Periodic Reporting for period 1 - PvSTATEM (SEROLOGICAL TESTING AND TREATMENT FOR P. VIVAX: FROM A CLUSTER-RANDOMISED TRIAL IN ETHIOPIA AND MADAGASCAR TO A MOBILE-TECHNOLOGY SUPPORTED INTERVENTION)
Periodo di rendicontazione: 2022-10-01 al 2024-03-31
Context and overall objectives
Malaria eradication requires addressing all malaria species, including P. vivax that poses challenges to elimination efforts because of its dormant liver forms (“hypnozoites”). These forms can reactivate (“relapse infection”) causing illness and new transmission from people to mosquitoes, and they cannot be detected with traditional diagnostic methods.
The P. vivax Serological Testing and Treatment in Ethiopia and Madagascar (PvSTATEM) project aims to address this challenge.
We have developed a diagnostic test to identify people likely to carry hypnozoites. These people can be targeted for treatment with primaquine to clear hyponzoites and prevent relapse infection. This combination of a novel P. vivax serological test and the primaquine treatment provides a new intervention for malaria control and elimination; we call this intervention P. vivax Serological Testing and Treatment (PvSeroTAT). The four objectives of PvSTATEM are:
1) Assess the safety and efficacy of community-wide PvSeroTAT
2) Evaluate community acceptability of PvSeroTAT
3) Innovate mobile technologies for efficient implementation of PvSeroTAT
4*) Develop machine learning approaches for population-level malaria surveillance
*new objective since month 12
We aim to reduce malaria burden at both the individual and population level in two countries which experience the highest levels of P. vivax in Africa. We expect to have a significant effect in reducing morbidity and improving health. We will ensure community engagement and assess the adoption of new technologies that align with those existing in the health system. The proposal is built on equal partnership and shared capacity to address a substantial public health burden.
Malaria eradication requires addressing all malaria species, including P. vivax that poses challenges to elimination efforts because of its dormant liver forms (“hypnozoites”). These forms can reactivate (“relapse infection”) causing illness and new transmission from people to mosquitoes, and they cannot be detected with traditional diagnostic methods.
The P. vivax Serological Testing and Treatment in Ethiopia and Madagascar (PvSTATEM) project aims to address this challenge.
We have developed a diagnostic test to identify people likely to carry hypnozoites. These people can be targeted for treatment with primaquine to clear hyponzoites and prevent relapse infection. This combination of a novel P. vivax serological test and the primaquine treatment provides a new intervention for malaria control and elimination; we call this intervention P. vivax Serological Testing and Treatment (PvSeroTAT). The four objectives of PvSTATEM are:
1) Assess the safety and efficacy of community-wide PvSeroTAT
2) Evaluate community acceptability of PvSeroTAT
3) Innovate mobile technologies for efficient implementation of PvSeroTAT
4*) Develop machine learning approaches for population-level malaria surveillance
*new objective since month 12
We aim to reduce malaria burden at both the individual and population level in two countries which experience the highest levels of P. vivax in Africa. We expect to have a significant effect in reducing morbidity and improving health. We will ensure community engagement and assess the adoption of new technologies that align with those existing in the health system. The proposal is built on equal partnership and shared capacity to address a substantial public health burden.
Work performed and main achievements (M1-M18)
In the first 18 months of the project, the consortium performed the following activities and achievements per objective:
1) we identified relevant areas for the clinical studies in Ethiopia and Madagascar, we acquired ethics approval by the Sponsor and all local committees, we standardised our lab methods for sample analysis, and we initiated the clinical studies
2) we conducted rapid social sciences research into current community and health worker understandings of malaria and other local nosological categories associated with fever (e.g. symptoms, seasonality, local etiologies, local notions of immunity); related practices concerning diagnoses, treatment, and prevention; and expectations from the clinical studies in Ethiopia and Madagascar
3) we conducted collective intelligence workshops in Ethiopia and Madagascar to identify (a) barriers to effective testing and treatment of P. vivax malaria, (b) options for overcoming these barriers, and (c) user needs for the digital tool. We developed an mHealth Strategy to support design and implementation, and performed scoping visits to understand user requirements for the digital tool.
4*) we explored user needs to help develop the architecture and design of the software to be implemented.
In the first 18 months of the project, the consortium performed the following activities and achievements per objective:
1) we identified relevant areas for the clinical studies in Ethiopia and Madagascar, we acquired ethics approval by the Sponsor and all local committees, we standardised our lab methods for sample analysis, and we initiated the clinical studies
2) we conducted rapid social sciences research into current community and health worker understandings of malaria and other local nosological categories associated with fever (e.g. symptoms, seasonality, local etiologies, local notions of immunity); related practices concerning diagnoses, treatment, and prevention; and expectations from the clinical studies in Ethiopia and Madagascar
3) we conducted collective intelligence workshops in Ethiopia and Madagascar to identify (a) barriers to effective testing and treatment of P. vivax malaria, (b) options for overcoming these barriers, and (c) user needs for the digital tool. We developed an mHealth Strategy to support design and implementation, and performed scoping visits to understand user requirements for the digital tool.
4*) we explored user needs to help develop the architecture and design of the software to be implemented.
Results and impact (M1-M18)
Within the first 18 months we achieved the following results and impact by objective:
1) we completed the geospatial, ethical, and lab preparatory work, enabling initiation of the clinical studies. Notably we have completed an census studies in both Ethiopia and Madagascar, and completed the necessary preparations for sample collection in the baseline study. With the PvSeroTAT intervention that we will trial, we expect impact on reducing disease burden on patients (with associated improved quality of life, healthcare savings and increased productivity) and enabling health care providers to better tackle and manage malaria. The PvSTATEM clinical trial will also provide evidence for use case of P. vivax serological diagnostics as specified in the WHO Preferred Product Characteristics (PPC) for diagnosis of P. vivax malaria relapses.
2) we obtained insights on understandings of malaria and other nosological entities; practices associated with their diagnoses, treatment, and prevention; and expectations of upcoming clinical trials. These activities had both societal impact, in that they engaged local communities and individuals, and economic impact because the project hired local field assisants.
3) We used the collective intelligence data to inform an mHealth strategy, and we built an early version of the digital tool, with societal impact (local stakeholders providing their reflections, digital tool extending the reach of safe radical cure) and economic impact (simplified deployment to increase employability, digital tool development in Africa for an anticipated effect in the same region).
1, 2, 4*) we hired students from several consortium partners, including those in Ethiopia, Madagascar, and EU countries, and strengthened their research capacities.
*new objective since month 12
Within the first 18 months we achieved the following results and impact by objective:
1) we completed the geospatial, ethical, and lab preparatory work, enabling initiation of the clinical studies. Notably we have completed an census studies in both Ethiopia and Madagascar, and completed the necessary preparations for sample collection in the baseline study. With the PvSeroTAT intervention that we will trial, we expect impact on reducing disease burden on patients (with associated improved quality of life, healthcare savings and increased productivity) and enabling health care providers to better tackle and manage malaria. The PvSTATEM clinical trial will also provide evidence for use case of P. vivax serological diagnostics as specified in the WHO Preferred Product Characteristics (PPC) for diagnosis of P. vivax malaria relapses.
2) we obtained insights on understandings of malaria and other nosological entities; practices associated with their diagnoses, treatment, and prevention; and expectations of upcoming clinical trials. These activities had both societal impact, in that they engaged local communities and individuals, and economic impact because the project hired local field assisants.
3) We used the collective intelligence data to inform an mHealth strategy, and we built an early version of the digital tool, with societal impact (local stakeholders providing their reflections, digital tool extending the reach of safe radical cure) and economic impact (simplified deployment to increase employability, digital tool development in Africa for an anticipated effect in the same region).
1, 2, 4*) we hired students from several consortium partners, including those in Ethiopia, Madagascar, and EU countries, and strengthened their research capacities.
*new objective since month 12