A Randomized Trial of the Copper IUD versus DMPA for HIV Prevention in Women

带铜宫内节育器与 DMPA 预防女性艾滋病毒的随机试验

• 批准号: 8327411
• 负责人: Charles Morrison
• 金额: $ 10.78万
• 依托单位: FAMILY HEALTH INTERNATIONAL
• 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 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8327411
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adverse effects; Affect; Africa South of the Sahara; Age; Anti-Retroviral Agents; Applications Grants; Area; Budgets; Clinic Visits; Clinical Data; Clinical Trials; Cohort Studies; Consent Forms; Contraceptive Agents; Contraceptive Usage; Contraceptive methods; Contracts; Copper; Counseling; Data; Data Collection; Development; Enrollment; Funding; Future; Gel; Goals; Grant; HIV; HIV Infections; Heptanoates; Hormonal; Human Herpesvirus 2; Human immunodeficiency virus test; In Vitro; Incidence; Infection; Informed Consent; Injectable; Ions; Life; Manuals; Medroxyprogesterone 17-Acetate; Monitor; Norethindrone; Oral Contraceptives; Participant; Phase III Clinical Trials; Population; Pregnancy; Pregnancy Rate; Prevalence; Prevention approach; Procedures; Progestins; Prophylactic treatment; Protocols documentation; Public Health; Randomized; Recruitment Activity; Research Personnel; Risk; Safety; South Africa; Southern Africa; Tenofovir; Time; Training; Travel; Woman; Work; arm; clinical research site; data management; data sharing; eligible participant; follow-up; hormonal contraception; multidisciplinary; prevent; randomized trial; reproductive; research study; young woman

DESCRIPTION (provided by applicant): Over 33 million people worldwide are estimated to be living with HIV in 2009, with almost 16 million of these being women. Most live in Sub-Saharan Africa where 60% of HIV infections are in women. Sub-Saharan Africa also has a high proportion of women using hormonal contraception, particularly the injectable progestin depot-medroxyprogesterone acetate (DMPA). While recent studies have documented the efficacy of antiretroviral pre-exposure prophylaxis (PrEP) in reducing risk of HIV acquisition, in the CAPRISA-004 study, HIV incidence remained high (5.6 per 100 woman-years) in the experimental group receiving tenofovir gel; most women in this study used DMPA. Determining whether hormonal contraception has an effect on HIV acquisition is a critical unanswered public health issue. We are requesting funding to support initial development of a multi- center, randomized trial to evaluate the impact of use of the copper IUD versus DMPA for prevention of HIV acquisition in women. Secondary aims of the future trial are to evaluate whether age or HSV-2 infection status modifies any effect of contraceptive use on HIV acquisition, and whether study arm has any impact on pregnancy and contraceptive continuation rates. The trial will be conducted at 2-3 clinical research sites in Southern Africa. We will randomize women using or wanting to use injectable contraception to DMPA every 3 months or copper IUDs. Participants will return for clinic visits including HIV testing every 3 months for a period of one year. This R4 planning grant will be used to support investigators' time, travel, and supplies to: a) establish te multidisciplinary protocol team; b) identify collaborators and clinical sites that can successfully recruit, enroll, and follow-up sufficient numbers of eligible participants, and conduct appropriate informed consent, clinical and data collection procedures, c) develop necessary study documents including the study protocol, the statistical and data management plans and the study manual of procedures, d) develop a detailed budget for the entire research study period including for appropriate sub-contracts, and e) work with collaborators to develop informed consent forms and training materials. Completion of these aims is expected to result in the development and submission of an R01 grant application. We anticipate that the time dedicated to the R34 planning period will enhance the efficiency and quality of the future trial. With an estimated 2.6 million new HIV infections worldwide in 2009, the need for simple, effective and inexpensive prevention approaches is critical. If IUDs can lower the risk of HIV acquisition in a population of women who would otherwise use injectable contraceptives, our results could make an important contribution to the Millennium Development Goal of halting and beginning to reverse the spread of HIV/AIDS by 2015. PUBLIC HEALTH RELEVANCE: We are requesting funding to support initial development of a multi-center, randomized trial to evaluate the impact of use of the copper IUD versus DMPA for prevention of HIV acquisition in women. Because HIV infection primarily affects women of reproductive age, determining whether hormonal contraception has an effect on HIV acquisition is a critical unanswered public health question. The proposed Clinical Trial Planning Grant will support important planning activities for the clinical trial including the identification of collaborators and clinical sites, development of necessary study documents including the study protocol and manual of procedures and creation of a detailed budget for the trial.

描述(申请人提供)：据估计，2009年全球艾滋病毒携带者超过3300万人，其中近1600万为妇女。大多数人生活在撒哈拉以南非洲，那里60%的艾滋病毒感染是女性。撒哈拉以南非洲也有很高比例的妇女使用激素避孕，特别是注射孕激素仓库--醋酸甲羟孕酮(DMPA)。虽然最近的研究证明了抗逆转录病毒暴露前预防(PrEP)在降低艾滋病毒感染风险方面的有效性，但在CAPRISA-004研究中，服用替诺福韦凝胶的试验组的艾滋病毒发病率仍然很高(每100妇女年5.6人)；该研究中的大多数妇女使用DMPA。确定荷尔蒙避孕是否对艾滋病毒感染有影响是一个关键的、尚未回答的公共卫生问题。我们正在申请资金，以支持一项多中心随机试验的初步开发，以评估使用铜宫内节育器与DMPA预防妇女感染艾滋病毒的影响。未来试验的次要目标是评估年龄或HSV-2感染状况是否会改变避孕用具对HIV感染的任何影响，以及研究ARM是否对怀孕和避孕续用率有任何影响。这项试验将在南部非洲的2-3个临床研究地点进行。我们将每3个月将使用或希望使用可注射避孕药的妇女随机分配到DMPA或铜质宫内节育器。参与者将在为期一年的期间内每3个月返回诊所就诊，包括艾滋病毒检测。这笔R4规划赠款将用于支持研究人员的时间、旅行和用品，以：a)建立TE多学科礼仪团队；b)确定能够成功地 招募、登记和跟踪足够数量的合格参与者，并进行适当的 (C)制定必要的研究文件，包括研究方案、统计和数据管理计划以及程序研究手册；(D)制定整个研究研究期间的详细预算，包括适当的分包合同；(E)与合作者合作，编写知情同意书和培训材料。这些目标的完成预计将导致制定和提交R01赠款申请。我们预计，专门用于R34规划期的时间将提高未来试验的效率和质量。据估计，2009年全球新增艾滋病毒感染人数为260万人，因此迫切需要简单、有效和廉价的预防方法。如果宫内节育器能够降低使用可注射避孕药的妇女感染艾滋病毒的风险，我们的成果可以为到2015年阻止和开始扭转艾滋病毒/艾滋病传播的千年发展目标做出重要贡献。 公共卫生相关性：我们正在申请资金，以支持一项多中心随机试验的初步开发，以评估使用铜宫内节育器与DMPA预防妇女感染艾滋病毒的影响。由于艾滋病毒感染主要影响育龄妇女，因此确定激素避孕是否对艾滋病毒感染有影响是一个关键的、尚未回答的公共卫生问题。拟议的临床试验计划补助金将支持临床试验的重要规划活动，包括确定合作者和临床地点，制定必要的研究文件，包括研究方案和程序手册，以及为试验制定详细预算。