Program areas at PATH
The programs & innovation division brings deep technical expertise and a robust, collaborative, and interdisciplinary approach to support Path country programs and partners in advancing health equity. We focus on generating analytical insights, translating them into advocacy and action, advancing inclusive and sustainable innovation, and strengthening workforce skills and resources that support integrated and resilient health systems. Our work covers digital transformation and data use, primary health care, diagnostics, product development, market shaping, epidemic preparedness and response, malaria and neglected tropical diseases, and more. (continued on schedule o)center of digital and data excellencepath uses digital technologies and data-driven strategies to advance health equity. In 2023, Path's center of digital and data excellence catalyzed country-led digital health transformation in numerous ways.work concluded on the data use partnership (dup) and the digital health ecosystem (dhe) projects. Dup, a project funded by the bill & melinda gates foundation, was transitioned to the government of tanzania to continue enhancing their health information systems and use of data. The project culminated with establishing the center for digital health, which will serve as a central coordination point focused on governance, technology, workforce capacity, research, and change management, ensuring that tanzania remains at the forefront of digital health innovation.the dhe project, funded by the bayer foundation, wrapped up work to support sustainability and expansion of digital tools for health by helping local african entrepreneurs more easily access financing, technical resources, and opportunities for scale.digital square, a path-led initiative backed by a united states agency for international development (usaid) investment of up to $170 million through 2026, continued to bring donors and partners together to improve how the global community designs, uses, and pays for digital health tools and approaches with an emphasis on country-driven priorities. Highlights from 2023 included welcoming a new executive director, dr. bilal mateen; producing a digital version of the digital square global goods guidebook; launching the enterprise architecture for digital transformation in burkina faso, the democratic republic of congo (drc), and senegal; concluding the pilot digital health applied leadership program; and continuing to partner with other implementers and organizations to support open-source digital tools.in 2023, the digital results improved vaccine equity and demand (drive demand) project, funded by the rockefeller foundation, continued to understand, track, and influence demand for immunizations in five countries.the digital innovation in pandemic control (dipc) project, funded by deutsche gesellschaft fur internationale zusammenarbeit (giz), continued partnering with ministries in ghana, malawi, and tanzania to select and adapt robust digital tools to strengthen immunization systems.path, with us centers for disease control and prevention (cdc) funding, is leading overall health information system (his) support activities as part of the us president's emergency plan for aids relief (pepfar) technical assistance platform (tap), which partners with countries to build lasting digital health capacity. In 2023, the team began implementing the fourth year of the project, with a focus on national health data policies and governance, health information system standards, and health information system workforce strengthening. Through tap, Path worked to strengthen health systems for hiv and/or covid-19 in botswana, cte d'ivoire, drc, ethiopia, haiti, kenya, namibia, nigeria, rwanda, uganda, vietnam, and zambia.path continued to participate in high-level global coalitions, including transform health; the health working group for recommendations for g20 leaders; the world health organization's (who) global initiative for digital health; the digital connected care coalition; the digital public goods alliance; and the digital public goods charter campaign.diagnosticspath's diagnostics program aims to advance and increase access to high-quality and appropriate diagnostics that improve the health outcomes of people and communities in low-resource settings.in 2023 Path supported the advancement of affordable and reliable diagnostics, proteins, antibodies, and tools by aiding the development, commercialization, and procurement of new technologies; conducted performance evaluations and clinical studies to inform patient care; facilitated a g6pd (glucose-6-phosphate dehydrogenase) operational research community of practice; and published nine peer-reviewed articles. We continued to contribute to the availability of cost-effective and dependable diagnostic solutions in low-resource settings, ensuring that communities in need have access to tools for an accurate and timely diagnosis.abbott diagnostics is developing a next-generation tb lam assay. Path is supporting abbott's research and development efforts by qualifying urine samples using our in-house reference assay for tb lam measurement. Once the new assay is ready, the university of Washington will conduct clinical studies of it. Path will receive the urine samples tested by the abbott assay and qualify the test result for tb lam using the in-house reference assay.the equals project successfully defined the content of internal quality controls required to qualify test results derived from wastewater surveillance. This was achieved through consultation with the technical advisory group. However, consensus on the design of external quality controls has not been reached, so discussions are ongoing with stakeholders to identify their composition.with poliovirus surveillance, we have successfully scaled up testing in pakistan to 40 sites across the country. Afghanistan is still on hold as we wait for guidance from the gates foundation. Support from the who regional office for the eastern mediterranean (emro) in yemen is ongoing, and they have expanded collection to four sites from the original three.we have completed research and development (r&d) of the serotype-specific urinary antigen detection assay for pneumococcal surveillance. Quansys has completed their phase ii effort, and in 2024, we will proceed with a product lock and qualify the assay for production. The cdc has agreed to support a clinical evaluation of a clinical panel that they have.for point-of-care (poc) molecular diagnostics, we selected 14 different manufacturers of poc covid-19 molecular assays and assessed them using a test panel to determine the best in class, a second series of performance assessment at Path. We also evaluated their usability, providing feedback to the developers on the design features and instructions for use. Through this process, we successfully identified several tests that were best in class.the remaining funds for the demonstration sample repository and diagnostic device evaluator project were rolled into the apollo project to provide further resources for testing.to enhance the security of local diagnostic supply chains in low- and middle-income countries (lmics), Path conducted a comprehensive landscape analysis to determine key market failures and identify market-shaping interventions needed to expand access to high-quality diagnostics. This included developing an interactive dashboard that consolidated publicly available data on diagnostic companies with a manufacturing presence in africa, latin america, and southeast asia. The dashboard increased the visibility and awareness of these companies within each region while providing an overview of their product portfolios and quality systems.path continued its support of diagnostic tools for malaria case detection and case management. Specifically, Path completed clinical studies to advance next-generation rapid diagnostic tests for malaria and supported the characterization of specimens from these studies in ethiopia and senegal. Path also evaluated rapid diagnostic tests and reagents, such as antibodies, from a series of manufacturers in its laboratory. To increase access to g6pd testing, which is essential for treating plasmodium (p.) vivax malaria patients, Path continued with the support of one manufacturer in its responses to who prequalification, and advanced the development efforts of a second manufacturer toward clinical studies. The performance of the second product was evaluated in a preclinical study, in anticipation of regulatory studies for 2024. Path has also continued to plan implementation studies in ethiopia and vietnam for both the g6pd test and new treatments for p. vivax, which we anticipate will begin in 2024.
Asia, middle east, and europe region: Path's leadership in the asia, middle east, and europe (amee) region leverages our global expertise across multiple health disciplines to champion equity in access to care, introduce new technologies and approaches, and partner across sectors to provide human-centered care and support. Path coordinates our work in this region from offices in nine countries, including offices in china, india, ukraine, vietnam, and switzerland that serve as regional hubs for technical and scientific innovation and program delivery. (continued on schedule o)highlights include:in 2023, Path intensified its efforts in local and regional collaborations, particularly in bangladesh, indonesia, laos, and nepal, and explored new collaborations in the middle east. This expansion was fueled by an increased demand for our services, necessitating substantial growth in our workforce within the region.path prepared for and responded to emerging health threats in the region by providing technical support, enhancing laboratory capacity, and scaling up innovations. Path's proactive response to emerging health threats included mental health support in myanmar, climate-health initiatives in india, tackling antimicrobial resistance in vietnam, and enhancing laboratory and tb treatment capacities in ukraine.thanks to our continuous work in improving lives through science and technology, we have achieved significant advancements in various areas, such as health care waste management in myanmar, rice fortification in india, noncommunicable diseases prevention among vietnamese adolescents, and revolutionizing hepatitis self-testing. Our efforts in vaccine development and manufacturing, particularly in china, have enhanced global access to vaccines against diseases like influenza, hpv, and japanese encephalitis.throughout the year, our amee programs focused on enhancing primary health system services and resilience using a community-based approach that brings awareness, availability, and accessibility of health services to the people who need them. Some of the initiatives included launching national hpv vaccination and strengthening immunization in bangladesh, digitalizing health records in india, strengthening newborn nutrition in nepal, and bolstering the primary health care system in ukraine.path elevated its presence at major international forums, including the g20 meetings in india, focusing on prioritizing digital health investments and fostering a global vaccine research collaboration. Additionally, our collaboration with the commonwealth secretariat to launch the accelerator for resilience in climate and health marks a significant stride in sourcing, deploying, and scaling innovations for better climate-health outcomes across the globe.in 2023, we not only continued our collaboration with longstanding donors but also established new strategic alliances with major institutions like the asian infrastructure investment bank, king abdullah university of science and technology, asian development bank, deutsche gesellschaft fr internationale zusammenarbeit (giz), kfw bankengruppe, children's investment fund foundation (ciff), and novartis to tackle key challenges in climate change, digital innovation, and healthy living to bring health and well-being to all.
Essential medicines:path's essential medicines division develops and delivers lifesaving vaccines and drugs for communities around the globe--especially women and children. (continued on schedule o)center for vaccine innovation and accesspath's center for vaccine innovation and access aligns expertise across every stage of vaccine research, development, and introduction to make vaccines available to more communities, particularly in low- and middle-income countries (lmics). Our portfolio includes more than two dozen vaccine products in development or already in use, with an emphasis on the leading infectious causes of child death and disease worldwide.in 2023, Path continued to support covid-19 prevention and emergency response preparedness by coordinating grants to research groups conducting trials of covid-19 vaccines at fractional doses in low-resource settings. We supported the mrna vaccine technology hub in south africa and provided coordination and technical assistance for a consortium developing an egg-based covid-19 vaccine for production in brazil, thailand, vietnam, and other lmics. Path, in collaboration with the world health organization (who), continued to curate the covid-19 maternal immunization resource librarya one-stop online hub for public health information about covid-19 vaccines and pregnancy.in ongoing efforts to facilitate local vaccine production, Path supported lmic vaccine manufacturers to ready locally made vaccines for the global market, thereby increasing available interventions and potentially making vaccines more accessible for lmics. We provided technical assistance to several manufacturers preparing for who prequalification submission or inspection, supported manufacturers in clinical trial design and regulatory filings, mapped the current vaccine manufacturing capacity in africa, and supported clinical assay development and technology transfers, among other activities.path continued to provide technical support to polio vaccine manufacturers and advance research on new inactivated polio vaccine and oral polio vaccine candidates. In 2023, novel type-2 oral polio vaccine received who prequalification, and a novel type-1 oral polio vaccine candidate advanced to phase 2 study.throughout the year, Path and our partners expanded coverage of japanese encephalitis (je) vaccination and finalized and disseminated evidence to support je vaccine decision-making. Path concluded studies on the cost of illness for je and its long-term consequences in bangladesh, laos, and vietnam. Path held a bi-regional meeting in vientiane, laos, in october 2023 to bring stakeholders together to discuss lessons learned, identify opportunities for further je vaccine introduction and scale-up, and continue the momentum for je control. Path's je projects concluded in december 2023.also in 2023, menfive, the polyvalent meningococcal meningitis conjugate vaccine (mmcv) that Path supported in development, clinical studies, and regulatory submission, received who prequalification. Prequalification confirms the vaccine meets strict international quality standards and can be made available on the global market. Developed by serum institute of india pvt. Ltd., menfive builds on the success of menafrivac, a groundbreaking vaccine against serogroup-a meningococcal meningitis that was developed through an earlier Path partnership. The polyvalent vaccine targets serogroups a, c, w, x, and y. As the first vaccine to target serogroup x, the vaccine has the potential to eliminate meningococcal meningitis epidemics from africa's "meningitis belt" region. We also continued to contribute technical and strategic expertise to the global defeating meningitis by 2030 initiative. And, we served as a coordinator between who, gavi (the vaccine alliance), and global partners to identify pathways to accelerate mmcv introduction once the vaccine is made available, which led to a recommendation by who's strategic advisory group of experts on immunization that menfive be introduced via vaccination campaigns and routine administration in the meningitis belt.path also accelerated the introduction of malaria immunization in 2023. We continued to work with who; the ministries of health in ghana, kenya, and malawi; and other partners to introduce and share information about the malaria vaccine. We continue to advance research into dose schedule, uptake, and efficient delivery of both available malaria vaccinations that are pre-qualified and recommended by the who: rts,s and r21. In august 2023, we announced the results from a landmark study that confirmed the benefits of combining the vaccine with seasonal malaria chemoprevention to avert malaria in highly seasonal settings. In addition, we are sponsoring a first-in-human phase 1/2 trial that started in 2023 and is evaluating the safety and immunogenicity of the malaria vaccine candidate rh4.2-virus-like particle in matrix-m adjuvant. The defeat diarrheal disease initiative continued its role as a digital hub for information on preventing and treating childhood diarrheal disease, which is the second-leading cause of death among children in lmics. A major focus in 2023 was the opportunity for rotavirus vaccine impact in southeast asia and the role of climate change in increasing the incidence of diarrheal diseases, especially cholera. To reduce the burden of rotavirus, a major cause of severe diarrhea, Path completed a phase 3 efficacy study of an injectable nonreplicating rotavirus vaccine candidate at three clinical sites in africa. Path also completed a phase 2 study with this candidate in south africa to examine immune responses to different combinations of oral and injected rotavirus vaccines. Path began an observational, follow-on study to gather more information on rotavirus disease in the second year of life in ghana and malawi. In addition, in december 2023, Path completed a case-control study in india that evaluated the effectiveness of serum institute of india pvt. Ltd.'s licensed rotavirus vaccine, rotasiil. Path continued to support research related to vaccine candidates that may provide protection against shigella, one of the leading bacterial causes of diarrheal illness, for which there is currently no licensed vaccine. In 2023, we continued preclinical research on the novel, orally administered, inactivated whole-cell shigella truncated mutant vaccine candidate. We also concluded a clinical trial to test two experimental challenge strains of shigella. The results of this trial will help guide future development of shigella vaccines.path continued to advance preclinical development of a vaccine against group b streptococcus, a leading cause of bacterial sepsis and meningitis in young infants worldwide, and against pneumococcal disease, a top cause of deadly childhood pneumonia. We supported inventprise as it works to develop multivalent conjugate vaccines for both diseases that will be affordable for lmics. We also initiated work on a project to evaluate two different measles and rubella microarray patches. Clinical study preparations were underway throughout 2023. As part of the typhoid vaccine acceleration consortium, Path worked to advance typhoid conjugate vaccine (tcv) introduction in gavi-eligible countries. We provided support to the government of malawi to introduce tcv in may 2023 and make the transition to include tcv in routine immunization. We also continued to support the government of kenya to plan for tcv introduction. Additionally, Path worked with national decision-makers to advance applications for tcv introduction. Burkina faso completed and submitted an application for tcv introduction in 2023. In other countries, we initiated and/or continued discussions to support decision-making. We continued to share new data and serve as a hub for information on typhoid, raising awareness about the disease and its prevention through an integrated approach that includes vaccines.to prevent cervical cancer, Path continued to coordinate a consortium of nine independent research institutions to collate, analyze, and disseminate evidence on single-dose human papillomavirus (hpv) vaccination to who and other stakeholders. We initiated and coordinated a group of communicators engaging on hpv vaccination with regular meetings and shared calendar resources. In addition, we completed and disseminated findings of an hpv cost-of-delivery study in six countries. Also, we continued to partner with several lmics on the planning, implementation, and ongoing monitoring of national hpv vaccination programs. Finally, we continued to support a phase 3 clinical study of cecolin, a bivalent hpv vaccine that received who prequalification in 2021, to generate evidence on extended and alternative dosing schedules.
Africa regionpath's work in africa intersects virtually every Path global program, from advocacy and public policy to sexual and reproductive health. We have country offices in seven nations spanning central, eastern, southern, and western africa (drc, ethiopia, kenya, senegal, tanzania, uganda, and zambia) with project offices in five more. Highlights from our offices include:democratic republic of the congo(1) usaid-funded momentumroutine immunization transformation and equity (m-rite) project: the m-rite/path project significantly advanced covid-19 immunization efforts by training health zone management teams on the dhis2 aggregate form across eight zones, achieving a 17% increase in coverage. Furthermore, the m-rite/path project supported integration of vaccine services into 72 private health structures in ten zones in haut-katanga and kasai oriental, reducing geographical barriers and vaccinating 33,481 children, including 4,348 with no prior doses. Additionally, the official launch of community polio surveillance activities in these provinces involved over 400 participants and extensive media coverage. A cascade training course was conducted for 318 health agents, community relays, and health zone staff on community-based surveillance. (2) drc zero-dose children technical assistancetechnical support was provided for the national workshop to contextualize interventions in the zero-dose and under-vaccinated children reduction plan 20232025. This included revising tools for the catch-up plan for children aged 12 to 59 months missed during the covid-19 pandemic (20192022) and initial planning of the zero-dose and under-vaccinated reduction plan. (3) national polio surveillancepath supported the expanded program on immunization (epi)-drc in developing the "strategic plan to stop the circulation of poliovirus derived from the type 1 and type 2 vaccine strain in drc" for provinces including maniema, tanganyika, and haut-lomami. Eight vaccination campaigns were implemented to combat variant poliovirus types 1 and 2, reducing lab-detected cases from 539 in 2022 to 281 in 2023. Additional efforts included drafting plans to interrupt the circulation of cvdpv1, cvdpv2, and vdpv3 in the drc for early 2024 and initiating the river strategy project in haut-lomami, funded by the gates foundation. Training was provided for 10 health zone managers, 68 head nurses, and 170 community relays on community-based surveillance and vaccination referrals in haut-katanga and kasai oriental. (4) digital square projectpath supported the drc ministry of public health, hygiene, and prevention in its digital transformation through the digital square initiative. In 2023, Path facilitated the launch of the enterprise architecture approach for digital health, involving key stakeholders and developing a governance framework. Anicns, drc's digital health agency, participated in the global digital health forum, sharing the drc's experiences with international experts. (5) cdc tap-hiv data systems for uhcthe cdc tap project established a technical working group focused on hiv response and digital health, chaired by anicns and co-chaired by pnls (drc's national hiv/aids and sexually transmitted infection control program). An assessment of the health information system was conducted, leading to the development and dissemination of a roadmap addressing identified weaknesses. This roadmap facilitated the launch of multiple projects aimed at system improvements. (6) the malaria control and elimination partnership in africa (macepa) projectthe drc macepa 4 project supported the drafting of a concept note for the global fund's grant cycle 7, involving key partners in malaria control. The project developed a malaria research, development, and quality assurance guide, conducted data quality assessments, and contributed to strategic planning documents such as the national program to combat malaria (pnlp) strategic plan 20242028 and the annual operational plan for 2023 and 2024. Efforts also included updating community health policies and supporting the development of the "guide de mise en oeuvre des sites de soins communautaires," the imci strategic plan 20242030, the annual operational plan 2024 of the pnchol-md, and the roadmap for strengthening community health of the community health sub-commission. (7) perennial malaria chemoprevention--givewellthe pmc-givewell project established a framework for collaboration, launching the perennial malaria chemoprevention (pmc) model in four health zones in november 2023. Training was provided for 687 stakeholders, including 11 provincial managers, 82 members of management of health zone teams, 24 field agents, 137 nurses, 359 providers, 74 prsicodesa, 370 community relays, and 54 recosites. By december 2023, 2,309 doses of sulfadoxine-pyrimethamine (sp) were administered to children under two. (8) source projectthe source project in 2023 included a biomedical equipment survey across 26 provinces, a qualitative survey on oxygen availability, and development of an advocacy plan for pneumonia treatment focused on oxygen and amoxicillin. A work plan for civil society organizations aimed at increasing the oxygen budget was also developed. (9) accelerating measurable progress and leveraging investments for pph impact (ampli-pphi)in 2023, the ampli-pphi project conducted a supply chain assessment and a pricing and availability survey for postpartum hemorrhage (pph) medicines, like oxytocin, tranexamic acid, and misporostol. Technical support was provided for quantifying pph commodities and developing scale-up and business case development plans for heat-stable carbetocine and tranexamic acid. (10) advocacy and public policyin support of the immunization program, the third national forum on vaccination and polio eradication, led by the president of the drc on june 2728, 2023, highlighted the country's high-level commitment to immunization. This event marked a significant partnership effort in the health sector. Additionally, two working sessions with the national repacav focused on the immunization performance of the epi in kisantu and kinshasa in april 2023. Workshops were held in kinshasa, tanganyika, and haut-lomami to raise awareness of provincial immunization commitments.political approval of pnc 2023-2027 was achieved with the involvement of gtfcc/csp, unicef, who, and other partners, with Path playing a key role in organizing the workshop by the pnc steering committee (copil). Following this, Path collaborated with gtfcc/csp, unicef, and who to organize a resource mobilization roundtable with private donors.for the polio response program, regular media briefings in kinshasa and the provinces resulted in 17 national media outlets publishing 27 articles and interviews about routine vaccination and campaigns, highlighting the efforts of the epi and its partners. Online communication efforts also strengthened, reaching 4,000 followers on twittera 30.7% increase from 2022with daily posts on routine vaccination and polio on twitter, facebook, instagram, and linkedin.human african trypanosomiasis (hat) technical assistance to csos:technical support was provided to civil society organizations for the 4th national day against sleeping sickness, with participation from local and international partners. Training was conducted for cnrsc staff on the gates foundation's lobbying policy, and political authorities were engaged in the hat elimination agenda in the drc.