All Awards

Everett Tate of the University of Chicago in the U.S., with collaborators in the United Arab Emirates, Ghana, Kenya, South Africa, and India, will establish a multi-site consortium for research on heavy menstrual bleeding. Consortium sites, including hospitals, clinics, and universities, will standardize processes for collecting patient samples and data, and they will establish a database integrating immune and cytokine profiling, genetic analysis, and ultrasound imaging, including AI-based data modeling. They will also perform epidemiological analyses, incorporating data gathered from patients visiting mobile health vans, to better understand the geospatial distribution of heavy menstrual bleeding prevalence and risk. The consortium approach will provide a framework to improve the accuracy, efficiency, and accessibility of early diagnosis of the condition in low-resource settings.

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.

Hatice Ceylan Koydemir with Sandun Fernando at Texas A&M University in the U.S., working with Levent Beker and Ebru Celik of Koç University in Turkey, will develop an affordable point-of-care diagnostic platform for prediction and detection of preeclampsia early in pregnancy. By employing sensor miniaturization and integrating with low-cost electronic devices, they aim to provide a battery-less, easy-to-use, portable platform for automated data analysis at the point of care, particularly suitable for use in low- and middle-income countries (LMICs). They will evaluate the prototype device using human serum samples spiked with preeclampsia biomarker proteins, as well as serum samples collected from over 100 participants at Koç University Hospital in Turkey and an LMIC setting, comparing the device's results to hospital clinical reports.

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.