ExpectedOutcome:
This topic aims at supporting activities that contribute to one or several of the expected impacts for this call. To that end, proposals submitted under this topic should aim for delivering results that are directed, tailored towards and contributing to at least two of the following expected outcomes:
- Evidence of efficacy, safety and clinical utility for health care professionals and clinicians in sub-Saharan Africa about novel, targeted HIV therapeutics that improve treatment outcomes and quality of life;
- Innovative HIV therapeutics that have demonstrated meaningful advances over existing therapeutic interventions for patients living with HIV in terms of their ability to improve efficacy, safety, adherence, quality of life and reduce HIV-associated mortality and morbidity.
- Public health authorities and policy makers have information from comprehensive clinical trial data on the overall health effects of novel therapeutic HIV interventions, helping them to draft updated or new evidence-based clinical guidelines and best practices as well as design tailor-made HIV policies.
Scope:
Background:
Over the last few decades, antiretroviral therapy has dramatically increased the life expectancy of HIV patients, turning HIV from a death sentence into a chronic illness. Nevertheless, there are currently around 39 million infected people around the globe and HIV remains a major cause of death, disability and ill-health. The HIV disease burden continues to be high in sub-Saharan Africa, in particular for children and adolescents, and those with co-morbidities. There is therefore a strong need to achieve the 2030 UNAIDS 95-95-95 target[1] (95% of people with HIV know their HIV status; 95% of people with diagnosed HIV infection receive antiretroviral therapy; 95% of people receiving antiretroviral therapy have effective viral suppression) and develop novel HIV therapeutics, novel clinical delivery modes for their administration and novel biomarkers for optimising treatment decisions.
Scope:
Accordingly, the proposed research must deliver on the following:
- Carry out advanced stage clinical trials of promising HIV therapeutic interventions, for example but not limited to broadly neutralising antibodies, long-acting antiretrovirals or gene therapy approaches.
It may additionally also include:
- Creation and testing of novel clinical delivery routes for the administration of HIV therapeutic interventions that bring meaningful benefit for HIV patients in terms of safety, efficacy, adherence and quality of life;
- In the context of the planned clinical investigations, identification and validation of biomarkers for better optimisation and personalisation of HIV treatment decisions as well as more accurate predictors of progression towards AIDS.
Applicants need to concisely describe any prior research findings and explain how the proposal builds on these results.
Proposals must carry out late-stage clinical research. Implementation research is not in scope for this topic. The research to be conducted must be inclusive and involve vulnerable groups, in particular infants, children and adolescents. Applicants are further encouraged to involve populations with limited clinical trial data, as well as HIV patients with co-infections and co-morbidities, both of which are associated with polypharmacy and present a serious risk for drug-drug interactions. Sex and gender differences and the effects of age should be duly taken into account.
Proposals should engage all relevant stakeholders, most notably researchers, health care professionals, policy makers, public health authorities and end-users. Applicants should provide methodologies for translating research findings into public health practice and policy guidelines.
Where possible, collaboration and coordination with the Team Europe Initiative on Manufacturing and Access to Vaccines, medicines and health products (TEI-MAV+) is encouraged. The applicants could show, for example, willingness to enter into technology transfer agreements with African counterparts - including the provision of patents, technical knowledge and know-how -, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.
Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from sub-Saharan African countries, including involvement of Franco/Lusophone countries if possible. Collaboration with other international research groups developing HIV therapeutics is very much encouraged. Applicants are also reminded of the expectation of reaching out to organisations in countries with relatively lower research capacities.
[1] Joint United Nations Programme on HIV/AIDS (UNAIDS). (2014). Fast-Track: ending the AIDS epidemic by 2030. https://www.unaids.org/sites/default/files/media_asset/JC2686_WAD2014report_en.pdf
Expected Impact:
Activities funded under the 2024 work programme of the Global Health EDCTP3 JU calls for proposals should contribute to:
- reduce the individual, social, and economic burdens of infectious diseases in sub-Saharan Africa through the development and uptake of new or improved interventions, and
- increase health security in sub-Saharan Africa and globally by reducing the risk of outbreaks and pandemics and enhancing national and regional capacity to address antimicrobial resistance.
- Progressing towards the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African (SSA) countries;
- Enable the implementation of the short- and medium-term actions foreseen by the AU EU Innovation Agenda (adopted in July 2023) in the area of public health and the EU Global Health Strategy (November 2022);
- Improve equitable access to a full range of essential health services from health promotion to disease prevention and affordable quality treatment, rehabilitation and palliative care to fight communicable diseases;
- Expand partnerships based on equal footing, co-ownership, mutual interest and strategic priorities;
- Provide evidence for informed health policies and guidelines within public health systems in SSA and at international level;
- Enhance sustainable global scientific collaboration in health research and international cooperation across SSA;
- Develop novel, innovative HIV therapeutics for reducing the disease burden of HIV in SSA
- Research on existing Malaria vaccines and development of new promising candidates
- Accelerating development and integration of therapeutics against neglected tropical diseases (NTDs) in SSA;
- Tackle Antimicrobial Resistance (AMR) through R&D in novel and existing antimicrobials
- Develop new tools, technologies and approaches for vector control in SSA;
- Develop innovative digital health solutions for SSA.
- Build appropriate local capacity.
