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

描述（由申请人提供）：淋病奈瑟菌和沙眼衣原体是美国两种最常见的细菌性传播感染（STI），每年影响约400万人，成本超过30亿美元。在发病率下降一段时间后，衣原体感染的流行率现在在美国的一些地区上升，而淋病的发病率稳定，但不再下降。需要新的公共卫生干预措施来降低这些感染的发病率。改善伴侣通知和治疗可能就是这样一种干预措施。最近的随机对照试验表明，加速性伴侣治疗（EPT），即治疗可治愈性传播感染患者的性伴侣而无需临床医生强制事先检查的做法，可增加接受治疗的淋病或衣原体感染患者的性伴侣数量，并可降低性传播感染再感染率。研究人员已经表明，公共卫生EPT计划可以在单个城市建立，以增加伴侣治疗，但更大规模的公共卫生EPT计划的可行性尚未建立，更大规模的EPT计划的人口水平影响和成本效益尚不清楚。本申请在华盛顿州提出了一项阶梯形社区水平的EPT治疗淋病和衣原体感染的随机对照试验。一个以人口为基础的EPT项目将仿效西澳金县已经实施的项目，在西澳州的28个卫生区按随机选择的时间顺序建立。将向患者提供免费药物，以便将其提供给其性伴侣，新的病例报告表格将为未通知伴侣的高危人群提供公共卫生伴侣通知援助。免费药物将通过每个卫生区较大的诊所和参与该计划的商业药房网络直接分发给患者。该研究将评估EPT对在接受CDC不孕不育预防项目资助的诊所接受检测的妇女衣原体感染流行率的影响，以及对该州报告的妇女淋病发病率的影响。在EPT项目实施前后接受治疗的性伴侣比例将根据对报告病例的随机抽样进行访谈来估计：调查人员将从社会角度和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措施的成本效益。

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.