Belong – Inclusion of People living with HIV in non-HIV clinical trials

Why?

As people living with HIV live longer lives, they may experience non-HIV-related health conditions and illnesses that affect the general population but that can affect them more than the general population. However, there is a lack of safety and efficacy data on the treatment for these non-HIV ailments in people living with HIV. This information is missing because people living with HIV have historically been excluded from clinical research of potentially life-extending or life-saving drugs and treatments for these illnesses and comorbidities.

The inclusion/exclusion criteria for participation of people living with HIV in non-HIV clinical research has been an ongoing discussion, exacerbated by recent COVID-19 vaccination trials, which initially excluded people living with HIV. Exclusion criteria are based on clear scientific or clinical rationale which are non-negotiable in clinical trials, and there is concern from the HIV community that the ongoing cases of restrictive eligibility criteria without such rationale, often applies to people living with HIV.

As pointed out by the FDA, this may “limit patients’ access to clinical trials and lead to trial results that do not fully represent treatment effects in the patient population that will ultimately use the drug” (FDA Guidance on Cancer Clinical Trial Eligibility Criteria). HIV is now considered a chronic and manageable condition when appropriate treatment is available, so the rationale to exclude people living with HIV, based solely on their HIV status is lacking. Yet, this is often common practice in most studies of investigational drugs.

In this respect, in 2022, EATG developed a position paper detailing ‘Why people living with HIV should be included in non-HIV clinical trials’.

What?

Moving from the EATG position paper, the overall goal of this project is to advocate for regulatory authorities in Europe to adopt clinical guidelines that include people living with HIV in trials relating to other illnesses and health conditions that affect people living with HIV.

The BELONG project will be developed in two phases. Phase One, covered in 2023, aims to complete all of the research and groundwork for the creation of the guidelines. Strategies will be developed, partnerships will be identified and solidified. In addition, the project will build a case study based of a series of previous EATG meetings, which took place in Sitges (Spain, 2007-2017) and resulted in successful stakeholder collaboration and approval of a set of guidelines to include people living with HIV/HCV co-infections in essential HCV drug treatment trials. By documenting this meeting, EATG will reflect on the lessons learned and create a plan to replicate this model of meeting to achieve the BELONG objectives, while ensuring the centrality of the community in each task.

With whom?

The project will bring together people living with HIV, patient organisations, clinical societies, regulatory agencies and industry partners. Exact partners will be defined during the first steps of the project, where extensive research and mapping of stakeholders from both the HIV and other disease areas will be undertaken. In addition, it will be implemented in close collaboration with an ad-hoc Community Advisory Group (CAG) composed of EATG members.

The project primarily aims to benefit the community of people living with HIV. Specific attention will be given to the inclusion of underrepresented communities in medicine research such as women and transgender people. Collaboration with communities from other disease areas is intended to benefit the community of patients at large.

How?

Project activities will include:

• Planning, coordination and community engagement through the development of a strategy plan (including communication strategy, policy strategy, engagement strategy, with a focus on inclusion and diversity, and M&E strategy) and creation of a Community Advisory Group (CAG).
• Targeted dissemination of the position paper through varied communication channels and including a kick-off multi-stakeholder e-meeting to raise awareness of community needs.
• Partnership development and engagement through mapping and outreach of HIV-related stakeholders and stakeholders in other relevant disease-areas (e.g. patient organisations, industry, regulatory agencies, clinical societies).
• Mapping, research and multimedia content production to build a case study on the past EATG experience of the Sitges meetings. A publication to better understand community needs will be created with recommendations for replication, future exploitation and lessons learned on successful community advocacy to influence policies and clinical trials.
• Application of the Sitges Model to BELONG: planning of a multi-stakeholder meeting for Phase 2.
• Stakeholder and Community Advisory Group engagement assessment and project evaluation, with recommendations for Phase 2.

For what outcome?

With this project, EATG aims to:

• Ensure the early and continual engagement of people living with HIV in clinical research development and in the implementation of inclusive clinical research guidelines toward improving health outcomes for people living with HIV and other comorbidities.
• Contribute to discussions in Europe and elsewhere towards the revision of Good Clinical Practice Guidelines that encourage all people living with a health condition to fight for their right to be part of clinical research whose outcomes may benefit their treatment and care.
• Construct a case study based on EATG previous experience with the Sitges Meetings as a successful example of community advocacy to inform policy and services to meet community needs. The Sitges Meetings Model will be replicated and applied to the development of guidelines for the inclusion of people living with HIV in non-HIV clinical trials (Phase 2 of BELONG).
• Advocate for more inclusive eligibility criteria to be adopted by European countries and regulated by national and supranational regulatory agencies, emphasising the importance of diversity in non-HIV clinical trial recruitment, including transgender people and women living with HIV.
• Foster collaboration between people living with HIV, regulatory agencies and trial sponsors in the drug development process and develop cross-cutting partnerships among different disease areas to conduct joint advocacy efforts for inclusion of non-exclusion criteria in international guidelines and regulations, discussing why the systematic exclusion cannot be justified.