Global collaboration action towards better prevention, treatment and clinical management of HIV co-infections or co-morbidities in sub-Saharan Africa

Expected Impact:

Expected Impact

Projects funded under this topic should contribute towards the reduction of the burden of disease in sub-Saharan Africa and thus contribute to achieving SDG 3 ‘Ensure healthy lives and promote well-being for all at all ages’ through increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investment.

Proposals are expected to include the effective in-kind and/or financial contribution of contributing partners, in order to produce more meaningful and significant effects enhancing the impact of the related research activities.

Applicant consortium

The contributions from contributing partners should correspond to the amounts they have committed in the letter of endorsement requesting to become a contributing partner (Article 9 Council Regulation (EU) 2021/2085^[1]). Their contributions can consist of financial contributions and/or in-kind contributions. Applicant contributing partners must submit a first draft of the endorsement letter to the Programme Office before the deadline for submission of the second-stage applications^[2]. For details on the process on becoming a Global Health EDCTP3 contributing partner, please consult the Guide for contributing partners.

In case of in-kind contribution (even combined with financial contribution), contributing partners become a part of the applicant consortium and participate in the project, as appropriate i.e. as beneficiaries or affiliated entities in the meaning of Article 8 of the Horizon Europe model grant agreement. Also, Global Health EDCTP3 contributing partners can be a country, an international organisation or any public or private legal entity, other than the Global Health EDCTP3 members or their constituent or affiliated entities, please consult the Guide for contributing partners.

Expected Outcome:

Background

Despite the shifting global health research funding landscape and resources increasingly being re-focused to other emerging (health) priorities, HIV continues to be a major driver of morbidity and mortality, particularly in sub-Saharan Africa (SSA) that is home to nearly 70% of all people living with HIV worldwide. A growing challenge for this region is the increasing number of people living with HIV and related co-infections and co-morbidities. This includes people living with HIV who are infected with another infectious pathogen (in particular but not limited to tuberculosis, malaria, genital schistosomiasis, hepatitis and human papillomavirus) as well as people living with HIV having a non-communicable disease (NCDs), in particular but not limited to cardiovascular diseases and diabetes. HIV co-infections and co-morbidities are typically associated with polypharmacy which complicates treatment decisions, increases the serious risk of drug-drug interactions and influences the effectiveness or safety of treatments. According to the World Health Organization^[3], 73% of all NCD deaths are in Low- and Middle-Income Countries (LMICs) making NCDs a major cause of mortality. There is therefore an urgent need to improve prevention, treatment and clinical management of people living with HIV and related co-infections and co-morbidities by accelerating clinical research for new/improved (combination) products and clinical management practices. Given the importance of patient-centred approaches to healthcare, studies examining how prevention or treatment of non-communicable diseases can be integrated into models of care established for the management and treatment of HIV are essential.

Expected Outcomes

Proposals submitted under this topic should aim for delivering results that are directed, tailored towards and contributing to ALL of the following expected outcomes:

1. Improved prevention and/or treatment outcomes for co-infection(s) or co-morbidity/ies to HIV in SSA.
2. Better integration of healthcare services and support programs related to HIV co-infection(s) or co-morbidity/ies for people living with HIV in different healthcare systems in SSA.
3. Improved management of people living with HIV and related co-infection(s) or co-morbidity/ies, particularly safer polypharmacy use.
4. Enhanced and informed public health management decision-making by policy makers and public health authorities with regards to people living with HIV and related co-infection(s) or co-morbidity/ies.

Scope:

Scope

The proposals submitted under this topic should generate evidence on efficacy, immunogenicity, safety and/or clinical utility for healthcare professionals and clinicians in SSA of novel/improved products that aim to improve prevention and/or treatment outcomes for a co-infection or co-morbidity to HIV.

This includes the prevention of developing HIV co-morbidities or advanced HIV disease (as per WHO definition^[4]). Proposals should address effective service integration in different healthcare systems in SSA, including safer polypharmacy use.

The proposals submitted under this topic should address late-stage (phase IIb and thereafter) clinical development.

The target population is people with HIV, including advanced HIV disease associated with co-morbidities and patients on long term HIV treatment (including antiretroviral and HIV control). Except for Tuberculosis (covered in other call for proposals), all infectious diseases and co-morbidities in this target population are within the scope of this topic. The clinical research may also include advanced HIV disease associated with co-morbidities. Existing high-risk co-morbidities and those attributed to the use of medications or other interventions to treat HIV are also in scope.

The research can be conducted in any age group, but it should be inclusive when relevant and ensure the participation of vulnerable research participants, for example but not limited to people living with HIV having impaired organ function. Social and societal dimensions including strategies for social inclusion and stigma mitigation are to be considered. Sex and gender differences and the effects of age should be duly taken into account when relevant. For Phase III studies, applicants are encouraged to ensure adequate statistical power for sex/gender- and age-specific analyses when relevant.

The proposals should address how the generated data will support public health authorities and policy makers to inform updated evidence-based clinical guidelines and design relevant HIV policies.

Cost-effectiveness and implementation research is within the scope of this topic, especially in the context of new innovations such long acting injectables and monoclonal antibodies. For long-acting injectables and monoclonal antibodies in particular, the implementation research should consider cost-effectiveness studies or other activities to make interventions affordable and accessible.

Epidemiological and surveillance studies with new cohorts and development or evaluation of diagnostics are out of scope of this topic. However, the continuation of surveillance of existing cohorts and the use of diagnostics as part of the standard of care when relevant is permissible.

The prevention and treatment of a HIV infection itself or clinical management exclusively focusing on HIV infection is also out of scope of this topic. The assessment of HIV parameters developing interventions for co-infections or co-morbidities or in clinical management is in scope.

Preclinical studies are considered out of scope of the topic.

However, preparatory activities conducted during the preclinical phase can be considered in scope if they enable the conduct of the clinical study/ies in scope (these activities include but are not limited to protocol writing, development/evaluation of laboratory tests, CMC related activities, etc.).

For all Global Collaboration Actions such as this topic, proposals submitted are expected to leverage financial and/or in-kind contribution from contributing partners. Proposals should define the activities of their project in its entirety, including details of the component(s) for which Global Health EDCTP3 funding is requested and the component(s) that are to be financed by contributing partners. Each contribution should be well described and budgeted in each proposal, so that the activities and related costs that are covered by the in-kind or financial contribution(s) are clearly identified.

Where possible, collaboration and coordination with the AU-EU Health Partnership’s Manufacturing and Access to Vaccines, medicines and health technologies (MAV+) hub is encouraged. The proposers 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.

When relevant, proposals should clearly describe the desired target product profile. Applicants need to concisely describe any prior relevant research findings and explain how the proposal builds on available data (including data generated in scope of earlier EDCTP programmes if available). Full details of the development milestones, including specific go/no-go criteria for the implementation of the proposed clinical trial(s) must be included, as well as specific plans for the subsequent regulatory approval process, which should aim at obtaining relevant market authorisation and an access strategy that will allow patients in low-resource settings to access the final product.

The applicants are encouraged to consider the latest innovations and advances in the clinical trial design and research methods in order to evaluate promising interventions allowing shorter development timings.

Proposals should engage communities and relevant stakeholders, most notably (local) key opinion leaders, researchers, healthcare professionals, policy makers, public health authorities and end-users. Applicants should provide methodologies for translating research findings into public health practice and policy guidelines and are encouraged to follow guidance provided in the EDCTP Knowledge Hub Research into Policy Toolkit.

Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from SSA countries, including involvement of Franco/Lusophone countries, if possible. Collaboration with other international research groups with relevant experience is very much encouraged. Applicants are also reminded of the expectation of reaching out to organisations in countries with relatively lower research capacities.

All projects funded under this topic are strongly encouraged to participate in networking and joint activities, such as external conferences, workshops or symposia for an exchange of knowledge, and best practices with external collaborators.

[1] Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014

[2] The Global Health EDCTP3 Programme Office will ask the applicant contributing partner to revise the letter in case it significantly departs from the template letter published on the Global Health EDCTP3 website or is missing any compulsory elements. The final decision as to acceptance or rejection of a new contributing partner rests with the Global Health EDCTP3 Governing Board.

[3] WHO website –- Noncommunicable diseases fact sheet (23 December 2024)

[4] WHO | Global HIV Programme