Expedited Partner Therapy as STI Control Among MSM in Peru
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Self-reported Partner Notification
研究概览
简要总结
Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent gonorrhea and chlamydia infection in heterosexual patients, but has not been evaluated for use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner management with heterosexual patients, but note the absence of evidence necessary to make an equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess the impact of EPT on partner notification, treatment, and STI re-infection among MSM are critical to the development of evidence-based partner management guidelines.
Recent data from urban Peru has identified prevalences of rectal and pharyngeal gonorrhea and chlamydia ranging from 5-20%. The elevated burden of disease among MSM in Peru suggests that frequent transmission of undiagnosed gonorrhea and chlamydia through MSM sexual networks may be a factor contributing to the persistently high incidence of HIV infection among MSM in the region. The investigators propose a pilot evaluation of the effect of EPT on partner notification and treatment among MSM in Peru diagnosed with gonorrhea or chlamydia at any anatomic site.
Specific Aim 1: To explore the social norms and structural factors influencing partner notification and treatment among MSM in Peru.
Specific Aim 2: To determine the effect of EPT on anticipated and actual partner notification among MSM diagnosed with gonorrhea or chlamydia infection.
Specific Aim 3: To develop preliminary data on rates of gonococcal and chlamydial re-infection among MSM randomized to receive EPT compared with standard partner notification counseling.
The proposed study will provide pilot data on the use of EPT with MSM diagnosed with gonorrhea or chlamydia and form the basis for a subsequent Phase III clinical trial of EPT as an STI control method among MSM in Latin America.
详细描述
Specific Aim 1: To determine the effect of Expedited Partner Therapy (EPT) on anticipated and actual partner notification among MSM diagnosed with gonorrhea or chlamydia infection.
The investigators believe that provision of EPT will alter the behavioral and social contexts of STI management in MSM partnerships by coupling the acts of partner treatment and partner notification. As a result, the investigators hypothesize that MSM provided with EPT will report higher rates of partner notification and treatment compared with men who receive standard partner notification counseling. Quantitative analysis of partner notification outcomes, using the specific examples of participants' five most recent sex partners, will provide a broad estimate of notification and treatment behaviors within the study population. Individual in-depth interviews with a diverse sub-set of participants will be used to provide further interpretive depth regarding the behavioral, social, and structural issues associated with anticipated and actual partner notification and treatment in specific interpersonal contexts, and to address logistical issues related to implementation of the intervention and the accuracy of the study's outcome measures for assessing participants' experiences of partner management.
Specific Aim 2: To collect preliminary data on rates of gonorrhea and chlamydia re-infection among MSM randomized to receive EPT compared with standard partner notification counseling.
The investigators anticipate that MSM provided with EPT will have a lower prevalence of persistent or recurrent urethral, rectal, or pharyngeal gonorrhea and/or chlamydia infection at the one-month follow-up visit compared with men who receive only standard partner notification counseling. Due to the exploratory nature of the proposed study, the investigators have not designed the protocol as an evaluation of the clinical effectiveness of EPT on STI re-infection among MSM. However, the data collected will provide essential preliminary information on the behavioral, social, and epidemiologic contexts of partner management among MSM in Peru needed to design a future clinical trial on the use of EPT as a network-based strategy for STI control among MSM.
Participants will be selected for participation in the study depending on the findings of the EPT/Partner Notification Screening Protocol. Participants in the EPT/Partner Notification Screening Protocol diagnosed with urethritis and/or proctitis, or Gonorrhea and/or Chlamydia in the urethra, rectum, or oropharynx will be eligible for enrollment in the EPT trial protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biologically male at birth
- •18 years of age or older
- •Sexual contact (oral or anal intercourse) with a male or male-to-female transgender person within the past 12 months.
- •Clinical Urethritis or proctitis OR Laboratory-diagnosed gonorrhea and/or chlamydia in any anatomic site (urethra, rectum, or oropharynx)
排除标准
- •Under 18 years of age
- •Anatomically female at birth
- •Unable to understand study procedures or provide informed consent
结局指标
主要结局
Self-reported Partner Notification
时间窗: 21 Days
Participant self-report of partner notification 14-21 days after randomization
次要结局
未报告次要终点
研究者
Jesse Clark
Assistant Professor-in-Residence
University of California, Los Angeles