Breakthroughs Blog: Access

Seasonal malaria chemoprevention (SMC) is one of the best ways to protect children from malaria. No one knows this better than community health volunteers who go door to door helping families protect their children from malaria by administering medicines.SMC reached approximately 56 million children in 2025 in sub-Saharan Africa. Its success depends on community participation, from local volunteers to parents administering treatment at home.Community members have long been essential to the successful delivery of interventions like SMC. Researchers are increasingly recognizing the value of bringing their perspectives into research much earlier.Bringing community perspectives into researchCommunities are not just participants in research; they are experts of their lived experiences. Their insights help shape not only the delivery of interventions, but also their design and development to ensure that interventions fit the realities of the communities they are intended to serve. Civil society organizations like Impact Santé Afrique, product development partnerships, and research institutions are working to make community engagement an integral part of health research and innovation. Meaningful engagement means more than being invited to comment on decisions; communities must have opportunities to raise concerns, challenge assumptions, and see how their input has influenced research. This may include engaging communities before protocols are finalized, ensuring equitable representation in decision-making structures and, crucially, showing them what impact their input has had.This ethos is reflected in international research guidance. The Declaration of Helsinki, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice guidelines, and World Health Organization guidance on clinical trials increasingly recognize the importance of meaningful engagement with patients and communities. Putting community engagement into practiceThis approach has been applied in the ongoing Safety of Antimalarials in the FIRst TrimEster (SAFIRE) consortium’s clinical trials. This project is conducting clinical research in Burkina Faso, Mali, and Kenya to evaluate the efficacy and tolerability of several first-line antimalarials to treat women in their first trimester of pregnancy.At the start of SAFIRE, Medicines for Malaria Venture and other consortium partners conducted formative research, exploring community perspectives and cultural sensitivities that could influence participation in the study. As a result, the SAFIRE team refined communication materials to be more accessible across different literacy levels as well as culturally responsive to each country context. These insights also directly influenced trial design, informing participant identification methods, recruitment, informed consent, voluntary participation, and retention strategies. Building on the community advisory board model long used in HIV research, the Drugs for Neglected Diseases initiative has established regional Community Advisory Committees in Africa, Asia, and Latin America. These committees bring together patient advocates and people with different lived experiences of disease. Their role is not simply to react to research once decisions have been made, but to bring community perspectives into the decisions and materials that shape how studies are designed and experienced. Recent consultations show what this can mean in practice: for a Phase 3 dengue trial, community members and people with lived experience reviewed the informed consent and assent materials and made recommendations to improve the process by shortening consent forms, reducing repetition and technical language, and making the research process and goals clearer to participants, alongside what they should expect in terms of care, safety, and rights. Community engagement becomes meaningful when listening leads to action and communities can see how their input has shaped decisions and contributed to how interventions are developed and delivered. Engaging communities before decisions are made Community participation can begin even earlier, before decisions are made about developing, testing, or introducing a new intervention. Between 2024 and 2026, Mali’s University Clinical Research Centre conducted sociological research to assess communities’ understanding of genetically modified mosquitoes (GMMs) as a potential malaria control strategy. Although Mali is not yet using GMMs, this type of research helps generate evidence that can inform future scientific and policy decisions. Researchers engaged a broad range of stakeholders—including health workers, people living in both urban and rural communities, religious leaders and youth—in focus group discussions to gather qualitative data. Study participants were viewed as contributors rather than research subjects, with researchers soliciting their experiences, recommendations, and views on challenges and solutions that could arise in deploying this intervention.The findings showed that perceptions of GMMs varied according to factors such as gender, education levels, and trust levels in scientific and health institutions. At the same time, common ground also emerged, particularly around the need for transparent information, credible scientific data, trustworthy institutions, community consultation and meaningful participation in decision-making.Scientific innovation alone is not enoughScientific efficacy alone is not sufficient to ensure the acceptance of new interventions. They must also be perceived as socially and culturally legitimate and implemented through governance mechanisms that consider communities’ concerns, expectations, and values. Early engagement is also critical for building trust and supporting sustained, meaningful interactions with communities throughout scientific and clinical research.When advancing innovations to improve global health outcomes, product developers must treat communities as indispensable partners whose perspectives can improve the relevance, acceptability, and impact of new public health interventions. Communities have long played a role in delivering health interventions. They should also have a role in shaping them.

A study from the University of California, San Francisco found that a new long-acting HIV combination treatment could provide an alternative, more accessible option for some people with HIV. Long-acting treatment options can provide a simpler, more convenient alternative to daily pills for people living with HIV, but the only approved long-acting combination includes rilpivirine, which is not available in low- and middle-income countries, and the virus has been known to develop resistance to it and similar drugs. The new combination under study replaces rilpivirine with lenacapavir, which uses a different mechanism to target the virus. In the study, all participants achieved and maintained control of the virus. Additional clinical trials are planned to evaluate the approach more comprehensively, but, in the meantime, these findings could help guide care.  A team of researchers at the Massachusetts Institute of Technology has found a way to keep mRNA vaccines stable at higher temperatures, which could drastically lower costs and improve access to the technology in low-resource settings around the world. mRNA vaccines must be kept at extremely cold temperatures during transport and storage, requiring high costs and continuous monitoring. The researchers adjusted the formulation of the tiny particles that carry the mRNA, making them more resistant to heat. The vaccines the team produced can be stored at room temperature for up to a year or at nearly 100 degrees Fahrenheit for two months. Even after storage, the shots elicited equivalent immune responses in mice to the original formulations.The Medical Research Council/Uganda Virus Research Institute and the London School of Hygiene and Tropical Medicine have launched a Phase 1 clinical trial in Uganda evaluating the safety and immune response of a vaccine candidate for Bundibugyo, the severe strain of Ebolavirus behind the ongoing outbreak in the Democratic Republic of the Congo for which there are currently no licensed vaccines. Conducted in partnership with the Oxford Vaccine Group and Pandemic Science Institute at the University of Oxford, the trial builds on an ongoing Phase 1 trial of the same candidate in the United Kingdom. Both trials are funded by the Coalition for Epidemic Preparedness Innovations (CEPI). The candidate, ChAdOx BDBV, was developed by scientists at the University of Oxford and uses the same platform as the Oxford/AstraZeneca COVID-19 vaccine. 

Recently published results from a large multi-country study found that pooled tuberculosis (TB) testing could greatly reduce costs and boost access to diagnosis. Access to the gold standard of rapid molecular testing is limited—only just over half of people diagnosed with TB in 2024 were first tested using the technology. Instead, they were diagnosed using older technology, which can take weeks to produce results, during which the infection could progress or be transmitted to others. Millions of additional individuals with TB go completely undiagnosed. A major contributing challenge is that rapid molecular testing requires an expensive diagnostic cartridge for each sample. Pooled testing involves testing samples from multiple individuals with one cartridge. Patients are only retested individually if the result is positive. Unlike new diagnostic technologies, like AI-enabled portable X-ray machines, that are promising but would require additional funding to implement, pooled testing could be scaled up rapidly without new funding because it utilizes technologies that many labs already have.Medicines for Malaria Venture (MMV) is advancing the novel, first-in-class antimalarial compound, cabamiquine, into the next stage of clinical development, with the hope that the compound could be part of a single-dose, long-acting treatment for the prevention and treatment of malaria, which could greatly simplify care compared to current options. Cabamiquine was discovered by researchers at the University of Dundee, with financial and scientific support from MMV, and then advanced by Merck to proof of concept. Recently published results from two Phase 2a trials showed that a regimen of cabamiquine and pyronaridine was able to clear uncomplicated Plasmodium falciparum malaria in more than 90 percent of participants and demonstrated a strong safety profile. MMV will now lead Phase 2b clinical development of the compound. The Biomedical Advanced Research and Development Partnership (BARDA) recently announced that it has awarded Scynexis a $214 million contract for the development of an antifungal to treat and prevent invasive fungal infections, the less common but more serious form of fungal infection that penetrates deep into the tissues of the body. Fungal infections are a growing global challenge, but there is a significant gap in the pipeline of new tools to address them. Last year, the company reported positive findings from a Phase 1 trial of an oral dose of the candidate and is currently conducting a Phase 1 trial of an intravenous formulation. The award includes initial funding to advance the company’s antifungal candidate into Phase 2 trial, with an option for additional, longer-term funding. 

Recently published results from a Phase 2b trial testing a new regimen for people with chronic Trypanosoma cruzi infection could offer a safer, more practical treatment option for the infection, which affects more than seven million people globally, mainly in Latin America, and can develop into Chagas disease. Compared to the current standard regimen that involves twice-a-day treatment for 60 days and is frequently accompanied by uncomfortable side effects, leading to treatment failure, the new regimen involves a 30-day course taken once daily. Trial participants treated with the shorter regimen had significantly reduced side effects, found it easier to follow, and saw lower treatment interruption. If it continues to demonstrate success in large Phase 3 trials, the regimen could transform treatment for patients globally, as T. cruzi infection becomes a growing challenge in the United States, Europe, and Japan.The first participants have been vaccinated in a trial in the Democratic Republic of the Congo (DRC), where the country’s ongoing outbreak of the Bundibugyo strain of Ebola has now become the largest Ebola outbreak in the country’s history and the second largest in history. Health workers in Bunia, a DRC city at the center of the outbreak, were the first to be vaccinated in the real-world efficacy trial evaluating whether the Ervebo vaccine, which is designed to target the more common Zaire strain, offers some cross-protection against Bundibugyo. There are no approved vaccines for Bundibugyo Ebola, and there were no candidates in late-stage development before the start of the outbreak of the rarer strain of the virus, which has only caused three outbreaks since it was first discovered around 20 years ago. Since the outbreak began, global partners have fast-tracked the development of earlier-stage candidates, but researchers hope the Ervebo vaccine could provide some protection before those candidates are ready for evaluation in DRC. As artificial intelligence (AI) continues to rapidly transform many aspects of technology and science, including health research, a new report from the World Health Organization (WHO) speaks to how stakeholders can help ensure AI-enabled health research is conducted responsibly and benefits everyone. According to the report, while AI has the potential to accelerate health innovation and improve health outcomes, it also presents risks related to equity, privacy, safety, transparency, and more. WHO suggests that researchers, ethics committees, regulators, funders, and policymakers can act to strengthen ethical oversight of AI throughout the health research continuum. WHO also notes that most AI development remains concentrated in high-income settings and contends that strengthening leadership, capacity, and participation in AI in low- and middle-income countries will be important to ensuring the technology does not exacerbate existing inequities in health and health research.