Awards

Ayokunle Olanrewaju, and collaborators Ashleigh Theberge and Erwin Berthier, of the University of Washington in the U.S. will develop a platform for at-home self-collection of blood, serum separation, and sample stabilization at sufficient sample volumes for comprehensive HIV monitoring. An existing device for home blood collection will be expanded with the development of serum separation using a simple filtration system and connected to a standard blood collection tube with serum-stabilizing reagents. The device design will be optimized to ensure that over 1 mL of blood can be processed. The resulting design will then be tested for its effectiveness for RNA and protein analysis to monitor HIV viral load and biomarkers associated with HIV treatment and care. Performance of the device will be compared to standard blood processing, using blood from healthy volunteers spiked with either HIV RNA or C-reactive protein as a model biomarker. They envision a system that can readily integrate with standard laboratory or point-of-care diagnostic workflows to enable maximal deployability.

Lisa Rohan of the University of Pittsburgh in the U.S., with Thesla Palanee-Phillips of the Wits Health Consortium (Pty) Ltd in South Africa, will develop a vaginal film technology for the sustained release of the hormone levonorgestrel as a product that provides contraception and reduces heavy menstrual bleeding. Levonorgestrel is a progestin, a synthetic hormone that mimics the effects of progesterone. They will create and compare vaginal films with differences in mechanical properties, mucoadhesion, and drug release profiles to design a product that is low-cost, self-administered, and active for one month. They will also conduct a pilot trial of two prototype placebo films without levonorgestrel, evaluating them for safety, acceptability, and mucoadhesion in 20 women in South Africa, half with heavy menstrual bleeding.

Joyce Were of the Kenya Medical Research Institute in Kenya will develop a screening tool for assessing heavy menstrual bleeding that is adapted for use in Kenya by integrating two globally used questionnaires, adding material to incorporate the impact on women in the Kenyan context, and translating it into the locally spoken languages Swahili and Luo. Through consultations with experts, the tool will combine the Menstrual Bleeding Questionnaire (MBQ) with the Screening Assessment and Measurement of Atypical and Normal Menstrual Patterns Tool for Adolescents and Adults (SAMANTA), and it will incorporate new questions. The tool will be iteratively modified through small pilot tests. It will then be administered to adolescent girls and young women in Western Kenya as part of the Health and Demographic Surveillance System (HDSS) of the Kenya Medical Research Institute (KEMRI), with 70,000 participants surveyed with either the new tool or the MBQ or SAMANTA tools for comparison.

Jennifer Anyanti of the Society for Family Health with Clara Ejembi from Ahmadu Bello University, both in Nigeria, will evaluate patient experiences and treatment outcomes in women with heavy menstrual bleeding in Nigeria, with a focus on increasing the effectiveness, acceptability, and accessibility of hormonal contraceptives as treatment. Clinical data will be collected for a cohort of women receiving care for the condition in Kaduna state in Nigeria, together with qualitative data from interviews with patients, care providers, and supply chain managers. This information will be used to design and pilot targeted interventions to increase access to acceptable and effective treatment, such as community health education, supply chain improvements, and treatment programs. Such interventions can be iteratively improved with the original evaluation framework, generating a sustainable data management system to guide improvements in patient-centered care for heavy menstrual bleeding.

Anne Beatrice Kihara with Moses Madadi, both of the University of Nairobi in Kenya, will pilot a multipronged approach to support research and development for women’s health in Kenya. They will co-develop a policy and regulatory framework that integrates gender equity, working with government stakeholders, including the Ministry of Health and regulators, as well as civil society groups and women-led organizations. They will develop case studies of healthcare technologies for women’s health, focused on how accessible these technologies are for women in underserved communities; launch community-based campaigns to increase awareness and understanding of women’s health and healthcare solutions; and train healthcare professionals in applying an equity perspective in women’s health research and care. Community feedback will guide an iterative approach throughout these efforts.

Mathew Njoroge of the University of Cape Town in South Africa, with Roslyn Thelingwani of the African Institute of Biomedical Science and Technology in Zimbabwe, will analyze liver tissue from an African patient biobank to characterize the variability in drug metabolism in African populations. The analysis will combine genotyping, in vitro physiology studies, and pharmacokinetic modeling. Using the biobank samples, they will perform targeted sequencing of genes known to be associated with drug absorption, distribution, metabolism, and excretion, and then use the genotyped samples for in vitro analysis of drug clearance. This data will be combined with data modeling to predict the variability of drug pharmacokinetics in vivo to guide drug development and inform the design, monitoring, and interpretation of clinical trials.

Denali Dahl of Kalia Health, Inc. in the U.S. will evaluate Activin A and Inhibin A as urinary biomarkers for prediction and detection of preeclampsia early in pregnancy. This work builds on an ongoing biomarker validation study in Bloemfontein, South Africa. Through collaborations, clinical studies will be performed with blood and urine sampling in cohorts of pregnant women. Studies in Stellenbosch, South Africa will assess how levels of the two proteins vary in urine during pregnancy, and studies in Bloemfontein, South Africa will assess how early in pregnancy they can serve to predict preeclampsia risk. Activin A and Inhibin A levels in urine will be measured by MSD, and their diagnostic value will be compared to a standard assay for the biomarker protein ratio sFlt1/PIGF in blood and to clinical diagnosis by the treating physician.

Cliveland Ogallo of the Center for Public Health and Development (CPHD) with Anne-Beatrice Kihara of the University of Nairobi, both in Kenya, will assess the impact of heavy menstrual bleeding on the health and well-being of adolescent girls in an underserved community in Kenya. Girls in the Kibera urban informal settlement will be surveyed, along with guardians and health workers, to assess the prevalence of self-reported heavy menstrual bleeding; menstrual health literacy and associated cultural narratives; hygiene practices; access to healthcare products and services; and impacts including anemia, school absenteeism, and psychosocial well-being. Small-scale interventions will also be piloted, such as introducing menstrual kits with educational packets and dedicated physical spaces for menstrual hygiene.

James Beeson of the Burnet Institute with Stephen Scally of The Walter and Eliza Hall Institute, both in Australia, will develop candidate malaria mRNA vaccines designed to confer multiple types of immunity over multiple lifecycle stages of the malaria parasite. They will start with lead candidates that target Plasmodium merozoites, screening them with a human organoid model of the germinal center for their ability to activate B cell responses. Based on these tests, they will add antigens and test the resulting multi-antigen vaccines in animal models to create candidates that confer anti-merozoite, anti-sporozoite, and transmission-blocking immunity.

Brian Sullivan of Arcturus Therapeutics, with Sean Murphy of the University of Washington Foundation, both in the U.S., will pilot test a self-amplifying mRNA vaccine technology as a platform for developing malaria vaccines. They will use a mouse model of malaria, establishing infections in parallel with two different Plasmodium parasite species. They will test preventive treatments in this model, comparing self-amplifying mRNA vaccine technology to conventional mRNA and comparing intramuscular versus intravenous administration. They will assess the ability of each test vaccine to protect against liver-stage infection, determining the number of liver-stage parasites and how well the vaccine elicits potent, malaria-specific T-cell responses in the liver. The prolonged antigen expression characteristic of self-amplifying mRNA vaccines could be particularly valuable in inducing long-term protection against malaria.

Neha Lasure of Intignus Biotech Pvt. Ltd. in India will develop an affordable point-of-care diagnostic platform for prediction and detection of preeclampsia early in pregnancy. The diagnostic test is a lateral flow immunoassay that detects two key preeclampsia biomarker proteins in blood: sENG and PIGF. They will generate monoclonal antibodies against these proteins, manufacture test kits, and train frontline health care workers to administer and interpret the test. They will then perform a pilot study with 2,000 pregnant women in the Indian states of Pune and Mumbai, evaluating prediction accuracy compared to clinical outcomes and standard existing clinical tests.

Sarah Leeber of the University of Antwerp in Belgium, with Marie Josiane Kenfack of the Center for Research on Emerging and Reemerging Diseases (CREMER) in Cameroon, will add DNA sequencing analysis of the vaginal microbiota as a component for a set of clinical trials of menstrual hygiene products in Belgium, Switzerland, Cameroon, and Peru. The longitudinal trials compare use of different menstrual products, with participants using either the same product over time or different products in sequence, including pads, tampons, cups, and underwear. Surveys and group discussions will be used to gather data on user perceptions of the products and how acquiring knowledge of the microbiome may influence attitudes and practices. Shotgun metagenomic sequencing from self-collected samples will reveal changes in the vaginal microbiota associated with different products. Together, this data will provide a more comprehensive understanding of both the biological and behavioral dimensions of menstrual product use.

Almaz Negash of the African Diaspora Network in the U.S. will build an AI-augmented collaboration hub that matches senior African scientists with experienced researchers and innovators in the African diaspora. The hub will include AI-assisted profiling of skills and needs, focusing on areas including pharmacogenetics, pharmaceutical manufacturing for preclinical and clinical trials, infectious disease control, and data science. The hub will host monthly masterclasses and peer-learning sessions, and it will support co-designed research, co-supervision of students, joint grant applications, and technology transfers. It will be launched with an inaugural cohort of Africa-based scientists, including the Calestous Juma Fellows as an existing network of science leaders already embedded in African universities and research centers.

Margaret Ilomuanya of the University of Lagos in Nigeria will develop a multifunctional microneedle patch for delivery of agents that treat heavy menstrual bleeding while preventing disease from sexually-transmitted viral infections. The patch will be designed for use on the abdomen or thigh, and it will have a layered architecture to deliver multiple drugs: tranexamic acid and the progesterone-mimic levonorgestrel to reduce bleeding (with levonorgestrel also having contraceptive activity) and the antiviral drug tenofovir. Microneedle-delivered tranexamic acid and levonorgestrel will be tested, both for their safety and their ability to control bleeding, in assays including clotting in vitro, a rat model, and a rabbit model of menstruation. Women experiencing heavy menstrual bleeding will be engaged for group discussions to assess the acceptability, usability, and desirability of the microneedle patch compared to existing treatment options, such as oral tranexamic acid and hormonal intrauterine devices.

Sara Khalid of the University of Oxford in the United Kingdom will use large data sets from Kenya, Pakistan, and the United Kingdom to better understand the health impact and treatment challenges associated with heavy menstrual bleeding in low-resource settings. The project is a collaboration between Oxford University, Aga Khan University Kenya, and Aga Khan University Hospital Pakistan, with analysis of existing data sets in these three countries covering over twenty years of data for women diagnosed with heavy menstrual bleeding. For Kenya and Pakistan, analysis will encompass disease burden and epidemiology; patterns in treatment access, adherence, and effectiveness; and risk factors, with a risk prediction tool generated for heavy menstrual bleeding and its adverse outcomes. Equivalent analysis will be performed with data from the United Kingdom stratified by ethnic group to identify unique and shared features of the condition across settings.

Brandon DeKosky of the Massachusetts General Hospital, with Carole Long of the National Institute of Allergy and Infectious Diseases, both in the U.S., will develop a high-throughput, microfluidic screening platform to identify antibodies active against blood-stage malaria parasites. The platform is based on individual droplets containing a mix of Plasmodium parasite-infected and uninfected red blood cells together with mammalian cells secreting monoclonal antibodies. Each droplet serves as a parasite neutralization assay: antibodies that block parasite invasion of new red blood cells limit growth of the parasite population, and this is readily quantified using parasite-specific protein activity. With miniature droplets assayed in parallel, mammalian cells expressing a library of monoclonal antibodies can be rapidly screened for antimalarial activity.

Nadia Diamond-Smith of the University of California San Francisco in the U.S. will characterize the prevalence and impact of heavy menstrual bleeding as well as treatment preferences in a cohort of women in the state of Rajasthan in India. Building on an ongoing survey, new data will be acquired from 1,500 women in Rajasthan, including newly married women and their mothers-in-law. The prevalence of heavy menstrual bleeding will be determined, and the data will be modeled for its impact on women's physical and mental health. Twenty-five in-depth interviews will be performed, with the information used to design and launch a discrete choice experiment through a survey of 300 women from the cohort with heavy menstrual bleeding. This survey will uncover women's preferences across treatment options for the condition, including their willingness to pay for them, setting the stage for designing treatment programs based on the local context.

Ianessa Morantte of Prolific Machines Inc. in the U.S. with Arif Jetha of Radiant Biotherapeutics Inc. in Canada, are combining complementary platforms to enhance the production of broadly neutralizing antibodies (bnAbs) against HIV. Radiant has developed the Multabody platform™, which uses a self-multimerizing scaffold to multimerize antibody fragments. These fragments will be expressed using Prolific's proprietary Photomolecular Biomanufacturing Platform, which leverages light-controlled (optogenetic) cell lines that provide tunable gene expression control, facilitating expression of complex biotherapeutics. Stable, optogenetic host cell lines will be engineered by Prolific Machines to express multimers, each with a different combination of antibody fragments. The system will be assessed for its ability to increase Multabody yields by separating growth and production, and provide control over antibody fragment ratios with light, with the goal to pursue scale-up at a cost low enough to broadly increase access.

Annie McDougall of the Burnet Institute in Australia will develop a digital tool for point-of-care prediction of preeclampsia risk early in pregnancy, using data from clinical trials in Sub-Saharan Africa. A predictive model will be developed and validated using data from an ongoing set of clinical treatment studies in Ghana, Kenya, and South Africa: the PEARLS trial (Preventing Preeclampsia: Evaluating Aspirin Low-Dose Regimens Following Risk Screening). This model will be used to develop a tool for automated preeclampsia risk stratification to support clinical decision making by antenatal care workers. It will be designed for integration into existing digital health platforms, including real-time patient data entry. The tool will be evaluated for usability, feasibility, and acceptability through interviews and workshops with patients and care workers in two of the PEARLS trial countries.

Javan Esfandiari of Chembio Diagnostics, Inc. in the U.S. will develop an affordable point-of-care diagnostic platform for prediction and detection of preeclampsia early in pregnancy. The diagnostic test is a semi-quantitative lateral flow immunoassay to monitor the level of the key preeclampsia biomarker protein sFlt1 in whole blood from a finger prick. The test will discriminate between two levels of the biomarker, identifying patients at either low, medium, or high risk of developing preeclampsia, and it will be integrated into a low-cost, portable reader device. Through local collaboration, the prototype device will be tested in France, Nigeria, and Benin. In each country, 100 women with identified risk of preeclampsia will participate. For comparison with the diagnostic test results and predicted preeclampsia risk, patient clinical outcomes will be recorded, and serum samples will be tested at a central laboratory, using existing tests to measure sFlt1 and the sFlt1/PIGF biomarker ratio.