Trichomonas vaginalis repeat infections among HIV negative women

HIV 阴性女性中阴道毛滴虫重复感染

• 批准号: 8331799
• 负责人: Patricia J Kissinger
• 金额: $ 78.24万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8331799
• 关键词: Adherence; Affect; African American; Antibiotic Therapy; Antibiotics; Bacterial Vaginosis; Biological Factors; Caring; Centers for Disease Control and Prevention (U.S.); Cervicitis; Chlamydia; Clinic; Clinical Treatment; Clinical Trials Design; Computer Assisted; Conflict (Psychology); Dose; Drug resistance; Effectiveness; Electronics; Failure; Future; Genotype; Goals; Gonorrhea; Guidelines; HIV; High Prevalence; In Vitro; Infection; Integration Host Factors; Intervention; Interview; Lead; Low Birth Weight Infant; Low income; Measures; Methodology; Methods; Metronidazole; Minority; Mission; Outcome; Patients; Pelvic Inflammatory Disease; Persons; Pharmaceutical Preparations; Phase; Predisposition; Premature Birth; Prevention Guidelines; Public Health; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Recording of previous events; Regimen; Reproductive Health; Research Design; Resistance; Risk; Sample Size; Screening procedure; Self-Administered; Sexual Partners; Sexually Transmitted Diseases; Simplexvirus; Source; Specimen; Testing; Tinidazole; Translations; Treatment Failure; Treatment Protocols; Trichomonas vaginalis; Urethritis; Vagina; Vaginitis; Woman; alternative treatment; arm; base; diaries; disorder prevention; follow-up; improved; indexing; men; microbiome; programs; reproductive; transmission process; treatment adherence

DESCRIPTION (provided by applicant): Trichomonas vaginalis (TV) infections are the most common treatable STI worldwide, and among women, are associated with poor reproductive health outcomes and possibly acquisition of HIV. Repeat TV infections are common and better treatment options are needed. This project will examine the influence of index treatment, host factors and partner treatment on repeat TV infections among HIV-negative women in three specific aims: Aim 1: Index treatment- Multi-dose (7 day 500 mg BID - alternative regimen) vs. single dose (2 g - recommended regimen) of MTZ for the treatment of TV. Aim 2: Host factors - To determine if altered vaginal flora, as measured by Nugent score, interferes with TV treatment. Aim 3: Partner treatment - To determine if patient delivered partner treatment is superior to partner referral for reducing repeat TV infections. These aims will be accomplished by conducting a phase IV, two factorial randomized clinical trial among TV infected HIV- negative women (N=2883) attending an STD in New Orleans, LA and an STD clinic in Jackson, MS. These public clinics serve mostly African American, low income women, the demographic group most highly affected by TV. Merging methodologies from our prior RCTs of these two interventions, women will be randomized to a single dose/PDPT, single dose/PR, multi-dose/PDPT or multi-dose/PR arm. Test of cure will be conducted at 1 month. Detailed sexual histories and treatment adherence will be collected weekly via electronic diaries and at one-month via computer-assisted self-administered interviews. Specimens of women who are TV+ at TOC will undergo MTZ susceptibility testing and TV genotyping (to compare baseline and follow-up types). Specimens will be stored for future microbiome studies of the vaginal flora. The information obtained from this study will be used to refine treatment recommendations and examine the translation of PDPT for use in the context of TV. Given the strong multi-centered, RCT design, and the large sample size, results should rapidly inform treatment guidelines thus having high impact. The ultimate goal is improved reproductive health for women, particularly minority women, and the reduction of the potential for HIV transmission, fitting well with NIAID's mission. PUBLIC HEALTH RELEVANCE: Determining the origin of repeat Trichomonas vaginalis infections and examining better treatment options can lead to better reproductive health and may reduce HIV transmission. Given the strong multicentered, RCT study design, and the large sample size, the results should rapidly inform treatment guidelines thus having high impact. The ultimate goal is improved reproductive health for women, particularly minority women, and the reduction of the potential for HIV transmission, fitting well with NIAID's mission.

描述（由申请人提供）：阴道毛滴虫（TV）感染是全球最常见的可治疗性传播感染，在女性中，与生殖健康结果不良和可能感染艾滋病毒有关。重复TV感染很常见，需要更好的治疗方案。该项目将在三个具体目标中检查索引治疗、宿主因素和伴侣治疗对HIV阴性女性中重复TV感染的影响：目标1：索引治疗-MTZ多剂量（7天500 mg BID -替代方案）与单剂量（2 g -推荐方案）治疗TV。目的2：宿主因素-确定阴道植物群改变（通过Nugent评分测量）是否干扰TV治疗。目的3：伴侣治疗-确定患者提供的伴侣治疗在减少重复TV感染方面是否优于伴侣转诊的上级治疗。这些目标将通过在路易斯安那州新奥尔良市的STD诊所和密西西比州杰克逊市的STD诊所就诊的TV感染的HIV阴性女性（N=2883）中进行IV期、双因子随机临床试验来实现。这些公共诊所主要为非洲裔美国人、低收入女性（受TV影响最大的人口群体）提供服务。合并我们之前关于这两种干预措施的RCT的方法，女性将被随机分配到单剂量/PDPT、单剂量/PR、多剂量/PDPT或多剂量/PR组。将在1个月时进行治愈测试。每周通过电子日记收集详细的性史和治疗依从性，并在1个月时通过计算机辅助自我管理访谈收集。TOC时TV+的女性样本将接受MTZ敏感性检测和TV基因分型（以比较基线和随访类型）。将储存标本，用于将来的阴道植物群微生物组研究。从这项研究中获得的信息将用于完善治疗建议，并检查在电视的背景下使用的PDPT的翻译。考虑到强有力的多中心RCT设计和大样本量，结果应迅速为治疗指南提供信息，因此具有很高的影响力。最终目标是改善妇女，特别是少数民族妇女的生殖健康，减少艾滋病毒传播的可能性，这完全符合国家艾滋病和艾滋病研究所的使命。 公共卫生相关性：确定阴道毛滴虫重复感染的起源并研究更好的治疗方案可以改善生殖健康，并可能减少艾滋病毒的传播。考虑到强有力的多中心、RCT研究设计和大样本量，结果应迅速告知治疗指南，因此具有很高的影响力。最终目标是改善妇女，特别是少数民族妇女的生殖健康，减少艾滋病毒传播的可能性，这完全符合国家艾滋病和艾滋病研究所的使命。