I-COUNT: Inclusion, Community Outreach and Understanding for New Therapies
Equity and access for marginalized groups in HIV treatment and cure research - Enhancing the participation of marginalized groups in HIV cure research
Introduction
The inclusion of marginalized groups in clinical research is essential—not only for ethical reasons but also to enable meaningful progress in HIV cure research. Genuine advances in the field depend on ensuring diverse representation.
The term “marginalized groups” varies by region but generally refers to populations disproportionately affected by HIV due to intersecting social, economic, and systemic inequalities. These include ethnic minorities, people with disabilities, individuals who inject drugs, sex workers, transgender individuals, women, and, in some contexts, men who have sex with men (MSM).
This project focuses particularly on transgender and non-binary (TNB) communities. According to TGEU’s (Trans Europe and Central Asia) Transgender Europe 2025 report, setbacks in trans rights across Europe and Central Asia now outweigh progress for the first time in 13 years. Globally, rising threats from transphobic and restrictive policies are undermining trans identities and limiting access to gender-affirming care. TNB communities often face intersecting forms of marginalization and systemic barriers, including criminalization, limited access to healthcare, unstable housing, and threats to personal safety. These challenges are further exacerbated by discrimination and violence.
This community experiences disproportionately high rates of HIV. Transgender women, in particular, are 49 times more likely to be living with HIV than the general population. Their estimated risk of acquiring new infections is 20 times higher. Despite these alarming statistics, they face some of the worst health outcomes and remain significantly underrepresented in research. To date, only 55 transgender individuals have been included globally in HIV cure studies.
Problem Statement and Current Research Status
This project aims to:
- Understand the current state of inclusion of marginalized communities in HIV cure research.
- Identify barriers, motivations, and existing measures to foster participation.
- Summarize these findings to develop a standardized procedure that enhances motivation, active engagement, and participation of TNB individuals in HIV cure and treatment research.
- Examine the role of education and science communication in enabling participation.
The long-term goal is to establish an inclusive infrastructure for active engagement in the development of research questions, the design and review of studies, and inclusion in studies, which can later be adapted to other marginalized populations.
Project Description
Goal 1 – Co-Develop and Implement Assessment Tools
- Community Assessment Tool: Co-create and implement tools to assess the needs, experiences, and willingness of TNB individuals to participate in HIV research. These tools will consider socio-economic factors such as satisfaction with care, experiences of stigma and discrimination, and syndemic conditions that influence healthcare access and research participation.
- Creation Process: The tool development is informed by qualitative focus groups and interviews with community members and organizations in Europe and Latin America. These conversations explore key barriers and structural determinants. Insights gained directly inform the design of a context-sensitive questionnaire aimed at capturing community needs, priorities, and the behavioral and environmental factors that shape participation.
- Preliminary Findings: Initial insights highlight several barriers to participation, including the absence of TNB representation within research teams, mistrust in institutions due to past negative experiences, limited awareness of HIV cure research, and competing life priorities such as economic survival. The findings also reveal unmet biomedical needs and social determinants that affect willingness to participate in research.
- Next Steps: Using data from the questionnaire, the project will apply intervention mapping to develop an inclusive logic model and participation framework. This model will be designed to increase research participation by addressing barriers, promoting health equity, and centering TNB voices, lived experiences, and leadership.
- International Implementation: The tool will be piloted in diverse settings—including Paris, Buenos Aires, and across Europe and Central Asia in collaboration with TGEU—to ensure its adaptability and global relevance.
- Research Group Questionnaire: A complementary survey will be developed for HIV cure research teams globally to examine how they identify, reach, and work with marginalized populations. This questionnaire will explore motivations, challenges, and effective strategies, contributing to a practice-oriented framework for more inclusive research.
Goal 2 – Create and Evaluate Participatory HIV Explanatory Videos & AI-Powered Chatbot
- Science Communication: Develop accessible, community-informed media to enhance health literacy and participation in HIV cure and treatment research.
- Feedback Rounds: Conduct iterative testing and feedback sessions to ensure the clarity, relevance, and cultural sensitivity of these materials for international audiences.
Goal 3 – Conduct Exit Interviews
- Participant Feedback: Conduct exit interviews with participants in ongoing clinical studies, such as KOHIVI, a longitudinal observational study investigating the effects of gender-affirming hormonal therapy (GAHT) on HIV persistence and immune response.
- Improve Research Practices: Use insights from these interviews to improve study design, participation experience, and community trust.
Implementation and Impact
Strategies developed through I-COUNT will be implemented at our research center in Berlin to improve both current and future studies. Results and best practices will be shared with research groups globally to advance more inclusive, ethical, and effective HIV cure research.
About Gaebler Lab
About Gaebler Lab
About Gaebler Lab
Our research group is establishing BeCURE – Berlin Center for HIV Cure, with plans to engage a community advisory board and host regular community events. Past events include panel discussions with Berliner AIDS-Hilfe on cure research, a panel at Village on loneliness among people living with HIV, a World AIDS Day fundraiser for TransSexworks at Movimento, Trans Day of Remembrance at BIH and Charité, and lectures at AK AIDS and Checkpoint BLN – Nachtcafé.
We are proud to be part of the Fast-Track Cities Network Berlin, working to promote prevention, testing, and shared decision-making, combatting stigma, and contributing to achieving the UNAIDS goals.
For more information, please see here.