Health Information and Monitoring of Sexually Transmitted Infections (SIM study): a single-center, parallel, three-arm randomized controlled trial protocol for enhancing adherence to syphilis treatment and follow-up

Abstract

Background: Syphilis has recently resurfaced as a significant public health problem. Since the 2000s, isolated syphilis outbreaks have increasingly occurred in North America, Europe, and Australia; in Brazil, there have been progressive increases in both congenital and acquired syphilis. There are several possible explanations, such as misdiagnosis of acquired syphilis, which could increase the number of untreated transmitters in the population; failure to initiate or complete treatment; and nontreatment of sexual partners (leading to reinfection). Mobile technologies have been successfully used to promote behavior changes and can positively impact treatment and follow-up adherence in patients with infectious diseases. The purpose of this clinical trial is to evaluate treatment and monitoring methods in patients with syphilis, including follow-up by telephone, via a game in a smartphone app, and at public health centers. Methods: The SIM study is a single-center, randomized controlled trial with a 12-month follow-up period. The aim is to identify the most effective method of follow-up regarding patient compliance with treatment. The tests will be performed in a mobile unit in easily accessible locations. The goal is to perform 10,000 rapid tests for syphilis. Patients with a confirmed diagnosis according to VDRL tests will be randomized to one of three arms: telephone, smartphone game, or conventional in-person follow-up. All analyses will follow the intention-to-treat principle. Conclusion: If we find differences in effectiveness, a major change in the conventional approach for this patient population may be needed, potentially affecting current Brazilian health policy strategies. Trial registration: NTC04753125. Version 1 of protocol 1/09/2020.