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.