Do Condoms Protect From Non-Viral Sexually Transmitted Infections?

描述（由申请人提供）：最近的一份联邦报告建议，迫切需要对避孕套防止性传播感染（STIs）的有效性进行严格的测试。迄今为止，已发表的研究还没有描述避孕套有效性的测试。此外，对CRISP数据库的搜索显示，避孕套有效性的研究尚未得到资助。拟议的研究使用一种创新的方法来测试避孕套对阴茎阴道感染的有效性：a)衣原体，b)滴虫病，以及c)三种非病毒性性传播感染（衣原体，滴虫病和淋病）中的任何一种（目的1）。这些感染的负面后遗症是有充分记录的。这些感染也增加了艾滋病毒感染和传播的几率。由于男性和女性之间的保护价值很可能存在差异，因此该研究还将测试性别（gender）对避孕套有效性的调节作用（目标2）。根据拟议研究的PI进行的大量研究，也很明显，在避孕套有效性测试中必须考虑到各种形式的避孕套失效。因此，该研究将量化这些失效源导致的保护价值损失（目标3）。最后一项研究的目的是确定当避孕套使用频率从100%下降时所产生的保护价值损失（目标4）。样本为625名男性和625名女性（年龄在15岁至15岁之间），他们参加了两个诊所之一的性病评估和治疗。参与者将被随访6个月以上。在最初的测试（使用DNA扩增）和治疗（使用单剂量，直接观察治疗）现有的非病毒性性传播感染后，参与者将学习如何使用个人数字助理在接下来的6个月内保持电子性交日记。这种创新的数据收集方法有助于确保评估行为的最佳有效性。还将提供一个简短的教育会议。本次会议将促进在研究期间正确和持续地使用避孕套，从而有助于确保足够数量的参与者在分析中被归类为“100%”使用者。3个月的随访筛查将发现早期再感染或新感染。6个月的随访期间还将包括对三种性传播感染进行重新筛查。这项研究有足够的动力（bbb80 %）来检测即使是适度的效应大小。调查结果将被传播，以告知与使用避孕套预防这些常见的非病毒性性传播感染有关的公共卫生政策和规划。

DESCRIPTION (provided by applicant): A recent federal report suggested that rigorous tests of condom effectiveness against sexually transmitted infections (STIs) are urgently needed. 1 To date, published studies have not described tests of condom effectiveness. Further, a search of the CRISP database revealed that studies of condom effectiveness have not yet been funded. The proposed study uses an innovative approach to testing condom effectiveness against penile-vaginal acquisition of a) Chlamydia, b) trichomoniasis, and c) any of three non-viral STIs (Chlamydia, trichomoniasis, and gonorrhea) (Aim 1). The negative sequelae of these infections are well documented. The infections also increase the odds of HIV acquisition and transmission. Because the protective value is highly likely to vary between men and women, the study will also test for moderating effects of sex (gender) on condom effectiveness (Aim 2). Based on a substantial amount of research conducted by the PI of the proposed study, it is also quite apparent that various forms of condom failure must be accounted for in tests of condom effectiveness. Therefore the study will quantify the loss of protective value attributable to these sources of failure (Aim 3). A final study aim is to determine the loss of protective value incurred as the frequency of condom use decreases from 100% (Aim 4). The sample will be 625 men and 625 women (> 15 years of age) attending one of two clinics for the evaluation and treatment of an STI. Participants will be followed over 6 months. After initially being tested (using DNA amplification) and treated (using single-dose, directly observed therapy) for existing non-viral STIs, participants will learn how to use a Personal Digital Assistant to keep an electronic coital diary over the subsequent 6 months. This innovative method of data collection helps assure optimal validity of the assessed behaviors. A brief education session will also be provided. This session will promote the correct and consistent use of condoms during the study period thereby helping to ensure that an adequate number of participants are classified as "100%" users in the analyses. A 3-month follow-up screening will detect early reinfections or new infections. A 6-month follow-up period will also include re-screening for the three STIs. The study is adequately powered (> 80%) to detect even modest effect sizes. Findings will be disseminated to inform public health policy and programs related to the use of condoms in the prevention of these common, non-viral STIs.