Evaluation of the immunologic and genital tract changes among Malawian women

马拉维妇女免疫和生殖道变化的评估

• 批准号: 8915789
• 负责人: Jennifer Tang
• 金额: $ 14.13万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8915789
• 关键词: Accounting; Acquired Immunodeficiency Syndrome; Africa South of the Sahara; African; Anti-Inflammatory Agents; Anti-inflammatory; Area; Benefits and Risks; Biological; CCR5 gene; CXCR4 gene; Cervical; Client; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Design; Cohort Studies; Collaborations; Conduct Clinical Trials; Contraceptive Agents; Contraceptive Method Switching; Contraceptive Usage; Contraceptive methods; Country; Data; Decision Making; Defensins; Enrollment; Epidemiologic Studies; Epidemiology; Epithelium; Evaluation; Family Planning; Family Planning Programs; Female; Funding; Future; Genital system; Goals; Gynecologist; HIV; Health; Healthcare; Hormonal; Hydrogen Peroxide; Immune system; Immunologics; Immunology; Implant; Infectious Diseases Research; Inflammatory; Injectable; Injection of therapeutic agent; Interferon Type II; Interleukin-10; Interleukin-6; International; Irrigation; K-Series Research Career Programs; Knowledge; Laboratory Study; Lactobacillus; Learning; Levonorgestrel; Longitudinal Studies; Malawi; Maternal Mortality; Medroxyprogesterone; Medroxyprogesterone 17-Acetate; Mentored Research Scientist Development Award; Mentors; Methods; Mucosal Immunity; North Carolina; Pathogenesis; Population Study; Populations at Risk; Predisposition; Prevention; Progestins; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recombinant DNA; Recommendation; Research; Research Design; Research Personnel; Research Priority; Resources; Risk; SLPI gene; Serum; Time; Universities; Virus Diseases; Woman; Women' s Health; antimicrobial; base; cervicovaginal; contraceptive efficacy; cytokine; design; experience; follow-up; hormonal contraception; insight; international center; multidisciplinary; prevent; programs; skills; trial comparing; unintended pregnancy

DESCRIPTION (provided by applicant): This is an application for a Fogarty International Center K01 International Research Scientist Development Award for Dr. Jennifer Tang, an obstetrician gynecologist specializing in family planning and global women's health at the University of North Carolina (UNC) at Chapel Hill. Dr. Tang is establishing herself as a young investigator in the areas of hormonal contraception and HIV prevention. This K01 award will provide Dr. Tang with the support necessary to accomplish the following goals: (1) to learn the fundamentals of immunological and genital tract markers related to HIV acquisition; (2) to gain experience in advanced study design and biostatistical analysis; (3) to become an expert in the design and implementation of randomized controlled trials in resource-limited settings; and (4) to develop skills in multidisciplinary, long-distance collaboration with clinical and basic scientits. To achieve these goals, Dr. Tang has assembled a mentoring team comprised of a U.S primary mentor, Dr. Jeffrey Stringer, Director of the UNC Global Women's Health Division and an internationally-recognized research expert in HIV prevention and treatment; a Malawi primary mentor, Dr. Mina Hosseinipour, Clinical Director of UNC Project-Malawi and an expert in HIV and infectious disease research in sub-Saharan Africa; Dr. Gretchen Stuart, Director of the UNC Family Planning Program and expert in interactions between hormonal contraception and HIV infection and treatment; Dr. William Miller, Director of the UNC Program in Health Care Epidemiology and Clinical Research and an expert in analytic methods and mentoring young investigators toward research independence; and Dr. Kristina Abel, Associate Director of the UNC Center for AIDS Research Immunology Core and an expert in mucosal immunity and the pathogenesis of HIV infection. Understanding the potential association between progestins (such as medroxyprogesterone or levonorgestrel) and HIV acquisition is currently a critical research priority for women's health researchers and policymakers. Dr. Tang's research will focus on elucidating this relationship by randomizing HIV-negative women to receive the depot medroxyprogesterone acetate (DMPA) injection or the Jadelle(R) levonorgestrel implant and comparing the immunologic changes (Aim 1) and genital tract changes (Aim 2) that occur after initiation of these contraceptives. In addition, her research will evaluate the feasibility and acceptability of conducting a long-term randomized controlled trial of DMPA versus Jadelle(R) in a sub-Saharan African population at-risk for HIV acquisition (Aim 3). Dr. Tang will randomize 30 women to DMPA or Jadelle(R) and evaluate serum and genital tract levels of antimicrobials, inflammatory cytokines, and anti-inflammatory cytokines at multiple time points before and after contraceptive initiation, for up to 2 years of contraceptive use. This study will form the basis fo a larger, multicenter clinical trial that will evaluate the risk for HIV acquisition among women usin DMPA , Jadelle(R), and other hormonal contraceptives. This trial will be submitted by Dr. Tang as an R01 application before the end of the 4-year career development award period.

描述（由申请人提供）：这是为 Jennifer Tang 博士申请福格蒂国际中心 K01 国际研究科学家发展奖的申请，Jennifer Tang 是北卡罗来纳大学教堂山分校 (UNC) 的一名妇产科医生，专门研究计划生育和全球妇女健康。唐博士正在将自己定位为激素避孕和艾滋病毒预防领域的年轻研究者。该K01奖将为唐博士提供实现以下目标所需的支持：（1）学习与HIV感染相关的免疫学和生殖道标志物的基础知识； (2) 获得高级研究设计和生物统计分析的经验； (3) 成为资源有限环境下随机对照试验设计和实施的专家； （4）培养与临床和基础科学家进行多学科、远距离合作的技能。为了实现这些目标，唐博士组建了一支由美国首席导师、北卡罗来纳大学全球妇女健康部门主任杰弗里·斯金格博士和国际公认的艾滋病预防和治疗研究专家组成的指导团队；马拉维首席导师 Mina Hosseinipour 博士，北卡罗来纳大学马拉维项目临床主任，撒哈拉以南非洲艾滋病毒和传染病研究专家； Gretchen Stuart 博士，北卡罗来纳大学计划生育项目主任，激素避孕与艾滋病毒感染和治疗之间相互作用的专家； William Miller 博士，北卡罗来纳大学卫生保健流行病学和临床研究项目主任，分析方法和指导年轻研究人员独立研究方面的专家；北卡罗来纳大学艾滋病研究免疫学核心中心副主任、粘膜免疫和艾滋病毒感染发病机制专家克里斯蒂娜·阿贝尔博士。了解孕激素（如甲羟孕酮或左炔诺孕酮）与艾滋病毒感染之间的潜在关联是目前妇女健康研究人员和政策制定者的一个重要研究重点。 Tang 博士的研究重点是通过随机分配 HIV 阴性女性接受长效醋酸甲羟孕酮 (DMPA) 注射剂或 Jadelle(R) 左炔诺孕酮植入剂，并比较开始使用这些避孕药后发生的免疫学变化（目标 1）和生殖道变化（目标 2）来阐明这种关系。此外，她的研究还将评估在撒哈拉以南非洲有艾滋病毒感染风险的人群中进行 DMPA 与 Jadelle(R) 长期随机对照试验的可行性和可接受性（目标 3）。 Tang 博士将随机将 30 名女性随机分配到 DMPA 或 Jadelle(R) 组，并在开始避孕之前和之后的多个时间点评估血清和生殖道抗菌药物、炎症细胞因子和抗炎细胞因子的水平，持续长达 2 年的避孕措施。这项研究将为一项更大规模的多中心临床试验奠定基础，该试验将评估使用 DMPA、Jadelle(R) 和其他激素避孕药的女性感染艾滋病毒的风险。该试验将由唐博士在 4 年职业发展奖励期结束前作为 R01 申请提交。