Belong Public Consultation | Clinical Trial Eligibility Criteria for Participants with HIV: Guidance on Improving Inclusion in Non-HIV Trials

As people living with HIV live longer lives due to effective treatment, when accessible, they increasingly experience health conditions common to the general population. However, people living with HIV are often arbitrarily excluded from clinical research investigating innovative treatment for these conditions.

To address this issue, the European AIDS Treatment Group (EATG) launched the Belong project in 2022. Its goal is to advocate for the adoption of clinical guidelines by regulatory authorities across Europe to support the inclusion of people living with HIV in clinical trials for illnesses beyond HIV.

As a first step, EATG published a position paper entitled Why people living with HIV must be included in non-HIV clinical trials. The current phase of the Belong project focuses on the development of clinical guidelines in collaboration with a wide range of stakeholders.

As part of the development process, EATG is now seeking input on a draft guidance intended to help clinical research stakeholders including sponsors (industry and not-for-profit), investigators, ethics review board and regulatory authorities, in the development, conduct and oversight of clinical trials.

Who are we calling to participate in the consultation?

We invite private and public product developers, scientists, affected communities, patient advocates and clinical research professionals, both within and beyond the HIV field, to review the draft guidance document Clinical Trial Eligibility Criteria for Participants with HIV: Guidance on Improving Inclusion in Non-HIV Trials and share their feedback by the 22^nd of August 2025.  1st of September 2025.

How to send your feedback

1. Open the protected editable Word document found here and via the Materials widget. (downloads automatically)
2. Read the draft.
3. Add your details and feedback in the designated fields.
4. Once completed, please return it via e-mail to the address stated on the document.
5. If you are open to being contacted for further input or discussion, please inform us in your return e-mail and share your contact details with us.

Thank you in advance for any input you may provide.

By working together, we can ensure that the inclusion of people living with HIV in non-HIV clinical research supports global efforts to empower patients, democratise the research process, and expand access to life-saving medicines.