OBJECTIVES:Most Heath-Related Quality of Life (HRQL) questionnaires specific to HIV/AIDS were developed when HIV was a deadly disease. They do not adequately measure the impact of the disease and its treatment on People Living With HIV/AIDS (PLWA) anymore. Relevant domains are missing such as perception about treatment, impact of side effects, lipodystrophy and sleep. Psycho-social impact, especially stigma, is under-evaluated. The objective is to develop a new Patient-Reported Outcomes (PRO) questionnaire to measure the HRQL of PLWA in different countries using an item bank developed with patients. METHODS:The conceptual framework was identified on the basis of patients’ interviews. To capture the cultural differences in patients’ perceptions, the interviews were held in the five continents: Africa (Senegal), America (Brazil, USA), Australia, Asia (Thailand, China, Cambodia, India) and Europe (France). All interviews were recorded, transcribed and translated into English or French. Important verbatim were selected, transformed into items and organized into a questionnaire developed in French and in English. ). All interviews were recorded, transcribed and translated into English or French. Important verbatim were selected, transformed into items and organized into a questionnaire developed in French and in English. RESULTS: A total of 148 patients were interviewed (47% women), and PRO concepts important to the patients were identified. An endpoint model was designed to explain the relations between PROs: health status, symptoms, side effects and HRQL domains. Cultural differences were identified in daily activities, stigma and relations with family and friends. 300 items were generated in French and in English and organized into a 24-domain item bank. Item reduction to a 70-item questionnaire was done with experts. Full linguistic validation process was performed. CONCLUSIONS:A new PRO questionnaire specific to HIV was developed. The international development from an early step will enable a better cultural relevance and has improved the translatability of the source questionnaires (French and English) into the target languages. The international psychometric validation study with 900 patients is ongoing.