Impact of Donor-imposed Requirements and Restrictions on Standards of Prevention and Access to Care and Treatment in HIV Prevention Trials

Impact of Donor-imposed Requirements and Restrictions on Standards of Prevention and Access to Care and Treatment in HIV Prevention Trials
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DOI:
10.1093/phe/phq027
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发表时间:
2010-11-01
影响因子:
2.1
通讯作者:
Heise, Lori
Heise, Lori
中科院分区:
人文科学2区
文献类型:
--
作者:
Philpott, Sean;Slevin, Katherine West;Heise, Lori

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全世界感染艾滋病毒/艾滋病的妇女人数正在增加,公共卫生迫切需要开发新的由使用者发起的艾滋病毒预防方法,包括杀微生物剂。虽然自2000年以来,对杀微生物剂开发的资金有所增加,但财政支助主要由政府机构和私人基金会提供。许多捐赠者,包括美国国际开发署(USAID)和美国国立卫生研究院(NIH),都有限制研究资金使用方式的政策。其中包括现已废除的墨西哥城政策,美国《对外援助法》的内容,以及对非学习相关护理的限制。这些限制对临床研究的设计和进行的影响还知之甚少。作为全球杀微生物剂运动最近进行的地图绘制工作的一部分,我们审查了捐赠者限制对七项艾滋病毒预防试验的影响。我们发现,在关于墨西哥城和其他政策是否以及如何影响研究资金使用的问题上,艾滋病毒预防领域存在相当大的混乱。我们还发现,捐助者强加的这些政策限制了向试验参与者提供的护理水平和开展的能力建设项目的类型。
The number of women living with HIV/AIDS is increasing worldwide, and there is an urgent public health need to develop new user-initiated HIV prevention methods, including microbicides. Although funding for microbicide development has increased since 2000, financial support is provided predominantly by governmental agencies and private foundations. Many donors, including the US Agency for International Development (USAID) and the US National Institutes of Health (NIH), have policies that restrict how research funds may be used. Among these are the now-rescinded Mexico City Policy, elements of the US Foreign Assistance Act, and restrictions on non-study-related care. The effect of these restrictions on the design and conduct of clinical research is poorly understood. As part of a recent mapping exercise conducted by the Global Campaign for Microbicides, we reviewed the impact of donor restrictions on seven HIV prevention trials. We found considerable confusion within the HIV prevention field as to whether and how Mexico City and other policies affect the use of research funds. We also found that these donor-imposed policies limited the level of care provided to trial participants and the types of capacity building projects undertaken.