A community-level RCT of expedited partner treatment for gonorrhea and chlamydia

描述(申请人提供)：淋球菌和沙眼衣原体是美国最常见的两种细菌性性传播感染(STI)，估计每年影响400万人，成本超过30亿美元。在经历了一段时间的发病率下降后，衣原体感染的流行率现在在美国的一些地区正在上升，而淋病的发病率保持稳定，但不再下降。需要采取新的公共卫生干预措施，以减少这些感染的发病率。改善合作伙伴的通知和待遇可能就是这样一种干预。最近的随机对照试验表明，快速伴侣疗法(EPT)可以增加淋病或衣原体感染患者的性伴侣数量，并可以降低STI的再感染率。EPT是一种在没有临床医生强制事先检查的情况下治疗可治愈的STI患者的性伴侣的做法。研究调查人员表明，可以在一个城市建立公共卫生EPT计划，以增加合作伙伴的治疗，但还没有建立更大规模的公共卫生EPT计划的可行性，更大的EPT计划在人口层面的影响和成本效益也是未知的。这项申请提出了华盛顿州EPT治疗淋病和衣原体感染的阶梯式社区水平随机对照试验。一项以人口为基础的EPT计划将仿照华盛顿州国王县已经实施的计划，以随机选择的时间顺序在华盛顿州的28个卫生区建立。将向患者提供免费药物，以便向他们的性伴侣提供服务，新的病例报告表将对未通知伴侣的高危人群的公共卫生伙伴通知援助进行分类。免费药物将通过每个卫生区的较大诊所和参与该计划的商业药房网络直接分发给患者。这项研究将评估EPT对接受CDC不孕预防项目资助的诊所中接受测试的妇女中衣原体感染流行率的影响，以及对该州妇女报告的淋病发病率的影响。在实施EPT计划之前和之后接受治疗的性伴侣的比例将根据对报告病例的随机样本的采访进行估计：调查人员将从社会角度以及相对于其他公共资助的控制淋病和衣原体感染的措施来评估干预的成本效益。

DESCRIPTION (provided by applicant): Neiserria gonorrhoeae and Chlamydia trachomatis are the two most common bacterial sexually transmitted infections (STI) in the United States, affecting an estimated 4 million persons annually at a cost of over $3 billion. After a period of declining morbidity, the prevalence of chlamydial infection is now rising in some areas of the U.S., while rates of gonorrhea are stable, but no longer decreasing. New public health interventions are needed to decrease morbidity from these infections. Improved partner notification and treatment might be such an intervention. Recent randomized controlled trials have demonstrated that expedited partner therapy (EPT), the practice of treating the sex partners of persons with curable STI without their mandatory prior examination by a clinician, can increase the number of partners of persons with gonorrhea or chlamydial infection treated, and can decrease rates of STI reinfection. Study investigators have shown that a public health EPT program can be instituted in a single city to increase partner treatment, but the feasibility of wider scale public health EPT programs has not been established, and the population-level impact and cost-effectiveness of larger EPT programs is unknown. This application proposes a stepped-wedge community-level randomized controlled trial of EPT for gonorrhea and chlamydial infection in Washington (WA) State. A population-based EPT program modeled after one already in place in King County, WA will be instituted in a randomly selected temporal order in 28 health districts in WA State. Free medication will be provided to patients to deliver to their sex partners, and a new case-reporting form will triage public health partner notification assistance to persons at high-risk for not notifying partners. Free medications will be distributed directly to patients via larger clinics in each health district and through a network of commercial pharmacies contracted to participate in the program. The study will assess the impact of EPT on the prevalence of chlamydial infection among women tested in clinics receiving CDC Infertility Prevention Project funding, and on the incidence of reported gonorrhea among women in the state. The proportion of sex partners treated before and after the institution of the EPT program will be estimated based on interviews with a random sample of reported cases: Investigators will evaluate the intervention's cost-effectiveness both from a societal perspective and relative to other publicly funded measures to control gonorrhea and chlamydial infection.