Understanding STI and HIV prevention adherence among Kenyan women

摘要 这项K23指导的以患者为导向的研究职业发展奖提案支持为期5年的研究 Jenell Stewart博士的培训计划，以使自己成为一名独立的调查员， 性传播感染和艾滋病毒预防。斯图尔特博士是一名传染病医生，科学家 在资源匮乏的环境中致力于STI和HIV研究的良好记录， 国际合作经验。对于这项提议，斯图尔特博士将受益于额外的培训， 包括正式的课程工作和辅导，在设计和分析性传播感染和艾滋病毒预防试验方面， 评估性暴露和事件驱动的依从性，以及性别权力的混合方法分析 动态的坚持行为。在过去的十年中，细菌性性传播感染的发病率显著增加， 世界各地的人口。除了感染艾滋病毒的风险增加外，肯尼亚年轻妇女的性传播感染率也很高。 具有严重后果的比率（例如，盆腔炎、输卵管性不孕症、妊娠并发症）。 暴露后预防（PEP）与抗生素强力霉素（dPEP）已被提议作为一种新的STI 控制策略，在男男性行为者中进行的dPEP试验正在进行中，其中一项已完成， 多个计划。这项K23提案将利用2009年在肯尼亚启动的妇女中的第一次dPEP试验， 2020年1月。与其他依赖合作伙伴参与的性传播感染预防战略相比， 将由妇女控制;然而，对肯尼亚人坚持性传播感染预防的行为知之甚少。 妇女了解非洲妇女对艾滋病毒暴露前预防（PrEP）的依从性是 准确定义该人群的有效性，同样，dPEP依从性也很重要， 并进行评估。我们假设，提供高依从性的dPEP将大大降低发生率 细菌性性病，特别是沙眼衣原体以及梅毒螺旋体和支原体 生殖器对M.在dPEP的母体随机试验中， 提供关于这一新兴性传播感染的独特数据。目的1将测量dPEP粘附对细菌STI的影响 通过在肯尼亚人中利用dPEP与标准风险降低咨询的随机试验进行保护 女性（N=446）随访12个月，使用头发药物浓度来确定依从性， 综合病例队列分析。目标2将评估最近诊断为性传播感染的影响， 后续纵向预防行为的护理STI测试（对dPEP和PrEP的依从性以及频率 无安全套性行为）使用自我报告的行为验证了生物措施。目标3将决定如何 性别权力动态与使用定量和定量分析的混合方法的坚持行为， 在初级性关系中的性别权力差异的定性测量。该提案将提供 这是避免妇女感染细菌性性传播感染和艾滋病毒而发病和死亡的重要证据。

ABSTRACT This K23 Mentored Patient-Oriented Research Career Development Award proposal supports a 5-year research and training program for Dr. Jenell Stewart to establish herself as an independent investigator with expertise in sexually transmitted infection (STI) and HIV prevention. Dr. Stewart is an Infectious Diseases physician-scientist with a strong track record of dedication to STI and HIV research in low-resource settings and extensive experience in international collaborations. For this proposal, Dr. Stewart will benefit from additional training, including formal course work and mentorship, in design and analysis of STI and HIV prevention trials, assessment of sexual exposures and event-driven adherence, and mixed-methods analysis of gendered power dynamics in adherence behavior. In the past decade, rates of bacterial STIs have increased markedly in populations worldwide. In addition to increased risk of HIV infections, young Kenyan women have very high STI rates with severe consequences (e.g., pelvic inflammatory disease, tubal infertility, complications of pregnancy). Post-exposure prophylaxis (PEP) with the antibiotic doxycycline (dPEP) has been proposed as a novel STI control strategy, and dPEP trials among men who have sex with men are ongoing with one completed and multiple planned. This K23 proposal will leverage the first trial of dPEP among women, launching in Kenya in January 2020. In contrast to other STI prevention strategies that rely on partner participation, on-demand dPEP would be woman-controlled; however, little is known about adherence behavior to STI prevention among Kenyan women. Understanding adherence to HIV pre-exposure prophylaxis (PrEP) in African women was key to accurately defining effectiveness in this population, and similarly dPEP adherence will be important to measure and evaluate. We hypothesize that provision of dPEP with high adherence will substantially reduce the incidence of bacterial STIs, particularly Chlamydia trachomatis as well as Treponema pallidum and Mycoplasma genitalium. The longitudinal evaluation of M. genitalium in women in the parent randomized trial of dPEP will provide unique data on this emerging STI. Aim 1 will measure the effect of dPEP adherence on bacterial STI protection by leveraging a randomized trial of dPEP versus standard risk-reduction counseling among Kenyan women (N=446) followed for 12 months using hair drug concentrations to determine adherence in a comprehensive case-cohort analysis. Aim 2 will assess the impact of a recent diagnosis with an STI from point- of-care STI testing on subsequent longitudinal prevention behavior (adherence to dPEP and PrEP and frequency of condomless sex) using self-reported behavior validated against biological measures. Aim 3 will determine how gendered power dynamics relate to adherence behavior using a mixed methods analysis of quantitative and qualitative measures of gendered power differentials in primary sexual relationships. This proposal will provide important evidence to avert morbidity and mortality from bacterial STI and HIV acquisition among women.