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: 8900734
• 负责人: Patricia J Kissinger
• 金额: $ 78.01万
• 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 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8900734
• 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; 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; Multicenter Trials; 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; 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; screening; transmission process; treatment adherence; trial design

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.

描述(申请人提供)：阴道毛滴虫(TV)感染是全世界最常见的可治疗的性传播感染，在妇女中，与不良的生殖健康结果和可能获得艾滋病毒有关。反复的电视感染很常见，需要更好的治疗方案。本项目将从三个具体目标来研究指标治疗、宿主因素和伴侣治疗对HIV阴性妇女重复TV感染的影响：目的1：指标治疗-MTZ多剂量(7天500 mg，2次/d)与单剂(2g推荐方案)治疗TV。目的2：宿主因素--根据纽金特评分确定阴道菌群改变是否干扰电视治疗。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。这些目标将通过对电视感染艾滋病毒阴性妇女(N=2883)进行IV期两因素随机临床试验来实现，这些妇女在洛杉矶新奥尔良的STD和杰克逊的STD诊所就诊。这些公共诊所主要服务于非裔美国人低收入妇女，这是受电视影响最大的人口群体。合并了我们之前这两种干预措施的随机对照试验方法，妇女将被随机分为单剂/PDPT、单剂/PR、多剂/PDPT或多剂量/PR组。在1个月时进行治愈试验。详细的性史和治疗依从性将通过电子日记每周收集一次，并通过计算机辅助的自我管理访谈收集一个月。TOC中TV+的女性样本将接受MTZ敏感性测试和TV基因分型(以比较基线和随访类型)。标本将被储存起来，用于未来对阴道菌群的微生物组研究。从这项研究中获得的信息将被用来完善治疗建议，并检查在电视背景下使用的PDPT的翻译。考虑到强有力的多中心随机对照试验设计和大样本量，结果应该迅速为治疗指南提供信息，从而产生很大的影响。最终目标是改善妇女，特别是少数族裔妇女的生殖健康，减少艾滋病毒传播的可能性，这非常符合NIAID的使命。