STOP2030

The challenge

Soil-transmitted helminths are a group of parasitic worms that infect an estimated 1.5 billion people globally, with sub-Saharan Africa accounting for a large proportion of the disease burden. Key infections include: 

• Ascaris lumbricoides, a roundworm,
• Trichuris trichiura, whipworm,
• Necator americanus and Ancylostoma duodenale, both hookworms. 

WHO’s 2021-2030 Roadmap for NTDs aims for their elimination as a public health problem, mostly through a strategy of mass drug administration with either albendazole or mebendazole, targeting children and women of reproductive age. However, these drugs are only partially effective against T. trichiura. In addition, they do not effectively treat another common parasite, Strongyloides stercoralis (threadworm), which is often found in co-infections with other soil-transmitted helminths. Using albendazole or mebendazole on their own also creates selection pressures favouring the emergence of drug resistance. 

The STOP Consortium has been working for many years on an enhanced treatment for soil-transmitted helminths: a fixed-dose combination pill that includes both albendazole and ivermectin, a second highly effective anti-parasite drug. The EDCTP-funded STOP project’s ALIVE phase 2-3 trial in Ethiopia, Kenya and Mozambique has generated highly positive data on the efficacy and safety of this new combination treatment. 

The project

Building on these successes, the STOP2030 project is carrying out a range of activities to support the licensing and introduction of the new fixed-dose combination of albendazole and ivermectin in endemic countries. 

Core to the project is a pragmatic effectiveness trial that will provide evidence on the use of the fixed-dose combination in mass drug administration settings. Schools in Ghana and Kenya will be randomised to receive either standard albendazole-based mass drug administration or the fixed-dose combination. The study will track the prevalence of parasite infections at various time points after drug administration. Special safety monitoring systems will be set up in association with schools to detect any adverse events.  

In addition, acceptability studies are being organised in Ghana and Kenya. These will examine health worker and caregiver perspectives on the two approaches, as well as on different delivery methods – directly observed administration of albendazole, the new fixed-dose combination, or a three-day course with the final two doses taken at home.  

The project will also carry out modelling of different use cases and administration scenarios to assess their potential impact and cost-effectiveness. In addition, it is piloting an approach to monitor the emergence of resistance, based on genome sequencing of breakthrough infections detected in the study, which might indicate reduced drug susceptibility.  

The project will generate a package of evidence for policymakers and the WHO, which will be used to advocate for the introduction of the new fixed-dose combination. It will also coordinate submissions for regulatory approvals in Ghana and Kenya, which could form the basis for similar applications in other countries. In late 2025, the Ghana FDA became the first country to authorise the treatment for clinical and programmatic use. 

Impact

The STOP2030 project could have a major impact on the control of soil-transmitted helminths in sub-Saharan Africa. It will: 

• Generate evidence from real-world settings on the effectiveness and safety of the new fixed-dose combination.
• Provide a treatment option that is logistically simple to introduce or integrate into ongoing programmes but offers advantages over currently used drugs, having activity across a wider range of parasites.
• Deliver a package of evidence to facilitate regulatory approval and to support global and national policymakers’ decision-making. 

Ultimately, the albendazole–ivermectin fixed-dose combination could offer an improved option for controlling soil-transmitted helminths, providing broader protection and accelerating the elimination of diseases that affect many millions of people, especially children, in sub-Saharan Africa.