IMPAACT INVESTIGATIONS FOR FUTURE STUDIES

背景和导言 Eunice Kennedy Shriver国家儿童健康和人类发展研究所（NICHD）为国际母婴青少年艾滋病临床试验网络（IMPAACT）提供临床试验场地。IMPAACT网络是一个由机构、调查人员和其他合作者组成的合作小组，重点是预防和治疗婴儿、儿童、青少年和孕妇的艾滋病毒感染及其相关症状和合并感染。IMPAACT网络活动通过赠款/合作协议供资，由NIAID赞助，并由NICHD共同供资。IMPAACT网络及其领导小组（包括NICHD）负责创建所有研究、方案和临床试验。 IMPAACT网络的目标是开展高质量的临床试验和/或方案，以促进全球婴儿、儿童、青少年和孕妇/产后妇女艾滋病毒及其并发症的预防和治疗。IMPAACT研究议程包括四个具体目标，反映了其主要工作领域。这些领域是艾滋病毒治疗、艾滋病毒预防、艾滋病毒治疗和艾滋病毒并发症。对于每个领域，科学委员会由特定领域的专家、研究中心调查员、社区代表和中央网络资源的代表组成，根据新兴科学以及新的想法和机会不断重新评估研究优先事项;寻求与其他试验网络和研究实体的合作;监督基于科学优先事项的研究概念计划的制定和审查;并监察在其特定研究范畴内已获批准的网络研究的发展和实施情况。NICHD与NIAID赞助的HIV研究网络的合作始于1990年，扩大了NICHD资助的临床试验中心/地点的临床试验可用性。这种合作有助于IMPAACT网络进行临床试验，以进一步评估抗逆转录病毒治疗药物、针对机会性感染的其他疗法以及预防围产期艾滋病毒传播的干预措施。最近，合作范围扩大到评估潜在的艾滋病毒治疗方法和疫苗。 2019年5月，IMPAACT网络发布了一份题为“未来临床试验和次要/探索性研究目标所需的研究”的征求建议书，其主要目的是鼓励和支持有助于网络研究议程内未来临床试验所需知识基础的研究。调查人员被邀请提交可在2020年10月30日前完成的供资工作提案。该工作必须1）与次要或探索性 在选定的IMPAACT研究中规定的研究目的，这些研究在过去5年内结束随访，并且已完成主要分析，或2）与已完成的非网络研究相关（获得适当许可）。优先考虑被认为是该网络研究议程内未来临床试验基础的研究。 范围和目标 本任务指令将提供实施、支持和开展IMPAACT网络2019年5月RFP“未来临床试验所需的研究”中批准的特定研究提案所需的所有必要服务、合格人员、材料、设备和设施， 次要/探索性研究目标”，与IMPAACT网络的整体活动协调。 这项工作的总体目标是完成指定的IMPAACT网络批准的调查。这些项目的结果旨在扩大未来临床试验和次要或探索性研究目标所需的知识基础，其主要目的是为网络研究议程内的未来临床试验所需的知识基础做出贡献。这些调查拟在大约12个月内完成。

BACKGROUND and INTRODUCTION The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides clinical trial sites to the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). The IMPAACT network is a cooperative group of institutions, investigators, and other collaborators focused on prevention and treatment of HIV infection and its related symptoms and co-infections in infants, children, adolescents and pregnant women. IMPAACT network activities are funded through Grants/Cooperative agreements sponsored by NIAID and co-funded by NICHD. The IMPAACT network and its leadership group, which includes NICHD, are responsible the creation of all their studies, protocols, and clinical trials. The IMPAACT Network goal is to conduct high quality clinical trials and/or protocols that advance the prevention and treatment of HIV and its complications for infants, children, adolescents, and pregnant/postpartum women globally. The IMPAACT research agenda includes four specific aims, which reflect its key areas of work. Those areas are HIV Treatment, HIV Prevention, HIV Cure, and HIV Complications. For each area, a Scientific Committee composed of experts in the specific field, site investigators, community representatives, and representatives of the central network resources, continually reassesses the research priorities in light of emerging science as well as new ideas and opportunities; seeks collaboration with other trials networks and research entities; oversees the formulation and review of study concept plans based on the scientific priorities; and monitors the development and implementation of approved network studies in its specific research area. NICHD collaboration with NIAID sponsored HIV research networks began in 1990, expanding clinical trial availability across NICHD funded clinical trial centers/sites. This collaboration helped make possible clinical trials by the IMPAACT Network to further evaluate antiretroviral therapeutic agents, other therapies targeted at opportunistic infections, and interventions to prevent perinatal HIV transmission. More recently the collaboration has expanded to evaluate potential HIV cure approaches and vaccines. In May 2019 the IMPAACT Network issued a Request for Proposals entitled “Investigations Needed for Future Clinical Trials and Secondary/Exploratory Study Objectives” with a primary purpose to encourage and support investigations that contribute to the knowledge base necessary for future clinical trials within the network’s research agenda. Investigators were invited to submit proposals for funding work that could be completed by 30 October 2020. That work must be 1) associated with secondary or exploratory study objectives specified in selected IMPAACT studies that closed to follow-up within the last five years and for which the primary analyses have been completed or 2) associated with completed non-network studies (with appropriate permissions). Priority was given to investigations considered foundational for future clinical trials within the network’s research agenda. SCOPE AND OBJECTIVES This Task Order will provide all necessary services, qualified personnel, materials, equipment, and facilities needed to implement, support, and conduct specified study proposals approved under the IMPAACT Network May 2019 RFP “Investigations Needed for Future Clinical Trials and Secondary/Exploratory Study Objectives”, in coordination with overall activities of the IMPAACT network. The overall objective of this effort is to complete the specified IMPAACT network approved investigations. The results of these projects are intended to expand the knowledge base necessary for future clinical trials and secondary or exploratory study objectives, the primary purpose of which is to contribute to the knowledge base necessary for future clinical trials within the network’s research agenda. These investigations are intended to be completed within approximately 12 months.