed that chromosome 8q24 risk SNPs were more common in West African (WA) men relative to studies in AA and EA men; AA men SNP frequencies were similar but less than the 8q24 polymorphism frequencies seen in WA men.[5] We also identified new PCa risk variants in chromosome 8q24 in Nigerians which were replicated in Ghanaian and Ugandan men.[6] Shorter CAG repeats in the androgen receptor gene (AR) have been associated with PCa risk and are more common in WAs and AAs relative to EAs.[7] This is consistent with the fact that AAs are genetically about 80% WA and 20% European.[8,9] Taken together, Nigerian men may have a higher incidence of PCa than AA men but aren’t screened thereby limiting detection. Limitations in health infrastructure, urologists and radiation oncologists impede the feasibility of PCa screening programs in Nigeria. Because public support in Nigerian for cancer registries has increased, elucidating the epidemiology of PCa and aggressive PCa might make targeted screening for aggressive PCa a public health priority. Our overarching hypothesis is that Nigerian men have a higher age-adjusted prevalence of PCa and aggressive PCa relative to autopsy studies from the US.

Quick Facts

Country: Nigeria

Partner Institution: Jos University Teaching Hospital 

Principal Investigator: Adam Murphy, MD, MSCI

Site-Principal Investigator: Ayuba Madachi Dauda, BmBcH

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