Investigating interactions between efavirenz-based antiretroviral therapy and contraceptive implants

研究基于依非韦伦的抗逆转录病毒疗法与植入式避孕药之间的相互作用

• 批准号: 9088349
• 负责人: Rena Chiman Patel
• 金额: $ 17.48万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9088349
• 关键词: Accounting; Address; Adherence; Africa South of the Sahara; Anti-Retroviral Agents; Antitubercular Agents; Atazanavir; Award; Behavioral; Biometry; Body mass index; California; Clinic; Clinical; Clinical Trials; Communicable Diseases; Comorbidity; Computerized Medical Record; Consequences of HIV; Contraceptive Agents; Contraceptive Usage; Contraceptive methods; Data; Data Analyses; Data Quality; Decision Making; Dose; Drug Interactions; Drug Kinetics; Ensure; Epidemiology; Etonogestrel; Failure; Funding; Future; Goals; Guidelines; HIV; HIV Seropositivity; Hair; Hepatic; Hormonal; Implant; Integration Host Factors; Interview; K-Series Research Career Programs; Kenya; Lead; Literature; Measures; Mentors; Methods; Nevirapine; Outcome; Patients; Pharmaceutical Preparations; Pharmacology; Plasma; Positioning Attribute; Pregnancy; Pregnancy Rate; Process; Progesterone; Provider; Qualitative Research; Recommendation; Regimen; Reporting; Reproductive Health; Research; Research Methodology; Research Personnel; Research Training; Resources; Retrospective Studies; Ritonavir; San Francisco; Series; Serum; Social Sciences; Structure; Swaziland; Time; Training; Universities; Validation; Vertical Disease Transmission; Weight; Woman; Women' s Health; Work; antiretroviral therapy; base; clinically significant; cohort; contraceptive efficacy; efavirenz; experience; hormonal contraception; implementation science; improved; maternal morbidity; novel; pregnant; prevent; public health relevance; skills; success; therapy adherence; treatment program; unintended pregnancy

 DESCRIPTION (provided by applicant): The overall goal of the proposed mentored career development award is to support Dr. Rena Patel's research training to develop as an independent, mixed methods researcher in HIV and women's health. Dr. Patel is currently an infectious diseases fellow at the University of California, San Francisco. Conducting the proposed studies in this application will facilitate her training goals of gaining a background in pharmacology, advancing her skills in epidemiology/biostatistics and qualitative research methods, and formalizing her experiences in implementation sciences. The proposal builds on the unique skills that she already has in the social sciences, qualitative research, and epidemiology while leveraging UCSF's world-class mentors, researchers, and facilities to ensure her success in becoming an independent investigator. The research objective of this proposal is to determine if interactions between efavirenz and contraceptive implants lead to contraceptive failures (i.e. unintended pregnancies). Unintended pregnancies among HIV-positive women impact HIV and maternal morbidity and vertical transmission of HIV. Optimizing contraception to avoid unintended pregnancies is imperative. Some pharmacokinetic data regarding drug-drug interactions between efavirenz and hormonal contraception have raised concerns for increased contraceptive failures. However, critical gaps exist in the literature and current HIV treatment guidelines with regard to concomitant use of efavirenz-based antiretroviral therapy (ART), now recommended as first-line ART in resource-limited settings, and contraceptive implants. In order to address the issue of potential interactions between efavirenz and implants comprehensively, we aim to conduct three distinct studies in western Kenya. For Aim 1, we will determine if implant etonogestrel concentrations decrease following initiation of efavirenz-based ART. For Aim 2, we will compare contraceptive failure or pregnancy rates among women using implants on efavirenz- vs. non-efavirenz based ART in a large clinic-based Kenyan cohort. Lastly, for Aim 3, we will determine how HIV-positive women, their partners, and providers reach decisions regarding concomitant ART and contraception initiation and choices, how potential data on interactions between ART and contraception would influence their choices, and to assess acceptability of alternative ART and/or contraceptive strategies. We hypothesize that implant etonogestrel concentrations will decrease following efavirenz-based ART initiation and pregnancy rates will be higher in implant users on efavirenz vs. non-efavirenz-based ART. The above aims will be among the first to comprehensively address the questions surrounding interactions between efavirenz-based ART and implants, and by the completion of this award, Dr. Patel will be in an excellent position to submit an R01 that furthers the research agenda in HIV and reproductive health.

 描述（由应用程序提供）：拟议的Mendored职业发展奖的总体目标是支持Rena Patel博士的研究培训，以发展为艾滋病毒和妇女健康的独立，混合方法研究人员。帕特尔博士目前是旧金山分校的传染病研究员。在此应用程序中进行拟议的研究将有助于她获得药理学背景的培训目标，推进她在流行病学/生物统计学和定性研究方法方面的技能，并提高她在实施科学方面的经验。该提案以她在社会科学，定性研究和流行病学中已经拥有的独特技能为基础，同时利用UCSF的世界一流的导师，研究人员和设施，以确保她成功成为独立研究者。该提案的研究目标是确定efavirenz与避孕作用之间的相互作用是否导致避孕失败（即意外怀孕）。艾滋病毒阳性妇女的意外怀孕影响艾滋病毒，孕产妇的发病率和艾滋病毒的垂直传播。优化避孕以避免意外怀孕是必须的。一些有关efavirenz和荷尔蒙避孕之间药物相互作用的药代动力学数据引起了人们对避孕失败增加的关注。然而，文献和当前的HIV治疗指南中存在关键差距，这些指南伴随使用基于efavirenz的抗逆转录病毒疗法（ART），现在建议在资源有限的环境中作为一线艺术和避孕剂。为了全面解决Efavirenz与Impants之间潜在相互作用的问题，我们旨在在肯尼亚西部进行三项不同的研究。对于AIM 1，我们将确定基于Efavirenz的ART主动行动后，植入物Etonogestel浓度是否降低。对于AIM 2，我们将比较在伊法维雷伦（Efavirenz）与非efavirenz的避孕失败或妊娠率中，在大型基于诊所的肯尼亚人群中的避孕失败或妊娠率。最后，对于AIM 3，我们将确定HIV阳性妇女，其伴侣和提供者如何做出有关伴随的艺术和避孕计划和选择的决定，如何对艺术与避孕之间的相互作用的潜在数据影响她们的选择，并评估替代艺术和/或避孕策略的可接受性。我们假设，在Efavirenz的ART主动性和妊娠率中，Efavirenz对基于非efavirenz的ART的植入使用者的植入物浓度将降低。上述目的将是第一个全面解决围绕埃法维雷伦（Efavirenz）艺术与即兴的互动问题的问题之一，并且通过完成该奖项，帕特尔（Patel 艾滋病毒的研究议程并再现了健康。