Interventions for Enhancing Adherence to Syphilis Treatment and Follow-up: Study Protocol for the Health Information and Monitoring of Sexually Transmitted Infections (SIM) Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 主要终点
- complince of treatment
研究概览
简要总结
The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance. The recruitment of participants will be done by invitation, and tests will be performed in a mobile unit in locations accessible to large populations. The goal is to perform 10,000 quick tests, with results confirmed by venereal disease research laboratory (VDRL) tests. Patients with a confirmed diagnosis according to VDRL test results will be randomized in one of three monitoring arms: follow-up by telephone, follow-up via a game in a smartphone app, or conventional follow-up by a health professional. All analyses will follow the intention-to-treat principle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adults aged 18 years and older with sorologic test positive for syphilis
排除标准
- •Participants who did not return after three contact attempts will be excluded from the study,
- •pregnant women
- •participants who are not able to provide contact information
- •participants who are illiterate
- •participants those who underwent syphilis treatment within the previous three months.
结局指标
主要结局
complince of treatment
时间窗: ut to 12 months (July 2023)
3 doses of penicillin g benzathine 3,000,000 UI. The injections are given in the gluteal region once a week from the first dose.
complince of exams
时间窗: up to 12 months (July 2023)
Performing the VDRL blood test that should be done at 3, 6, 9 and 12 months after treatment with penicillin.
次要结局
- identify behavioral risk factors for non-adherence to treatment(upt to 12 months (July 2023))
研究者
Vanessa Martins de Oliveira
Prof Eliana Marcia Ross Wendland
Hospital Moinhos de Vento