Background A huge number of people living with HIV / AIDS lives in developing countries. Thus, strengthening health systems in these countries is a prerequisite for improving disease prevention and care. After three decades of HIV/AIDS policy-making in Iran, conducting a comprehensive analysis on the policy process seems to be essential. In the present study, we aimed to analyse the HIV/AIDS policy-making process in Iran from 1986 to 2016. Methods This was a theory-based, multi-method and retrospective study. Interviewing of key informants and review of policy documents were concurrently conducted to identify and include further key informants (39 participants) and documents in the study. Framework analysis was used to analyse data. Results The mean age of participants working in HIV/AIDS policy-making was of 48 years and participants had a mean of 14 years of working experience. Findings were categorized as contextual factors, content of HIV/AIDS policies, actors involved in the policy process, and evidence use in the policy process. Contextual effective factors on the HIV/AIDS policy-making process were categorized into five major themes, namely situational factors, structural-managerial factors, socioeconomic factors, political and legal factors, and international factors. The HIV/AIDS phenomenon in Iran was identified to be deeply rooted in the culture and traditions of society. The HIV/AIDS policy content has, recently, been crystallized in the national strategic plans and harm reduction policies of the country. The policy process has been conducted with a solely governmental top-down approach and is now suffering from poor evidence and lack of sufficient consideration of contextual factors. Conclusions There is a great need for change in the approach of government towards the issue and to increase the participation of non-governmental sectors and civil society in the policy process.

Introduction: HIV/AIDS phenomenon is one of the most serious public health challenges which includes wide range of epidemiological, social, economic and political dimensions. Therefore, its effective control requires involvement of different stakeholders. The present study aims to identify and analyze HIV/AIDS stakeholders in Iran.Methods: This qualitative stakeholder analysis was conducted in 2018 nationwide both retrospectively and prospectively. Identification and analysis of stakeholders was carried out by the review of related literature and policy documents and official websites, as well as holding semistructured interviews with policy makers and other key informants. Purposive sampling was utilized and followed by snowball sampling until data saturation. Data were analyzed using framework analysis. Also, qualitative data analysis software MAXQDA (Version 11) and Policy Maker software (version 4) were applied. Findings: A total of 44 stakeholders were identified and categorized into 23 active and 21 inactive stakeholders. Despite the great importance of educating and informing pubic about HIV/AIDS, the Ministry of Education and Islamic Republic of Iran Broadcasting organization (IRIB), have moderate participation in this regard. Supreme Council of Health and Non-governmental organizations (NGOs) have low participation. The Ministry of Health and Medical Education (MoHME), State Welfare Organization of Iran, Iranian Blood Transfusion Organization, the State Prisons and Security and Corrective Measures Organization are interested in HIV/AIDS policymaking. The MoHME, as main body responsible for stewardship of the HIV/AIDS in Iran, does not have enough authority in handling the issue due to the low funding, institutional and structural deficits and insufficient human resources. Conclusion:The process of HIV/AIDS policy making is fragmented in Iran and despite multiple active and passive stakeholders in this field, there is no integrated system to involve all stakeholders in the process of AIDS policy-making. Therefore, given the importance of the issue, an upstream entity is needed in order to coordinate and mobilize all stakeholders associated with managing and controlling HIV/AIDS.