Global Health Awarded Catalyzers

Lymphatic filariasis (LF) is a devasting disease affecting more than 120 million people, a disproportionate number of whom live in low-income rural communities in West Africa and Southeast Asia. It is caused by repeated infection with microfilaria, most commonly from Wuchereria bancrofti, which migrate into the lymphatic vessels and can persist in the adult form for more than eight years. The majority of people who are exposed do not become infected, and the majority of those infected manifest few to no symptoms, raising questions about the role of the host immune response and bacterial microenvironment in the development and progression of disease. Recent studies have demonstrated that microbiome-immune interactions can influence the development and chronicity of chronic wounds, including in LF. Moreover, a mounting body of evidence suggests that dysbiosis of affected skin contributes to the progression of LF. Yet there have not been any studies to date that fully characterize the cutaneous microbial environment of patients affected by LF. Similarly, the local protein expression profile of lesional skin has yet to be characterized, although proteomic data on chronic and nonhealing wounds from other causes have shown significant differences in the expression profile of multiple proteins that play a role in skin healing.

To address these critical gaps, the multidisciplinary, international research team uses high-throughput molecular sequencing to investigate the cutaneous microbiome of a cohort of patients with lymphatic filariasis, as well as performing proteomic analysis of the affected skin of LF patients. This cohort study recruits patients from 20 endemic communities in the Ahanta West and Nzema East Districts of western coastal Ghana, building on the years-long ties that the Ghanian research team has established with patients and community members. During the 3-4 month fieldwork period, the team collects skin swabs, wound swabs, tape strips, stool samples, skin biopsy samples, and whole blood samples from affected individuals and from healthy controls in these communities. Survey data is collected from all participants to determine demographics, medical co-morbidities, treatment history, antibiotic exposures, and other factors that may prove to influence disease progression. Samples will be transported to the laboratory at KNUST and stored at -80oC for future use. The establishment of this long-term biobank in the Kumasi Centre for Collaborative Research into Tropical Medicine (KCCR) will pave the way for future collaborations between the Northwestern and KNUST research teams into the pathophysiology of the progression of lymphatic filariasis, while building research capacity at KNUST. A subset of the skin swabs and tape strips will be shipped to Northwestern for sequencing and subsequent analysis, providing proof-of-concept results that will be used to apply for subsequent grants, grounding further investigations that will make use of the materials collected in the biobank.

The microbial and immune landscape of LF-affected skin is unknown and vitally important for understanding the relationship between microbiota shifts and disease progression, understandings which may ultimately guide clinical management to prevent and treat progression to the severe and irreversible sequelae of lymphatic filariasis.

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Country: Ghana

Principal Investigator: Xiaolong (Alan) Zhou and Amy Paller

Partner Institutions: KNUST

Site-Principal Investigator(s): Leonardo K. Amekudzi

Vital signs monitoring is critical for the detection of postoperative complications In Low- and Middle-
Income Countries (LMICs). Intermittent manual vital signs monitoring is ineffective to detect
complications in a timely manner (1-3), mainly due to the inability to frequently monitor and interpret
vital signs or inadequate recording of vital signs.(2, 4-6) The current bedside vital sign monitors provide
much needed continuous vital sign data; however, a number of factors make these monitors
unsustainable and ineffective in resource-limited settings.(7) The bedside monitors are expensive, and
their service and maintenance requirements generally far exceed local resources. Together with
voltage instability, these factors contribute to short lifespan of conventional monitoring equipment.
Additionally, human resource factors make conventional monitoring devices less than ideal due to the
large amount of time required to take patient vitals and record them manually. We believe that
Bluetooth-based wearable physiology monitors, such as Fitbit or Xiaomi bands, connected to central
monitoring stations may be able to overcome the limitations of currently used vital sign monitors and
improve the care of patients presenting to the hospital with trauma or recovering after surgery.
In-hospital vital signs monitoring currently requires a large amount of personnel time or expensive
monitoring devices that malfunction frequently. This creates difficulties monitoring trauma patients and
post-surgical patients who can deteriorate rapidly and contributes to the increased rates of morbidity
and mortality of patients in low resource settings as compared to those in high resource settings.
Consumer wearable devices (CWDs) have incorporated sensors that are comparable to clinical grade
bedside monitors.(8) The use of CWDs has increased over the last few years in adults and children.(9)
CWDs can transmit data in near real-time to a smart phone using Bluetooth technology, and then to a
cloud computing service that can be shared with a clinical team. With these capabilities, CWDs such
as the Fitbit and the Xiaomi band have great potential as a wireless monitoring system.

Our study group has received Ghana Food and Drugs Authority approval for use of CWDs for medical
research purposes and is the only group to have ever done so. This unique approval contributes to
ongoing research efforts and relationships within Ghana that will further Northwestern global health
research efforts within the country.

Quick Facts

Country: Ghana

Principal Investigator: Fizan Abdullah

Partner Institutions: Korie-Bu Teaching Hospital/Ghana

Site-Principal Investigator(s): Dr. William Appeadu-Mensah

In Nigeria, approximately 100,000 new cancer cases occur every year with limited options for treatment. When treatment is available, outcomes remain poor due to delayed presentation and treatment resulting from minimal insurance coverage and high out-of-pocket expenditures. In sub-Saharan Africa, it is estimated that between 77-94% of cancer patients experience financial catastrophe, defined as health expenditure that exceeds 10% of the household expenditure or 20% of the household income. Financial navigation programs, which have been implemented as a standard of care in the United States, show promise in improving access to cancer care and treatment adherence. However, there is sparse research on the effectiveness of these studies in resource-constrained settings like Nigeria.

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Country: Nigeria

Principal Investigator: Juliet Lumati

Partner Institutions: Lakeshore Cancer Center/Nigeria, Lagos

Site-Principal Investigator(s): Chineye Iwuji

Coronavirus Disease 2019 (COVID-19) is caused by the severe acute respiratory disease coronavirus type 2 (SARS-CoV-2). Since the beginning of the pandemic there have been more than 774 million cases confirmed cases worldwide and over 7 million deaths (1 ). In Colombia, there have been at least 6.3 million confirmed cases and more than 142,000 deaths (2). Even though 71, 7% of the population is fully vaccinated, there are still ~ 1000 new cases/month. This is likely and an underestimate since most people get diagnosed with home antigen tests that are not reported or tallied. While some patients suffer from severe COVID-19 pneumonia often requiring mechanical ventilation in the ICU, approximately 90% of SARS-CoV-2-infected individuals have only mild initial respiratory symptoms and do not require hospitalization for pneumonia or hypoxemia. However, many present with symptoms persisting > 4 weeks after COVID-19 onset which are now called Long COVID or "post-acute sequelae of SARS-CoV-2 infection" (PASC). Dr. Koralnik and colleagues have evaluated >2350 patients with neurologic manifestations of Long COVID at the Neuro­COVID-19 clinic at Northwestern Medicine. Among those, >80 % complain of brain fog and >50% have evidence of moderate or severe cognitive impairment on standardized testing. Despite the frequent occurrence of "brain fog" and cognitive symptoms among patients with Long COVID, therapeutic interventions are limited. Their preliminary data suggest that cognitive rehabilitation is an effective therapeutic intervention in some of those patients.

Objective. This study aims to evaluate the outcomes of cognitive rehabilitation in Long COVID patients with cognitive dysfunction in Medellin, Colombia, and explore biomarkers and clinical variables associated with the outcome. Methods. This is a non-randomized, interventional study with a single-arm pre-post design. The study will take place at the CES University outpatient facilities in Medellin, Colombia. Patient intervention and follow-up will be performed over a one year period after initiation of the award. Patients with Long COVID with cognitive dysfunction (score< 1.0 SD in at least one cognitive domain (processing speed, attention, executive function, working memory) of the NIH toolbox cognitive tests will be included. Patients will receive a Spanish adaptation of the Shirley Ryan Ability Lab's protocol for cognitive rehabilitation of Long COVID brain fog. Primary outcomes will include 1) Objective cognitive function measured with the NIH toolbox, and 2) Subjective impression of Cognition, Fatigue, Anxiety, Depression, and Sleep disturbance measured with Patient Reported Outcome Measure Information System (PROMIS). In addition, blood will be collected for analysis of Long COVID biomarkers in the US. Mean change and associated factors will be analyzed with the Generalized Linear Model.

Impact and expected results. We expect to define the potential benefits of evidence-based cognitive rehabilitation for Spanish-speaking Long COVID patients with cognitive dysfunction in a middle-income economy country of Latin America. Additionally, we expect to identify biomarkers and clinical characteristics that may predict response to

Quick Facts

Country: Colombia

Principal Investigator: Igor Koralnik

Partner Institutions: Universidad CES/Medellin, Colombia

Site-Principal Investigator(s): Carolina Hurtado

Lung cancer is a major global cause of death, and studies have shown a significant connection between tuberculosis (TB) and an increased risk of developing lung cancer. The aim of this research is to improve early detection and prevention of lung cancer by identifying new epigenetic biomarkers and understanding how lung cancer and TB are linked. In low- and middle-income countries like Mali, diagnosing lung cancer is challenging, often leading to late diagnoses because of similar symptoms with TB. The cost of CT scans makes them less accessible, so invasive lung biopsies are common but have limited accuracy. Epigenetics, a key player in cancer development, offers potential diagnostic and personalized treatment opportunities. To make these tools widely available, comprehensive validation is needed. Africans and African Americans have a higher lung cancer rate despite lower smoking rates, suggesting unique factors. Previous TB infections also increase lung cancer risk. Analyzing the epigenetics of Malian lung cancer in the context of TB could reveal new genetic and epigenetic biomarkers. Our specific aims are: (1) Identify epigenetic biomarkers in Malian patients with lung cancer (LC) without previous TB disease compared to healthy participants, (2) Examine the epigenetic biomarkers in TB-associated LC.

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Country: Mali

Principal Investigator: Mamoudou Maiga

Partner Institutions: Mali: USTTB

Site-Principal Investigator(s): Brehima Diakite

The global healthcare workforce crisis in Low- and Middle-Income Countries (LMICs) has been widely documented and is becoming more urgent across and within countries. Several factors underlying this crisis include economic constraints, difficult working conditions, limited incentives, migration, and scarce educational and training opportunities (1). In response to the urgent need for healthcare workers in ESWA regions, where patient populations are disproportionately impacted by disease burden, it is essential to implement educational best practices to maximize the impact of education and to build a capable workforce. This will equip the next generation of healthcare providers with the necessary knowledge, skills and motivation to effectively provide high-quality healthcare (2). Departments of Medical Education (DMEs) and Departments of Health Professions Education (DHPEs) can centralize efforts to provide high-quality teaching and learning (3). Large-scale global health initiatives like the Medical Education Partnership Initiative (MEPI; 4) and faculty development in medical education through groups like the Foundation for Advancement of International Medical Education and Research (FAIMER; 5) have led to a growth in DMEs across medical schools in Africa. DMEs and DHPEs may be referred to as units, departments, offices, or centers within their respective institutions. Wherever applicable, we use DMEs and DHPEs interchangeably, defining them broadly as departments that support medical education, research, teaching, program evaluation, and educational technologies (6).

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Principal Investigator: Ashti Doobay-Persaud

Partner Institutions: Makerere University

Site-Principal Investigator(s): Dr. Kiguli-Malwadde

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.

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Country: Tanzania

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

Principal Investigator: Claudia Hawkins, MD

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Country: Nigeria

Principal Investigator: Gregg Montalto

Partner Institutions: Nigeria: College of Medicine, University of Lagos

Site-Principal Investigator(s): David A. Oke

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Country: Tanzania

Principal Investigator: Colleen Fant

Site-Principal Investigator(s): Shahzmah Suleman

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.

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Country: Peru

Partner Institutions: Universidad Peruana Cayetano Heredia, Lima, Peru

Principal Investigator: Roxanna Garcia, MD, MS, MPH

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Country: Nigeria

Partner Institutions: University of Ibadan, Nigeria 

Principal Investigator: Yinan Zheng

Site Principal Investigator(s): Imran Morhason-Bello

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Country: Nigeria

Partner Institutions: University of Ibadan, Nigeria

Principal Investigator: Brian Joyce

Site Principal Investigator(s): Adegboyega Akere

Non-communicable diseases (NCDs) are the leading cause of death worldwide, with early 80% of the deaths in low- and middle-income countries (LMIC). Primary care health systems of LMICs, historically oriented to infectious disease and maternal and child health are not well designed to integrate NCD care. We propose a new collaboration between Northwestern, the Global Alliance for Chronic Diseases (GACD) Research Network and the Bill and MEdlinda Gates Foundation-funded Primary health care research consortium (PHCRC) to leverage existing funded studies of models to integrate NCDs into primary care in LMICs.

The main 3 research aims are:
1. To identify key components of PHC service delivery models for NCDs in LMIC settings from the work funded by the GACD.
2. To identify what has been learnt by the GACD on how to implement these components.
3. To describe the contextual factors that influence the service delivery models and implementation strategies and outcomes.

Methods: This study will use a convergent, parallel mixed methods design for simultaneous collection of qualitative and review of quantitative data, followed by convergence and subsequent interpretation of the data. The study will include the following steps:
1. Establish a global working group of PHC researchers within the GACD research network. A scoping review of all GACD funded projects will be conducted using a structured template to identify relevant projects. The PIs of the relevant projects will be contacted and asked to participate and join the working group.
2. Develop protocol and data collection tools. The PIs will develop a protocol and data collection tools including: self-administered survey to collect details on the funded research and outcomes,and key informant interview (KII) guides to explore emerging implementation and effectiveness evidence on the integrated NCD PHC service delivery model.
3. The survey will be shared with eligible GACD grant recipients. The research fellow will also conduct semi-structured interviews with the GACD research teams via telephone or zoom and perform the document analysis.
4. Descriptive statistics will be useed to describe the components and outcomes of the different models from the survey.

Interviews will be transcribed and coded using NVivo software. Using a deductive and inductive approach, we will extract strategies, outcomes and contextual barriers and facilitators from each project. We will then use convergent mixed-methods to understand the relationship between model characteristics, implementation strategies and outcomes as well as the contextual factors to identify cross-cutting models and strategies which were associated with success integrating NCD care into PC. The 3 main questions are:
1. What are optimal service delivery models for integrated NCD care in PC in different settings?
2. How to implement the models?
3. What were the clinical and implementation outcomes?
4. What were the contextual factors influencing the model and outcomes?

Findings will be disseminated through the GACD, PHCRC and Northwestern University and published in a scientific journal. Follow-up research questions will be collaboratively prioritized to develop grants including GACD partners, the PHCRC and Northwestern to further the research replicating the models at scale.

Quick Facts

Partner Institutions: The Global Alliance for Chronic Diseases (GACD) Research Network & the Bill and Melinda Gates Foundation funded Primary Healthcare Research Consortium (PHCRC)

Principal Investigator: Lisa Hirschhorn, MD, MPH

Site Principal Investigator(s): Devarsetty Praveen, MD and Bob Mash, PhD

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Principal Investigator: Judd Hultquist

Site-Principal Investigator(s):Babafemi Taiwo (iCARE Nigeria team)

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Principal Investigator: Namratha Kandula

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Principal Investigator: Anita Mulye

Partner Principal Investigator: Nicholas Akgulian

Hypertension is a major public health problem due to its high prevalence and major risk factor for
cardiovascular diseases. Based on a systolic BP (SBP) ≥ 140 mmHg and/or diastolic BP (DBP) ≥ 90 mmHg,
hypertension prevalence estimates among Malian adults, range from 21.1% and 24.7%, in rural and urban
settings, respectively. However, this prevalence may be underestimated as the disease burden is poorly
assessed in Mali. Awareness, treatment, and control rates are also all estimated to be very low. Cardiologists are only available in tertiary hospitals in larger cities in Mali with most diagnosed cases being monitored by primary care physicians, especially in rural settings with limited or no cardiologists. In this pilot study, we propose to (1) Characterize and compare hypertension service availability, readiness, diagnosis, treatment, and control rates in two different healthcare settings in Mali: two primary care centers and one tertiary hospital (Point-G Hospital); (2) Test the feasibility of a short-term (7-day) home BP monitoring program, using a semi-automated oscillometric device in patients receiving care at two primary care centers and one tertiary hospital; and (3) Assess the feasibility, acceptability, and short-term effect of lowering SBP over 1-month, using a Community Health Worker (CHW) led team-based care with home BP monitoring compared with usual care at two primary care centers and one tertiary hospital.

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Country: Mali

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

Principal Investigator: Mamoudou Maiga, MD

Site-Principal Investigator(s): Souleymane Coulibaly

The Astana declaration reaffirmed the role of Primary Health Care (PHC) for population health. In response the WHO developed guidelines for Age-Friendly Health Services (AFHS) at PHC centers to improve care for older patients. We will measure AFHS implementation and barriers and facilitators in Lagos, Nigeria using a mixed-methods study in 15 of the 57 flagship PHCs. Results will be used to to develop and test interventions to improve care readiness and delivery for older people in Nigeria.

Population ageing is occurring globally but much more rapidly in low- and middle income countries. The burden of non-communicable chronic diseases increases with age and the focus now is on interventions that slow their onset and that promote healthy ageing. The 2018 Astana declaration reaffirms that the Primary Health Care (PHC) approach is critical to both ensuring that everyone everywhere is able to enjoy the highest attainable standard of health and achieving the global goals of Universal Health Coverage (UHC) and health-related Sustainable Development Goals (SDG). In this regard, the World Health Organization developed a guideline for providing Age-Friendly Health Services (AFHS) at the primary health care centers to improve primary health care responses about the specific needs of their older patients.

This research is aimed at assessing the level of implementation of the WHO framework for age friendly PHCs and to determine the barriers and facilitators to implementation.

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Country: Nigeria

Partner Institutions: Lagos University Teaching Hospital & the College of Medicine, University of Lagos

Principal Investigator: Lisa Hirschhorn, MD, MPH

Site-Principal Investigator(s):
Adedoyin Oyeyimika Ogunyemi, MPH, MA, Lagos University Teaching Hospital
Mobolanle Rasheedat Balogun, MPH, College of Medicine, University of Lagos

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.

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Country: Mali and Guinea

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

Principal Investigator: Mamoudou Maiga, MD, PhD

Urogenital fistula, an abnormal communication between the vagina and the urinary tract, while rare in developed countries, is prevalent in developing countries as a result of obstructed labor and inadequate access to prenatal and intrapartum health care. In Rwanda when fistula occurs the women are often ostracized from their villages and families. Due to a lack of trained physicians in the country, surgical missions with experts in fistula repair have been going to Rwanda for many years. Our recently published data shows an increase in iatrogenic fistula in Rwandan women, and regional variation in fistula occurrence is suspected but not measured. Current training efforts for Caesarian section occur mainly in Kibagabaga hospital in Kigali. If other regions show increased rate of fistula then our preventative skills training can be targeted to have maximal impact to decrease fistula occurrence.

Methods: We aim to review the pre-operative evaluation and surgical outcomes of all women who underwent repair of urogenital fistula during surgical missions run by the International Organization for Women and Development (IOWD) in Kigali, Rwanda between April 1, 2010 and April 1, 2018 with the aim identifying regional variation of fistula occurrence and directing our skills training intervention of local practitioners. In addition, the rates of iatrogenic fistula at the time of to caesarian delivery has increased in the past 10 years due to increased access to surgical care. In a recent publication, we have shown that the rates of iatrogenic fistula have statistically increased in the past 7 years. We aim to assess the regional variation in iatrogenic fistula throughout the country with the goal of targeting our existing preventative surgical curriculum to those areas with the highest rates, with the ultimate goal to decrease the overall rate of genitourinary fistula in Rwanda. This includes both online and skills lab training which can be focused in areas in which they can have the greatest sustainable impact. Prospective assessment of regional rates will also allow re-targeting educational efforts in an ongoing manner. In addition, there is currently no certification for female pelvic medicine training in Africa. Dr. Kielb is a member of a United States/African consortium of 8 physicians developing a skills training and exam. A fistula trainer is part of this curriculum and will be utilized before and during each mission to provide sustainable local capacity building to treat less complex fistulas between IOWD missions, and teach local professionals to characterize
fistulas to identify those best treated by an experienced mission team.

In addition we plan to optimize the pre-operative evaluation of these complex patients and assess whether intraoperative cystoscopy altered the surgical plan. It has been our practice to routinely assess ureteral patency and fistula location by cystoscopy prior to or at the time of each fistula repair, regardless of whether a vaginal or abdominal approach is planned. This is not routinely done at other fistula clinics. Another aim is to critically evaluate our surgical outcomes to better understand where further improvements in the management of urogenital fistula should be directed. We will also evaluate the number of patients deemed in operable by our surgical team, and evaluate how many patients continue to return to one of our fistula missions despite this and why. We will also evaluate whether those deemed in operable by our team underwent surgery elsewhere, and if the repair was successful.

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Country: Rwanda

Partner Institutions: The International Organization for Women and Development (IOWD), Kigali, Rwanda

Principal Investigator: Stephanie Kielb, MD

Malaria epidemiology is changing in response to successfully targeting the most vulnerable populations with effective interventions. Since 2012, seasonal malaria chemo prevention (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 cost effectiveness 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 population wide 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 chemo prevention 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.

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Country: Ghana

Partner Institutions: University of Ghana, Ghana

Principal Investigator: Jaline Gerardin, PhD

Site-Principal Investigator(s): Yaw Afrane, PhD and Linda Amoah, PhD

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(s): Oche Agbaji, MBBS & Kolawole Oluseyi Akande, MBchB, MSc

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.

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Country: Nigeria

Partner Institution: Jos University Teaching Hospital

Principal Investigator: Sally McFall, PhD

Site-Principal Investigator: Godwin Imade, PhD

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 utilized 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 utilized 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.

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Country: Nigeria

Partner Institutions: University of Ibadan, Nigeria

Principal Investigator: Matthew Glucksberg, PhD

Site-Principal Investigator: Akinwale Coker

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 organizations, as well as such places of public gatherings like schools, markets, places of worship, malls, stadia and so on.

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Country: Nigeria

Partner Institutions: University of Ibadan, Nigeria

Principal Investigator: Mamoudou Maiga, MD, PhD

Site-Principal Investigator: Akinwale Coker

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.

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Country: Togo

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

Principal Investigator: Lisa Hirschhorn, MD, MPH

Site-Principal Investigator: Kevin Fiori, MD

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 high dimensional 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.

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Country: Brazil

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

Principal Investigator: Matthew Feinstein, MD

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.

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Country: Mali

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

Principal Investigator: Mamoudou Maiga, MD, PhD

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 immuno-suppressed 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 open systems. Having the assay on open-systems will considerably reduce the cost, as current single assays are monopolized by few companies.

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Country: Mali

Partner Institution: University of Technique and Technology of Bamako

Principal Investigator: Sally McFall, PhD

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

While it is increasingly understood that childhood trauma exposure raises a child's future risk of adult depression and other mental illnesses, new data suggest that positive social experiences such as social support, particularly during adolescence, can reverse the programming effects of early adversity on stress physiological systems. Although pregnancy 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 that coordinate 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.

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Country: South Africa

Partner Institutions: University of Witwatersrand, Johannesburg, South Africa

Principal Investigator: Andrew Kim

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. 

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Country: Mali

Partner Institution: University of Technique and Technology of Bamako

Principal Investigator: Jun Wang, MD, PhD

Site-Principal Investigator: Brehima Diakite, MD, PhD

Public health measures, specifically physical distancing policies, have been implemented throughout the world, playing a major role nationally, regionally, and locally during the COVID-19 global pandemic. Human mobility data has been adopted by the public health sector as a potential novel and unique data source to guide policies and response planning. The COVID-19 Mobility Data Network (CMDN) facilitated the responsible and meaningful use of widely available human mobility data by policymakers around the world Over 150 researchers from around the world joined the network, contributing their scientific and analytic skills to develop methods necessary to transform these new data sources to meet the needs of their government counterparts. Both researchers and policymakers assumed that collecting, analyzing, and sharing human mobility data would provide insights to help both policymakers and response planners guide their activities to mitigate the human, economic and social impacts of COVID-19. However, the evidence that human mobility data were operationally useful and provided added value for public health response planners remains largely unknown. Current research and scientific inquiry on the impact of using human mobility data for decision-making during disasters is largely quantitative. Qualitative evidence is needed to
determine whether or not these data were useful and provided added value, and how to improve the use of novel data sources in future disasters. This proposal will advance the understanding of how researchers, policymakers, and response planners used human mobility data during the COVID-19 pandemic by leveraging rigorous qualitative methods based upon grounded theory and constant comparative methods. The research will use narrative data from over 41 interviews from around the world that reflect near real-time perceptions of use during the pandemic. The specific aims of this project are to 1) investigate how public health practitioners, response planners, and researchers used human mobility data at the local,
regional and national levels, and 2) learn the socio-behavioral elements that would make human mobility data more useful and valuable for public health practitioners, response planners, and researchers in future disaster and emergency settings. At the completion of the study, we will have qualitative evidence on how a global network of researchers, policymakers and response planners used human mobility data during the COVID-19 pandemic. The result of this project will provide preliminary work for larger research studies that will investigate broader qualitative themes of how data is used during disasters with a focus on the safe and equitable use of novel data to enhance human health during disasters.

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Partner Institutions: CrisisReady, Harvard University & Direct Relief

Principal Investigator: Jennifer Chan, MD, MPH, FACEP

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.

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Country: Nigeria

Partner Institutions: University of Abuja, Nigeria

Principal Investigator: Mark Huffman, MD, MPH

Site-Principal Investigator: Dike Ojji, PhD

The goal of this research program is to describe, understand, and improve developmental trajectories of cardiovascular health (CVH) beginning in childhood, in diverse populations emphasizing LMICs. CVH is defined as the sum of healthy diet, physical activity and body weight, avoidance of tobacco, and favorable blood pressure, cholesterol, and glucose, together represented by the composite CVH score. The ideal trajectory of CVH – conferring longevity, optimum quality of life, and multiple long-term health benefits – must be promoted and preserved from early life to attain the global aspiration of Health for All.

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Country: Nigeria

Partner Institutions: South Africa, Argentina

Principal Investigator: Darwin Labarthe

Elevated blood pressure (BP) is one of the leading modifiable risk factors for cardiovascular disease (CVD) morbidity and mortality in both high-income countries, such as the United States, as well as low- and middle-income countries. Approximately 1.4 billion adults have elevated BP globally, including as many as 44% of adults in Nigeria, the most populous country in sub-Saharan Africa. Nigeria has set a national goal of reducing the risk of premature mortality from non-communicable diseases (NCDs) by 1/3 by 2030 in accordance with the United Nations Sustainable Development Goals (Target 3.4). However, this goal will not be achieved without much better BP control in Nigeria, and other low- and middle-income countries.

Based on the burden of disease, need for strengthening retention, and existing infrastructure, we propose a research study that uses systems modeling for improving retention in hypertension care in primary care settings. This proposal will be embedded within the HTN Program in Nigeria, and the research findings will provide quantitative and qualitative data on facilitators, barriers, strategies, and context of system-based approaches to improve retention in Nigeria as an example for resource-limited settings.

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Country: Nigeria

Partner Institutions: College of Health Sciences, University of Abuja

Principal Investigator: Lisa Hirschhorn, MD, MPH

Site-Principal Investigator(s): Dike Ojji, PhD

Tuberculosis (TB) affects more men than women around the world. However, the underlying mechanism of sex-based difference in TB susceptibility and treatment outcomes is unknown. We have developed a cohort of men and women with TB (cases) and house-hold matched controls without TB in Mali, a West African country with significant TB rates. Our central hypothesis is that men and women have a differential immune response to TB that is mediated by sex steroid hormones, notably testosterone and estradiol, leading to differences in treatment outcomes. We are applying for the Institute for Global Health Catalyzer Award to test this hypothesis, using archived samples from our established cohort. We propose to address two specific aims: (1) compare the frequency and absolute count of MTB-specific CD4+ T lymphocytes in men and women before and after anti-TB treatment relative to the control groups and (2) correlate changes in sex hormone levels during anti-TB treatment with the frequency and absolute count of MTB-specific CD4+ T lymphocytes. The study will be conducted in the state-of-the-art laboratory facilities at the University Clinical Research Center (UCRC), in Bamako, Mali. This project will yield new insights into immune responses to TB and provide essential preliminary data for further translational research to be investigated in an R-type application to the NIH. The project leverages the longstanding research and training collaboration between the UCRC of the University of Sciences, Techniques, and Technologies of Bamako (USTTB) in Mali and the Institute for Global Health (IGH) at Northwestern University.

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Country: Mali

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

Principal Investigator: Robert Murphy, MD

Site-Principal Investigator: Djeneba Dabitao, PhD

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.

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Country: Nepal

Partner Institutions: Paropakar Maternity Hospital and Medical College, Nepal

Principal Investigator: Janine Khan, MD

Site-Principal Investigator: Sunil Manandhar, MD

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 breast milk 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 breast milk 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.

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Country: Uganda

Partner Institutions: Makerere University College of Health Sciences, Uganda

Principal Investigator: Monica Langer, MD

Site-Principal Investigator: Phyllis Kisa, MD

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 super spreaders. 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.

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Country: South Africa

Partner Institutions: Stellenbosch University, South Africa

Principal Investigator: Christine Zelano, PhD

Site-Principal Investigator: Grant Theron, PhD

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.

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Country: Nigeria

Partner Institutions: University of Ibadan, Nigeria

Principal Investigator: Ramon Lorenzo, PhD

Site-Principal Investigator: Dr. Adewumi

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 seroconvert using a dried blood spot based assay.

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Country: Nigeria

Partner Institutions: University of Abuja, Nigeria

Principal Investigator: Mark Huffman, MD, MPH

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.

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Country: Nigeria

Partner Institutions:
University of Ibadan, Nigeria
Defense Reference Laboratory, Health Implementation Program, Ministry of Defense, 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

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.

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Country: Tanzania

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

Principal Investigator: Claudia Hawkins, MD, MPH

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. 

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Country: India

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

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

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.

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Country: Tanzania

Partner Institutions: Muhimbili University of Health and Allied Sciences

Principal Investigator: Lisa Hirschhorn, MD, MPH

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.

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Country: Mail

Partner Institution: University of Technique and Technology of Bamako

Principal Investigator: Brian Joyce, PhD

Site-Principal Investigator: Diakite Brehima, MD, PhD

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.

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Country: Mail

Partner Institution: University of Technique and Technology of Bamako

Principal Investigator: Mamoudou Maiga, MD, PhD

Site-Principal Investigator: Ousmane Kodio, PhD

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Country: Argentina

Partner Institution: National University of Cuyo

Principal Investigator: Evan Scott, PhD

Site-Principal Investigator: Patricia Silvia Romano, PhD

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.

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Country: Beruit

Partner Institution: American University Beruit

Principal Investigator: Yinan Zheng, PhD

Site-Principal Investigator: Rihab Nasr, PhD

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.

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Country: Nigeria

Partner Institution: Jos University Teaching Hospital

Principal Investigator: Claudia Hawkins, MD, MPH

Site-Principal Investigator: Oche Agbaji, MBBS

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.

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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

This proposal has two aims designed to explore the process and interim success of adaptation, implementation 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 participating 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 adaptation and implementation of ICs inreosurce-limited settings.

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Country: Zimbabwe

Partner Institution: Ministry of Health, Zimbabwe

Principal Investigator: Lisa Hirschhorn, MD, MPH

Site-Principal Investigator: Tsitsi Apollo

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.

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Country: Kenya

Partner Institution: Kenya Medical Training College

Principal Investigator: Leah Neubauer, EdD

Site-Principal Investigator: Kelvin Oruko

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. 

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Country: Nigeria

Partner Institution: Jos University Teaching Hospital 

Principal Investigator: Claudia Hawkins, MD, MPH

Site-Principal Investigator: Patricia Agaba, BmBcH

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 characterize of the vaginal microbiota in all study participants. The vaginal microbiota composition and microenvironment, and the relationship between HPV infection and characteristics of vaginal microbiome in the evolution of CIN will be analyzed.

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Country: China

Partner Institution: Shanxi Medical University 

Principal Investigator: Lifang Hou, MD, PhD

Site-Principal Investigator: Jintao Wang, PhD

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 multi-drug-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, Mali study, and D43 training program, PIs: S. Diallo and R. Murphy) to develop a new diagnostic test that will differentiate M. tuberculosis complex (MTBC) from the treatable and the most common NTM, M. avium complex (MAC).

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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

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. 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. The epidemiology of latent PCa and the benefits of screening are unknown in Nigeria as prior studies did not examine the entire prostate. 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). 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. Given the genetic ancestral ties, this has implications for Nigerians. 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. We also identified new PCa risk variants in chromosome 8q24 in Nigerians which were replicated in Ghanaian and Ugandan men. 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. This is consistent with the fact that AAs are genetically about 80% WA and 20% European. 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.

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Country: Nigeria

Partner Institution: Jos University Teaching Hospital 

Principal Investigator: Adam Murphy, MD, MSCI

Site-Principal Investigator: Ayuba Madachi Dauda, BmBcH