A clinical utility evaluation of dual HIV/Syphilis point-of-care tests in non-clinical settings for screening for HIV and syphilis in men who have sex with men.

"Declarations Ethics approval and consent to participateThe study has been independently peer reviewed and approved by the Research Project Review Panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research (SRH) and by the WHO Ethics Review Committee (ERC), and by ethics committees in each country. Autonomy of the users to decide to participate in the study was safeguarded by the division of the roles of taking pre-consent on the one hand and performing the study on the other. The final consent was taken by the CBO testing service provider who performs the test, as they also checked if the user met the inclusion criteria, for confidentiality reasons. Consent for publicationNot applicable. Competing interestsThe POCT manufacturers furnished sufficient quantities of the product(s) free of charge in order to enable this evaluation as part of the WHO/RHR STI POC initiative. WHO is entitled to evaluate and publish the trial results, and to exclusively control this evaluation and the content of the publication. WHO shall submit any proposed publication to the manufacturers for review, comments received will be considered in good faith, but the decision to publish rests with WHO. Competing interests The POCT manufacturers furnished sufficient quantities of the product(s) free of charge in order to enable this evaluation as part of the WHO/RHR STI POC initiative. WHO is entitled to evaluate and publish the trial results, and to exclusively control this evaluation and the content of the publication. WHO shall submit any proposed publication to the manufacturers for review, comments received will be considered in good faith, but the decision to publish rests with WHO."

"Funding This work was funded by the UNDP- UNFPA- UNICEF- WHO- World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a co-sponsored programme executed by the World Health Organization (WHO). Since this project was funded by WHO, only in low- and middle-income countries, relevant WHO technical staff provided technical contribution to all these activities as members of the Global Coordinating Team of the project. Award/Grant number is not applicable."