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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

基本信息

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
项目类别：
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&apos 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

项目摘要

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.