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最常见的两种细菌性性传播感染（STI），每年影响约400万人，费用超过30亿美元。经过一段时间的发病率下降，衣原体感染的流行率现在在美国的一些地区上升，而淋病发病率保持稳定，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是这样一种干预措施。最近的随机对照试验表明，快速伴侣治疗（EPT），即治疗可治愈性传播感染者的性伴侣而无需临床医生进行强制性事先检查的做法，可以增加接受治疗的淋病或衣原体感染者的伴侣数量，并可以降低性传播感染的再感染率。研究调查表明，一个公共卫生EPT计划可以在一个城市建立，以增加合作伙伴的治疗，但更大规模的公共卫生EPT计划的可行性尚未建立，人口水平的影响和成本效益的较大的EPT计划是未知的。本申请提出了一项在华盛顿（WA）州进行的EPT治疗淋病和衣原体感染的阶梯楔形社区水平随机对照试验。一个以人口为基础的EPT计划模仿一个已经在国王县，西澳将在一个随机选择的时间顺序在西澳州的28个卫生区。将向患者提供免费药物，以提供给他们的性伴侣，一种新的病例报告表将把公共卫生伴侣通知援助分类给那些不通知伴侣的高危人群。免费药物将通过每个卫生区的大型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对接受CDC不孕症预防项目资助的诊所检测的妇女衣原体感染患病率的影响，以及对该州妇女报告的淋病发病率的影响。在EPT计划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样本进行的访谈进行估计：研究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.