BackgroundColombia’s universal health coverage programme has enrolled 98% of the population, thereby improving financial protection and health outcomes. The right to participate in the organisation of healthcare is enshrined in the 1991 Colombian Constitution. One participatory mechanism is the legal and regulatory provision that citizens can form user associations. This study examines the functionality of health insurance user associations and their influence on citizen empowerment and health insurance responsiveness.MethodsThe mixed methods study includes document review (n=72), a survey of beneficiaries (n=1311), a survey of user associations members (n=27), as well as interviews (n=19), focus group discussions (n=6) and stakeholder consultations (n=6) with user association members, government officials, and representatives from insurers, the pharmaceutical industry, and patient associations. Analysis used a content–process–context framework to understand how user associations are designed to work according to policy content, how they actually work in terms of coverage, public awareness, membership, and effectiveness, and contextual influences.FindingsColombia’s user associations have a mandate to represent citizens’ interests, enable participation in insurer decision-making, ‘defend users’ and oversee quality services. Insurers are mandated to ensure their enrollees create user associations, but are not required to provide resources to support their work. Thus, we found that user associations had been formed throughout the country, but the public was widely unaware of their existence. Many associations were weak, passive or entirely inactive. Limited market competition and toothless policies about user associations made insurers indifferent to community involvement.ConclusionCurrently, the initiative suffers from low awareness and low participation levels that can hardly lead to empowered enrollees and more responsive health insurance programmes. Yet, most stakeholders value the space to participate and still see potential in the initiative. This warrants a range of policy recommendations to strengthen user associations and truly enable them to effect change.